1. Effect of continuous positive airway pressure treatment of obstructive sleep apnea-hypopnea in multiple sclerosis: A randomized, double-blind, placebo-controlled trial (SAMS-PAP study)
- Author
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Marta Kaminska, Daria A Trojan, A Robinson, Elaine Roger, Vincent Jobin, Pierre Duquette, Sulaiman Khadadah, Y Lapierre, R. John Kimoff, Gabriel Leonard, Andrea Benedetti, Amit Bar-Or, and Fatema T Johara
- Subjects
Multiple Sclerosis ,medicine.medical_treatment ,Placebo-controlled study ,sleepiness ,Double blind ,03 medical and health sciences ,0302 clinical medicine ,Humans ,Medicine ,Continuous positive airway pressure ,sleep ,obstructive ,Sleep Apnea, Obstructive ,Continuous Positive Airway Pressure ,business.industry ,Multiple sclerosis ,Sleep apnea ,clinical trial ,sleep apnea ,medicine.disease ,nervous system diseases ,respiratory tract diseases ,Clinical trial ,Obstructive sleep apnea ,Sleep Quality ,Treatment Outcome ,030228 respiratory system ,Neurology ,Anesthesia ,Quality of Life ,fatigue ,Neurology (clinical) ,business ,Original Research Papers ,Hypopnea ,030217 neurology & neurosurgery - Abstract
Objective: The aim of this study was to evaluate the effect of continuous positive airway pressure (CPAP) treatment on the Fatigue Severity Scale (FSS, preplanned primary outcome), another fatigue measure, sleep quality, somnolence, pain, disability, and quality of life in multiple sclerosis (MS) patients with obstructive sleep apnea-hypopnea (OSAH). Methods: In a randomized, double-blind trial (NCT01746342), MS patients with fatigue, poor subjective sleep quality, and OSAH (apnea-hypopnea index of ⩾ 15 events per hour/sleep), but without severe OSAH (apnea-hypopnea index > 30, and 4% oxygen desaturation index > 15 events/hour or severe somnolence), were randomized to fixed CPAP or sham CPAP for 6 months. Outcome assessments were performed at 3 and 6 months. Results: Of 49 randomized patients, 34 completed the protocol. Among completers, FSS did not improve with CPAP compared to sham at 6 months. FSS tended to improve ( p = 0.09), and sleepiness (Epworth Sleepiness Scale) improved significantly ( p = 0.03) at 3 months with CPAP compared to sham, but there were no other improvements with CPAP at either study evaluation. Conclusion: In non-severe OSAH patients, CPAP did not significantly improve the primary outcome of FSS change at 6 months. In secondary analyses, we found a trend to improved FSS, and a significant reduction in somnolence with CPAP at 3 months.
- Published
- 2021
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