- Email: [email protected]
302 QUALITY OF LIFE IN ELDERLY PATIENTS WITH OBSTRUCTIVE SLEEP APNEA SYNDROME (OSAS)
Abstracts of 3rd International Congress of the Association of Sleep Medicine (WASM) / Sleep Medicine 10, Suppl. 2 (2009) S1–S83
299
OBESITY AND OBSTRUCTIVE SLEEP APNEA: LIFESTYLE INTERVENTION WITH WEIGHT REDUCTION AS A FIRST LINE TREATMENT
H. Tuomilehto 1 , J. Seppä 1 , H. Gylling 2 , M. Partinen 3 , M. Uusitupa 2 . 1 Institute of Clinical Medicine, Otorhinolaryngology, Kuopio University Hospital, and University of Kuopio, Finland; 2 School of Public Health and Clinical Nutrition, University of Kuopio, Finland; 3 Helsinki Sleep Research Center, Helsinki, Finland Aims: We had previously demonstrated that a more aggressive treatment of obesity in obstructive sleep apnea (OSA) patients is well-founded. Lifestyle intervention that lasts at least one year with an early VLCD was shown to be a feasible, low-cost and curative treatment for the vast majority of patients with mild OSA. The accompanying weight reduction also resulted in an improvement of the obesity-related risk factors for cardiovascular diseases. The aim of this randomized two-year follow-up study was to determine whether the beneficial effects of supervised lifestyle counseling could be sustained by the individual alone during the following year, in a post-interventional follow-up. Methods: Seventy-one consecutive overweight patients with mild OSA were recruited. The intervention group (N=35) completed the lifestyle modification, and the control group (N=36) received routine lifestyle counseling. The apnea-hypopnea index (AHI) served as the main objectively measured outcome variable. Change in symptoms served as a subjective measurement of outcome and as a biochemical parameter for the evaluation of cardiovascular risk. Results: The lifestyle intervention was found to effectively reduce body weight (-10.3±6.9 kg, mean±SD), which was accompanied by a reduced AHI. The mean change in AHI was significantly different between the two study groups (P=0.019). The adjusted odds ratio for having mild OSA was markedly lowered (OR=0.23 [95% CI: 0.08-0.72, P=0.011]) in the intervention group. All of the common symptoms related to OSA improved after the lifestyle intervention. In addition, there were marked improvements in metabolic parameters. Conclusions: Lifestyle intervention should be considered as a first line treatment for overweight patients with mild OSA. Even after a 1-year postinterventional period, the beneficial effects of the active lifestyle counseling were still having a positive impact, with continued weight reduction and improvements in the severity and symptoms of OSA and other obesity-related risk factors for cardiovascular disease. Conflicts of interest: None
300
VALIDATION OF THE SIDE EFFECTS OF CPAP INVENTORY (SECI)
M. Ulander 1 , P. Johansson 2 , K. Franzén 3 , A. Ståhlkrantz 4 , E. Svanborg 1 , A. Broström 1 . 1 Department of Clinical Neurophysiology, Inst for Clinical and Experimental medicine, Linkoping University, Linkoping Sweden; 2 Department of Cardiology, Inst for Medicine and Care, Linkoping University, Linkoping, Sweden; 3 School of Nursing, Kalmar University College, Kalmar, Sweden; 4 Department of Internal Medicine, Ryhov County Hospital, Jonkoping, Sweden Introduction: Despite wide-spread agreement that CPAP adherence in OSAS patients is unsatisfactory and that many patients complain about side effects, a validated questionnaire has yet to be developed that assesses CPAP-related side effects. There is a need for a standardized method to assess side effects, both for research purposes and in clinical work. Objectives: To develop and validate an instrument to measure CPAP-related side effects, namely the Side Effects of CPAP Inventory (SECI). Methods: Fifteen side effects were included in the questionnaire. They were based on a review of previous research, the consensus of a reference group of physicians and nurses who specialized in sleep medicine, as well as on interviews with 23 CPAP users. For each side effect, the respondent rated the frequency, magnitude and effect on CPAP adherence on separate 5-point Likert scales. Content validity was assessed by an expert group. Criterion validity was assessed in a cross-sectional study by distributing the SECI to 350 CPAP users (age 60.3, SD 9.3, mean AHI pre-CPAP 43.7 ranging from 10-92, duration of CPAP use 39 months) comparing the respondent’s score to their subjective and objective (machine data) CPAP adherence. An exploratory factor analysis was performed, and standard methods of classical test theory were used to assess the psychometric properties of the SECI. Results: Content validity was deemed as good. The response rate was 94%. Median scores on both the magnitude and adherence subscales were significantly higher among non-adherent patients. The factor analysis yielded
S81
a two-factor solution with items regarding device-related complaints (e.g., machine noise and mask leaks) in one factor and items regarding symptoms (e.g., dry mouth and runny nose) on the other. The internal consistency reliability of the three scales was good (Cronbach’s a=0.74-0.86) and acceptable for the subscales (Cronbach’s a=0.62-0.86). The “nose bleed” side effect demonstrated weak item-total correlations for all scales. Conclusion: The SECI is a new, validated inventory with good psychometric properties for assessing the side effects of CPAP among OSAS patients. It can differentiate between adherent and non-adherent users. A validated inventory for CPAP side effects is of importance in CPAP adherence research as well as in clinical practice. Further research is necessary to determine the predictive validity, confirm the factor structure and decide the minimum clinically significant change.
301
MONITORING OF AMBULATORU BLOOD PRESSURE IN CHILDREN WITH OBSTRUCTIVE SLEEP APNEA
S.A.T. Weber, V.J.B. Santos, L.C. Martin, G.O. Semenzati. UNESP - Faculdade de Medicina de Botucatu Introduction: Obstructive sleep apnea (OSA) is associated with cardiovascular injury and is caused by intermittent hypoxia and elevation of circulating catecholamines. Few studies on OSA have been performed in children. Aim: To study the 24-hours monitored blood pressure in children with OSA to identify the presence of the nocturnal physiologic drop in blood pressure and peaks of hypertension during diurnal and nocturnal period. Methods: OSA children, both genders, aged 8 to 12 years, underwent 24hours blood pressure monitoring. Children with known cardiopaty, hypertension, neurologic disorders or using sympathetic medication were excluded. The monitoring detected physiologic nocturnal drop in blood pressure and hypertension peaks during the day or night. Results: Twenty-four children were included, 18 were male, and the median age was 11 years. Eight children did not show physiologic nocturnal drop in blood pressure, and 4 children showed hypertensive peaks during the night. Conclusion: OSA in children seems to be associated with loss of nocturnal physiologic drop in blood pressure as well as development of hypertension or other cardiovascular diseases. Otolaryngologist and pediatricians must be aware of these conditions to improve diagnosis and prevention of OSA in children.
302
QUALITY OF LIFE IN ELDERLY PATIENTS WITH OBSTRUCTIVE SLEEP APNEA SYNDROME (OSAS)
F.T. Yagihara, L.M. Lucchesi, S. Tufik, L.R.A. Bittencourt. UNIFESP Introduction: There is an increased prevalence of OSAS in individuals around 55 years of age. In patients who are older than 65, on the other hand, there is an increased prevalence of apnea-hypopnea index (AHI) greater than 15/hour. In addition to the resulting sleep impairment, OSAS has an independent impact on other aspects of the quality of life in adults, and CPAP can have a substantial impact on this issue. However, studies on OSAS in the aging population are scarce. Methods: The study population included male volunteers who were older than 60 years, had a BMI lower than 35 kg/m2 , and had a clinical and polysomnographic diagnosis of OSAS as well as healthy control individuals. Both groups were submitted to an initial evaluation that consisted of a clinical examination and a quality of life questionnaire (SF-36). The OSAS group was then allocated to treatment with CPAP for at least six months, while the control group received no intervention. After this period, both groups answered the same quality of life questionnaire. Results: Twenty-nine patients with OSAS and twenty-seven age-matched controls (66.5±0.7 vs. 66.5±0.7, respectively; p=NS) were compared. The median ± SD of the AHI was 42±16.5 in the OSAS group and 5.3±3 in control group (p<0.001). The initial comparison between the two groups showed a significant difference, with worse quality of life scores in the OSAS patients in domains, such as physical functioning (PF) (p=0.01), role limitations due to physical health problems (RLDPH) (p=0.03) and bodily pain (BP) (p=0.01). However, there were no intragroup differences for the OSAS patients before and after CPAP, except for BP. In fact, there was an increase in BP scores after treatment compared to baseline (65±29 vs. 77.5±23; p<0.001). Conclusion: We observed impairments in elderly patients with OSAS with respect to various domains that affect quality of life. After CPAP treatment,
S82
Abstracts of 3rd International Congress of the Association of Sleep Medicine (WASM) / Sleep Medicine 10, Suppl. 2 (2009) S1–S83
there was an improvement in the domain of bodily pain. This finding could be explained by the association of OSAS with the inflammatory processes that cause pain, which can be reversed with treatment. Support: AFIP, FAPESP (2007/06232-0), CNPq
303
PERIPHERAL VASOCONSTRICTION AND NOCTURNAL BLOOD PRESSURE CONTROL IN HYPERTENSIVE SLEEP APNEA PATIENTS
D. Zou 1 , L. Grote 1 , D.N. Eder 1 , J. Radlinski 2 , Y. Peker 3 , J. Hedner 1 . 1 Sleep Laboratory, Department of Pulmonary Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden; 2 Department of Pathophysiology of Respiratory System, Institute for Tuberculosis and Lung Diseases Rabka-Zdrój Branch, Rabka-Zdrój, Poland; 3 Sleep Medicine Unit, Department of Neurology and Rehabilitation Medicine, Skaraborg Hospital, Skövde, Sweden Objective: Pulse wave attenuation that occurs in association with obstructive sleep apnea (OSA) is sympathetically mediated. Doxazosin (DO) is a peripheral α-receptor inhibitor, and Enalapril (EN) is an ACE inhibitor. The aim of this study was to compare the effects of DO and EN on digital vasoconstriction and nocturnal blood pressure (BP) control in hypertensive OSA patients. Methods: A double-blind crossover study on DO (4 mg/day for 2 weeks, followed by 8 mg/day for an additional 2 weeks) and EN (10 mg/day and 20 mg/day, respectively) was undertaken in 14 OSA patients with hypertension. The patients had a mean age of 55±7 years and a mean body mass index of 30.1±3.8 kg/m2 . The patient assessment, which was performed at the end of each treatment period, included ambulatory 24-hour BP, a full-night polysomnography with simultaneous peripheral arterial tonometry (PAT) and beat-to-beat finger BP monitoring (Finapres). Nighttime BP and digital vasoconstrictions, which are associated with apneic events and are measured by the PAT ratio, were analyzed. Results: There was no difference between the two treatments for either the 24-hour BP profile or the severity of OSA. There was, however, a significant difference between the DO and EN treatments with respect to the nighttime beat-to-beat finger BP (systolic BP 129±13 vs. 119±23 mmHg, P=0.02; diastolic BP 81±12 vs. 74±14 mmHg, P=0.04). In a linear mixed effects regression model, the PAT ratio increased 8.3% after treatment with DO compared to treatment with EN (P<0.0001). Each percentage of SaO2 desaturation and each second of apnea length were associated with a 0.7% and 0.3% decrease in the PAT ratio, respectively (P<0.0001). REM sleep was associated with a 2.7% increase in the PAT ratio in contrast to that of NREM sleep. Conclusion: Digital vasoconstriction that is associated with apneic events is α-receptor mediated. DO appear to have a proportionally worse effect on nocturnal BP control when compared with that of EN in hypertensive OSA patients.
Treatment Outcome Clinical Trial Research
304
A RANDOMIZED, DOUBLE-BLIND, 6-WEEK, DOSE-RANGING STUDY OF PREGABALIN IN SUBJECTS WITH RESTLESS LEGS SYNDROME
R. Allen 1 , C. Chen 2 , A. Soaita 2 , C. Wohlberg 3 , L. Knapp 2 , D. Garcia-Borreguero 4, J. Miceli 2 . 1 Johns Hopkins Department of Neurology, Baltimore, MD, USA; 2 Pfizer Global Research and Development, New London, CT, USA; 3 Pfizer Global Research and Development, New York, NY, USA; 4 Sleep Research Institute, University of Madrid, Madrid, Spain Introduction: Clinical data suggest pregabalin as a potential treatment for primary restless legs syndrome (RLS). Objectives: To characterize the dose-response relationship of pregabalin with respect to both efficacy and safety, in patients with idiopathic RLS. Methods: This was a 6-week, randomized, double-blind, placebo-controlled, dose-ranging study of pregabalin in adults with moderate to severe idiopathic RLS. Eligible patients were randomly assigned a fixed-dose pregabalin 50, 100, 150, 300, and 450 mg/day or a placebo. Assessments were conducted at baseline and in weeks 1, 2, 4, and 6. The primary endpoint was change from baseline to week 6 in the International Restless Legs Syndrome Scale
(IRLS) total score. Secondary endpoints included Clinical Global Impressions - Improvement Scale (CGI-I) responders, sleep assessments, other global and quality of life assessments and safety/tolerability. Results: A total of 137 patients participated in the study, randomly distributed into 6 similar-sized groups. At baseline, mean (SD) IRLS total scores for placebo, 50, 100, 150, 300, and 450 mg/day pregabalin groups were 23.8 (7.2), 24.6 (6.7), 25.3 (6.4), 26.2 (7.4), 25.0 (7.4), and 24.1 (7.8), respectively; the least square mean (SE; P value) differences in change from baseline to week 6 in IRLS total score (pregabalin vs. placebo) were -4.1 (2.5; P=0.0983), -4.0 (2.4; P=0.0966), -8.3 (2.5; P=0.0013), -5.2 (2.4; P=0.0353), and -8.5 (2.5; P=0.0006), respectively. From the dose-response analysis, a pregabalin dose of 123.9 mg/day was estimated to produce a 90% maximal effect in reducing RLS symptoms. Predicted mean changes from baseline to week 6 in IRLS scores using a dose response E-max model indicated that pregabalin doses of 100 to 450 mg/day corresponded to at least an average 13.6 point-reduction (at least an average 6-point placebo-corrected treatment difference). The percentage of CGI-I responders was numerically greater among patients who received pregabalin 300 or 450 mg/day compared with patients receiving placebo or lower doses of pregabalin at the last observation. The most common adverse events were dizziness, somnolence, fatigue, dry mouth and headache. Conclusions: This dose-ranging study showed that pregabalin reduced RLS symptoms in a dose-related manner with doses >150 mg/day providing significant symptom reduction. Pregabalin was safe and well tolerated across the entire dosing range. Support: Funded by Pfizer Inc.
305
EVALUATION OF A LOW-COST ORAL APPLIANCE: A PILOT STUDY
J.J. Cervo 1 , R.C. Langien 1 , S.C. Fagondes 2 , S.W. Samuel 1 , M.L. Grossi 3 , S.S. Menna Barreto 2 . 1 UFRGS; 2 HCPA; 3 PUCRS Introduction: Oral appliances (OA) are recommended for primary snoring and for patients with mild to moderate obstructive sleep apnea (OSA). They do have some advantages over CPAP treatment such as improved comfort and lower costs. OSA is an increasing public health problem, thus, concerns about the economical aspects of its treatment are very important, especially in Brazil, a developing country. The purpose of this study was to investigate the efficacy of a modified monobloc OA made with inexpensive materials for the treatment of patients with mild to moderate OSA, for further investigation. Methods: Five male patients with BMI less than 30 kg/m2 and an apnea/hypopnea index (AHI) less than 30 events/h according to the baseline polysomnography (PSG) were treated with a low-cost modified monobloc OA. They used the OA during a mean period of 86,8±4,21 nights. A second PSG was performed with patients using the OA. The following variables were evaluated: AHI, average oxygen saturation (SpO2), minimum SpO2 (nadir SpO2) and subjective daytime sleepiness evaluation (Epworth Sleepiness Scale). Results: The mean BMI was 28,6±0,39 kg/m2 and mean age was 51,8 years old (range 46 to 60 years old). PSG showed statistically significant mean reduction of 83,5%, from baseline AIH (11,26±4,12 events/h) to AHI with OA (2,31±2,23 events/h). Nadir SpO2 increased from 86±3,4 to 90,4±1,3, with a mean increase of 4,87%. The average SpO2 did not change for the two groups. There was a mean reduction of one point in the Epworth Sleepiness Scale (Signal Test, p<0,05). No clinical complication was noticed in any participant, on teeth or soft tissues. Conclusion: This easy assembly and low-cost modified model of OA improved the outcomes and presented no complications in a small group of OSA patients and may be an appropriate alternative to be used in a larger investigation.
306
THE INFLUENCE OF TREATMENT BY CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) ON HEART FUNCTION
M. Hobzova 1 , E. Sovova 2 , M. Sova 3 , K. Langova 4 , V. Kolek 1 . 1 Dept. of Pneumology, University Hospital Palacky University, Olomouc, Czech Republic; 2 I. Internal Dept., University Hospital Palacky University, Olomouc, Czech Republic; 3 Fac. of medicine and Dentistry, Palacky University, Olomouc, Czech Rep; 4 Dept. of Medical Biophysics, Palacky University, Olomouc, Czech Republic Objectives: The aim of the study was to evaluate the effects of CPAP treat-
299
OBESITY AND OBSTRUCTIVE SLEEP APNEA: LIFESTYLE INTERVENTION WITH WEIGHT REDUCTION AS A FIRST LINE TREATMENT
H. Tuomilehto 1 , J. Seppä 1 , H. Gylling 2 , M. Partinen 3 , M. Uusitupa 2 . 1 Institute of Clinical Medicine, Otorhinolaryngology, Kuopio University Hospital, and University of Kuopio, Finland; 2 School of Public Health and Clinical Nutrition, University of Kuopio, Finland; 3 Helsinki Sleep Research Center, Helsinki, Finland Aims: We had previously demonstrated that a more aggressive treatment of obesity in obstructive sleep apnea (OSA) patients is well-founded. Lifestyle intervention that lasts at least one year with an early VLCD was shown to be a feasible, low-cost and curative treatment for the vast majority of patients with mild OSA. The accompanying weight reduction also resulted in an improvement of the obesity-related risk factors for cardiovascular diseases. The aim of this randomized two-year follow-up study was to determine whether the beneficial effects of supervised lifestyle counseling could be sustained by the individual alone during the following year, in a post-interventional follow-up. Methods: Seventy-one consecutive overweight patients with mild OSA were recruited. The intervention group (N=35) completed the lifestyle modification, and the control group (N=36) received routine lifestyle counseling. The apnea-hypopnea index (AHI) served as the main objectively measured outcome variable. Change in symptoms served as a subjective measurement of outcome and as a biochemical parameter for the evaluation of cardiovascular risk. Results: The lifestyle intervention was found to effectively reduce body weight (-10.3±6.9 kg, mean±SD), which was accompanied by a reduced AHI. The mean change in AHI was significantly different between the two study groups (P=0.019). The adjusted odds ratio for having mild OSA was markedly lowered (OR=0.23 [95% CI: 0.08-0.72, P=0.011]) in the intervention group. All of the common symptoms related to OSA improved after the lifestyle intervention. In addition, there were marked improvements in metabolic parameters. Conclusions: Lifestyle intervention should be considered as a first line treatment for overweight patients with mild OSA. Even after a 1-year postinterventional period, the beneficial effects of the active lifestyle counseling were still having a positive impact, with continued weight reduction and improvements in the severity and symptoms of OSA and other obesity-related risk factors for cardiovascular disease. Conflicts of interest: None
300
VALIDATION OF THE SIDE EFFECTS OF CPAP INVENTORY (SECI)
M. Ulander 1 , P. Johansson 2 , K. Franzén 3 , A. Ståhlkrantz 4 , E. Svanborg 1 , A. Broström 1 . 1 Department of Clinical Neurophysiology, Inst for Clinical and Experimental medicine, Linkoping University, Linkoping Sweden; 2 Department of Cardiology, Inst for Medicine and Care, Linkoping University, Linkoping, Sweden; 3 School of Nursing, Kalmar University College, Kalmar, Sweden; 4 Department of Internal Medicine, Ryhov County Hospital, Jonkoping, Sweden Introduction: Despite wide-spread agreement that CPAP adherence in OSAS patients is unsatisfactory and that many patients complain about side effects, a validated questionnaire has yet to be developed that assesses CPAP-related side effects. There is a need for a standardized method to assess side effects, both for research purposes and in clinical work. Objectives: To develop and validate an instrument to measure CPAP-related side effects, namely the Side Effects of CPAP Inventory (SECI). Methods: Fifteen side effects were included in the questionnaire. They were based on a review of previous research, the consensus of a reference group of physicians and nurses who specialized in sleep medicine, as well as on interviews with 23 CPAP users. For each side effect, the respondent rated the frequency, magnitude and effect on CPAP adherence on separate 5-point Likert scales. Content validity was assessed by an expert group. Criterion validity was assessed in a cross-sectional study by distributing the SECI to 350 CPAP users (age 60.3, SD 9.3, mean AHI pre-CPAP 43.7 ranging from 10-92, duration of CPAP use 39 months) comparing the respondent’s score to their subjective and objective (machine data) CPAP adherence. An exploratory factor analysis was performed, and standard methods of classical test theory were used to assess the psychometric properties of the SECI. Results: Content validity was deemed as good. The response rate was 94%. Median scores on both the magnitude and adherence subscales were significantly higher among non-adherent patients. The factor analysis yielded
S81
a two-factor solution with items regarding device-related complaints (e.g., machine noise and mask leaks) in one factor and items regarding symptoms (e.g., dry mouth and runny nose) on the other. The internal consistency reliability of the three scales was good (Cronbach’s a=0.74-0.86) and acceptable for the subscales (Cronbach’s a=0.62-0.86). The “nose bleed” side effect demonstrated weak item-total correlations for all scales. Conclusion: The SECI is a new, validated inventory with good psychometric properties for assessing the side effects of CPAP among OSAS patients. It can differentiate between adherent and non-adherent users. A validated inventory for CPAP side effects is of importance in CPAP adherence research as well as in clinical practice. Further research is necessary to determine the predictive validity, confirm the factor structure and decide the minimum clinically significant change.
301
MONITORING OF AMBULATORU BLOOD PRESSURE IN CHILDREN WITH OBSTRUCTIVE SLEEP APNEA
S.A.T. Weber, V.J.B. Santos, L.C. Martin, G.O. Semenzati. UNESP - Faculdade de Medicina de Botucatu Introduction: Obstructive sleep apnea (OSA) is associated with cardiovascular injury and is caused by intermittent hypoxia and elevation of circulating catecholamines. Few studies on OSA have been performed in children. Aim: To study the 24-hours monitored blood pressure in children with OSA to identify the presence of the nocturnal physiologic drop in blood pressure and peaks of hypertension during diurnal and nocturnal period. Methods: OSA children, both genders, aged 8 to 12 years, underwent 24hours blood pressure monitoring. Children with known cardiopaty, hypertension, neurologic disorders or using sympathetic medication were excluded. The monitoring detected physiologic nocturnal drop in blood pressure and hypertension peaks during the day or night. Results: Twenty-four children were included, 18 were male, and the median age was 11 years. Eight children did not show physiologic nocturnal drop in blood pressure, and 4 children showed hypertensive peaks during the night. Conclusion: OSA in children seems to be associated with loss of nocturnal physiologic drop in blood pressure as well as development of hypertension or other cardiovascular diseases. Otolaryngologist and pediatricians must be aware of these conditions to improve diagnosis and prevention of OSA in children.
302
QUALITY OF LIFE IN ELDERLY PATIENTS WITH OBSTRUCTIVE SLEEP APNEA SYNDROME (OSAS)
F.T. Yagihara, L.M. Lucchesi, S. Tufik, L.R.A. Bittencourt. UNIFESP Introduction: There is an increased prevalence of OSAS in individuals around 55 years of age. In patients who are older than 65, on the other hand, there is an increased prevalence of apnea-hypopnea index (AHI) greater than 15/hour. In addition to the resulting sleep impairment, OSAS has an independent impact on other aspects of the quality of life in adults, and CPAP can have a substantial impact on this issue. However, studies on OSAS in the aging population are scarce. Methods: The study population included male volunteers who were older than 60 years, had a BMI lower than 35 kg/m2 , and had a clinical and polysomnographic diagnosis of OSAS as well as healthy control individuals. Both groups were submitted to an initial evaluation that consisted of a clinical examination and a quality of life questionnaire (SF-36). The OSAS group was then allocated to treatment with CPAP for at least six months, while the control group received no intervention. After this period, both groups answered the same quality of life questionnaire. Results: Twenty-nine patients with OSAS and twenty-seven age-matched controls (66.5±0.7 vs. 66.5±0.7, respectively; p=NS) were compared. The median ± SD of the AHI was 42±16.5 in the OSAS group and 5.3±3 in control group (p<0.001). The initial comparison between the two groups showed a significant difference, with worse quality of life scores in the OSAS patients in domains, such as physical functioning (PF) (p=0.01), role limitations due to physical health problems (RLDPH) (p=0.03) and bodily pain (BP) (p=0.01). However, there were no intragroup differences for the OSAS patients before and after CPAP, except for BP. In fact, there was an increase in BP scores after treatment compared to baseline (65±29 vs. 77.5±23; p<0.001). Conclusion: We observed impairments in elderly patients with OSAS with respect to various domains that affect quality of life. After CPAP treatment,
S82
Abstracts of 3rd International Congress of the Association of Sleep Medicine (WASM) / Sleep Medicine 10, Suppl. 2 (2009) S1–S83
there was an improvement in the domain of bodily pain. This finding could be explained by the association of OSAS with the inflammatory processes that cause pain, which can be reversed with treatment. Support: AFIP, FAPESP (2007/06232-0), CNPq
303
PERIPHERAL VASOCONSTRICTION AND NOCTURNAL BLOOD PRESSURE CONTROL IN HYPERTENSIVE SLEEP APNEA PATIENTS
D. Zou 1 , L. Grote 1 , D.N. Eder 1 , J. Radlinski 2 , Y. Peker 3 , J. Hedner 1 . 1 Sleep Laboratory, Department of Pulmonary Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden; 2 Department of Pathophysiology of Respiratory System, Institute for Tuberculosis and Lung Diseases Rabka-Zdrój Branch, Rabka-Zdrój, Poland; 3 Sleep Medicine Unit, Department of Neurology and Rehabilitation Medicine, Skaraborg Hospital, Skövde, Sweden Objective: Pulse wave attenuation that occurs in association with obstructive sleep apnea (OSA) is sympathetically mediated. Doxazosin (DO) is a peripheral α-receptor inhibitor, and Enalapril (EN) is an ACE inhibitor. The aim of this study was to compare the effects of DO and EN on digital vasoconstriction and nocturnal blood pressure (BP) control in hypertensive OSA patients. Methods: A double-blind crossover study on DO (4 mg/day for 2 weeks, followed by 8 mg/day for an additional 2 weeks) and EN (10 mg/day and 20 mg/day, respectively) was undertaken in 14 OSA patients with hypertension. The patients had a mean age of 55±7 years and a mean body mass index of 30.1±3.8 kg/m2 . The patient assessment, which was performed at the end of each treatment period, included ambulatory 24-hour BP, a full-night polysomnography with simultaneous peripheral arterial tonometry (PAT) and beat-to-beat finger BP monitoring (Finapres). Nighttime BP and digital vasoconstrictions, which are associated with apneic events and are measured by the PAT ratio, were analyzed. Results: There was no difference between the two treatments for either the 24-hour BP profile or the severity of OSA. There was, however, a significant difference between the DO and EN treatments with respect to the nighttime beat-to-beat finger BP (systolic BP 129±13 vs. 119±23 mmHg, P=0.02; diastolic BP 81±12 vs. 74±14 mmHg, P=0.04). In a linear mixed effects regression model, the PAT ratio increased 8.3% after treatment with DO compared to treatment with EN (P<0.0001). Each percentage of SaO2 desaturation and each second of apnea length were associated with a 0.7% and 0.3% decrease in the PAT ratio, respectively (P<0.0001). REM sleep was associated with a 2.7% increase in the PAT ratio in contrast to that of NREM sleep. Conclusion: Digital vasoconstriction that is associated with apneic events is α-receptor mediated. DO appear to have a proportionally worse effect on nocturnal BP control when compared with that of EN in hypertensive OSA patients.
Treatment Outcome Clinical Trial Research
304
A RANDOMIZED, DOUBLE-BLIND, 6-WEEK, DOSE-RANGING STUDY OF PREGABALIN IN SUBJECTS WITH RESTLESS LEGS SYNDROME
R. Allen 1 , C. Chen 2 , A. Soaita 2 , C. Wohlberg 3 , L. Knapp 2 , D. Garcia-Borreguero 4, J. Miceli 2 . 1 Johns Hopkins Department of Neurology, Baltimore, MD, USA; 2 Pfizer Global Research and Development, New London, CT, USA; 3 Pfizer Global Research and Development, New York, NY, USA; 4 Sleep Research Institute, University of Madrid, Madrid, Spain Introduction: Clinical data suggest pregabalin as a potential treatment for primary restless legs syndrome (RLS). Objectives: To characterize the dose-response relationship of pregabalin with respect to both efficacy and safety, in patients with idiopathic RLS. Methods: This was a 6-week, randomized, double-blind, placebo-controlled, dose-ranging study of pregabalin in adults with moderate to severe idiopathic RLS. Eligible patients were randomly assigned a fixed-dose pregabalin 50, 100, 150, 300, and 450 mg/day or a placebo. Assessments were conducted at baseline and in weeks 1, 2, 4, and 6. The primary endpoint was change from baseline to week 6 in the International Restless Legs Syndrome Scale
(IRLS) total score. Secondary endpoints included Clinical Global Impressions - Improvement Scale (CGI-I) responders, sleep assessments, other global and quality of life assessments and safety/tolerability. Results: A total of 137 patients participated in the study, randomly distributed into 6 similar-sized groups. At baseline, mean (SD) IRLS total scores for placebo, 50, 100, 150, 300, and 450 mg/day pregabalin groups were 23.8 (7.2), 24.6 (6.7), 25.3 (6.4), 26.2 (7.4), 25.0 (7.4), and 24.1 (7.8), respectively; the least square mean (SE; P value) differences in change from baseline to week 6 in IRLS total score (pregabalin vs. placebo) were -4.1 (2.5; P=0.0983), -4.0 (2.4; P=0.0966), -8.3 (2.5; P=0.0013), -5.2 (2.4; P=0.0353), and -8.5 (2.5; P=0.0006), respectively. From the dose-response analysis, a pregabalin dose of 123.9 mg/day was estimated to produce a 90% maximal effect in reducing RLS symptoms. Predicted mean changes from baseline to week 6 in IRLS scores using a dose response E-max model indicated that pregabalin doses of 100 to 450 mg/day corresponded to at least an average 13.6 point-reduction (at least an average 6-point placebo-corrected treatment difference). The percentage of CGI-I responders was numerically greater among patients who received pregabalin 300 or 450 mg/day compared with patients receiving placebo or lower doses of pregabalin at the last observation. The most common adverse events were dizziness, somnolence, fatigue, dry mouth and headache. Conclusions: This dose-ranging study showed that pregabalin reduced RLS symptoms in a dose-related manner with doses >150 mg/day providing significant symptom reduction. Pregabalin was safe and well tolerated across the entire dosing range. Support: Funded by Pfizer Inc.
305
EVALUATION OF A LOW-COST ORAL APPLIANCE: A PILOT STUDY
J.J. Cervo 1 , R.C. Langien 1 , S.C. Fagondes 2 , S.W. Samuel 1 , M.L. Grossi 3 , S.S. Menna Barreto 2 . 1 UFRGS; 2 HCPA; 3 PUCRS Introduction: Oral appliances (OA) are recommended for primary snoring and for patients with mild to moderate obstructive sleep apnea (OSA). They do have some advantages over CPAP treatment such as improved comfort and lower costs. OSA is an increasing public health problem, thus, concerns about the economical aspects of its treatment are very important, especially in Brazil, a developing country. The purpose of this study was to investigate the efficacy of a modified monobloc OA made with inexpensive materials for the treatment of patients with mild to moderate OSA, for further investigation. Methods: Five male patients with BMI less than 30 kg/m2 and an apnea/hypopnea index (AHI) less than 30 events/h according to the baseline polysomnography (PSG) were treated with a low-cost modified monobloc OA. They used the OA during a mean period of 86,8±4,21 nights. A second PSG was performed with patients using the OA. The following variables were evaluated: AHI, average oxygen saturation (SpO2), minimum SpO2 (nadir SpO2) and subjective daytime sleepiness evaluation (Epworth Sleepiness Scale). Results: The mean BMI was 28,6±0,39 kg/m2 and mean age was 51,8 years old (range 46 to 60 years old). PSG showed statistically significant mean reduction of 83,5%, from baseline AIH (11,26±4,12 events/h) to AHI with OA (2,31±2,23 events/h). Nadir SpO2 increased from 86±3,4 to 90,4±1,3, with a mean increase of 4,87%. The average SpO2 did not change for the two groups. There was a mean reduction of one point in the Epworth Sleepiness Scale (Signal Test, p<0,05). No clinical complication was noticed in any participant, on teeth or soft tissues. Conclusion: This easy assembly and low-cost modified model of OA improved the outcomes and presented no complications in a small group of OSA patients and may be an appropriate alternative to be used in a larger investigation.
306
THE INFLUENCE OF TREATMENT BY CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) ON HEART FUNCTION
M. Hobzova 1 , E. Sovova 2 , M. Sova 3 , K. Langova 4 , V. Kolek 1 . 1 Dept. of Pneumology, University Hospital Palacky University, Olomouc, Czech Republic; 2 I. Internal Dept., University Hospital Palacky University, Olomouc, Czech Republic; 3 Fac. of medicine and Dentistry, Palacky University, Olomouc, Czech Rep; 4 Dept. of Medical Biophysics, Palacky University, Olomouc, Czech Republic Objectives: The aim of the study was to evaluate the effects of CPAP treat-