Oral Platform Presentations / Sleep Medicine 8 Suppl. 1 (2007) S49–S66 O0044 On the definition of response, non-response and relapse to drug treatment in restless legs syndrome R. Kohnen1,2 , H. Benes3 , C. Meissner3 , R. Benecke2 . 1 IMEREM GmbH, Nuremberg, Germany, 2 Neurology Department, University of Rostock, Rostock, Germany, 3 Somni bene GmbH, Schwerin, Germany Introduction: Several drug treatments for Restless Legs Syndrome (RLS) have been evaluated in clinical trials during the recent years, using mean changes from baseline. Especially in the context of augmentation and tolerance, but also to evaluate clinical relevance of drug-induced changes in outcome measures, a need for definition of qualitative treatment outcome is recognized. Based on IRLS data (International RLS Severity Scale) we propose the following categories: • Non-response (NR): condition unchanged or worsened compared to baseline; • Minimal improvement (MI): change >0% and <20%; • Moderate improvement (MO): change >20% and <50%); • Definite response (RS): change >50% and <100%; • Remitter (R0): change 100%, symptom-free or IRLS total score <10 • Relapse (R10): worsening by at least 2 categories or NR during longterm therapy (e.g., after 3 months) compared to an at least moderate initial response (e.g., after 4 weeks). Methods: IRLS data from a double-blind, multi-center dose-finding study comparing 3 doses of the dopamine agonist lisuride in its transdermal application (1, 2, or 4 mg/24 h lisuride) and placebo during a 12-week treatment period in 210 severely disabled RLS patients. Results: There was a clear dose–response relationship in the categories RS, R10, and R0 with increasing rates of patients with increasing dose. NR and MI occurred most frequently in the placebo group; in category MO, also the lowest lisuride dose was frequently present, indicating that efficacy was not sufficient to treat severely disabled RLS patients in this group. Under all lisuride treated patients, 7% fulfilled the criteria for relapse compared to 10% under placebo. Conclusions: Our classification should harmonize qualitative outcome research in RLS treatments. The response categories demonstrate the clinical relevance of treatment efficacy, analysis of non-response or poor efficacy is not yet addressed. The relapse definition might help to identify patients with augmentation and tolerance. O0045 Sleep related sweating in OSA patients: cardiovascular risk and sleepiness E.S. Arnardottir1 *, B. Thorleifsdottir2 , E. Svanborg3 , I. Olafsson4 , T. Gislason1 . 1 Department of Allergy, Respiratory Medicine and Sleep, Landspitali University Hospital, Reykjavik, Iceland, 2 Institute of Physiology, University of Iceland, Reykjavik, Iceland, 3 Department of Clinical Neurophysiology, University Hospital, Link¨oping, Sweden, 4 Department of Clinical Biochemistry, Landspitali University Hospital, Reykjavik, Iceland Introduction: Sleep related sweating is a common complaint among patients with obstructive sleep apnea (OSA); often disappearing with successful continuous positive airway pressure (CPAP) treatment. However few studies have focused on this symptom of OSA. We report preliminary data from an ongoing study on sleep related sweating before and after CPAP treatment. Methods: Patients underwent full polysomnography including measurements of electrodermal activity (EDA) for monitoring of sweating. Data evaluation was done in a standard manner, i.e., sleep scoring and apnea– hypopnea index (AHI) calculation. EDA index (events/hour sleep) was assessed, considering an EDA event a change in skin potential of >50 mV amplitude and >1.5 s duration. Evening and morning blood samples were collected for analysis of high-sensitivity C-reactive protein (hs-CRP). Results: Ten otherwise healthy male OSA patients (mean age ± SD 49.3±10.3 years) were studied before and again after 3 months on CPAP treatment. Their mean AHI decreased from 41.6±11.3 to 3.5±2.8 with treatment. Among 8 OSAS patients, the EDA index was significantly lower on CPAP treatment (decreased from 123±94 to 37±44, p = 0.003) but in 2 patients the EDA index increased (from 88±46 to 185±30). Decrease in diastolic blood pressure on CPAP treatment was strongly correlated with a decrease in EDA index (r = 0.86, p = 0.001 and r = 0.62, p = 0.06 for
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evening and morning blood pressure values, respectively). Similarly there was a concomitant decrease in EDA index and hs-CRP on CPAP treatment (r = 0.69, p = 0.04). There were altogether 3 patients who still had an EDA index above 100 on CPAP therapy. These 3 were the only patients who still reported excessive daytime sleepiness; Epworth Sleepiness score 10, 12 and 14 respectively. Conclusion: These results indicate that sleep related sweating is associated with cardiovascular risk profile in OSA patients. Further, sleep related sweating is strongly associated with reported daytime sleepiness, possibly reflecting autonomic arousals during sleep. Contributed support: Public grants: Science Fund of LandspitaliUniversity Hospital, The Icelandic Research Fund and the Icelandic Graduate Research Fund. O0046 Abnormal sleep–wake cycles in patients with tuberculous meningitis – a prospective case controlled study V. Pardasani *, G. Shukla, S. Singh, V. Goyal, M. Behari. Department of Neurology, All India Institute of Medical Sciences, New Delhi-110029, India Background: Patients with tuberculous meningitis (TBM) have been frequently observed to have excessive sleep during the day and frequent awakenings during night. We undertook this study to evaluate sleep related abnormalities in patients with TBM since there is no published literature pertaining to the same. Methods: Consecutive patients admitted with tuberculous meningitis were studied clinically and with three days of continuous wrist actigraphy and sleep/wake parameters were compared to those of age and gender matched normal healthy controls. Results: Twenty-eight patients (15F, 13M; mean age 31.64 years) and an equal number of controls (15F, 13M; mean age 30.93 years) were enrolled. Patients were found to have greater sleep time (p < 0.0005) and more sleep episodes (p < 0.0005) during the day while during the night they had less sleep (p < 0.0005) with more frequent (p = 0.019) and longer (p < 0.0005) awakenings as compared to normal controls. Conclusions: Tuberculous meningitis is associated with significant alteration of sleep–wake circadian cycles. This needs to be further characterized through studies involving polysomnography. There is a need to address these specific sleep difficulties to improve the quality of life of the patient as well as the care-giver. O0047 Sleep laboratory characteristics of patients with restless legs syndrome augmentation D. Garcia-Borreguero, R. Egatz, O. Larrosa. Sleep Research Institute, Madrid, Spain Background: The objective of this study was to investigate polysomnographic characteristics of Restless Legs Syndrome (RLS) patients undergoing augmentation during long-term L-DOPA treatment. Design: Thirty previously untreated patients with idiopathic RLS were treated for 12−18 months (mean: 16.4 months) with a mean dose of 240 mg/day L-DOPA. Severity of symptoms was evaluated before and every two months during treatment by means of the International RLS scale (IRLS)1. A blind rater evaluated patients every two months regarding augmentation. Patients underwent before and after treatment a suggested immobilization test (SIT) followed by an all-night polysomnographic study. Results: (a) Clinical: The sample included 30 patients (seventeen women), with a mean age of 55.1 years (+5.2 y). IRLS score improved in the overall group from 25.6(+3.2) to 11.1(+7.6) points at the end of treatment. 14 patients were classified as presenting AUG, while 16 had no AUG. (b) Polysomnography: At baseline, AUG presented a higher index of Periodic Leg Movement of Sleep (PLMS) (37.6+7.3 vs. 23.2+5.7) or of Wakefulness (PLMW) than N-AUG (both p < 0.05). Further, AUG presented a marginally higher sleep latency (p = 0.06) and percentage of stage 1 sleep (p = 0.07) than N-AUG. Following treatment, AUG presented an increased index of PLMS, PLMW, PLM-arousal index, sleep latency, as well as a lower Total Sleep Time and sleep efficiency (all p < 0.05). (c) SIT: PLMW-index was higher in AUG than N-AUG, but no differences