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)

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) pa...

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Published in:Multiple sclerosis 2022-01, Vol.28 (1), p.82-92
Main Authors: Khadadah, Sulaiman, Kimoff, R John, Duquette, Pierre, Jobin, Vincent, Lapierre, Yves, Benedetti, Andrea, Johara, Fatema T, Robinson, Ann, Roger, Elaine, Bar-Or, Amit, Leonard, Gabriel, Kaminska, Marta, Trojan, Daria A
Format: Article
Language:English
Subjects:
Apnea
Continuous Positive Airway Pressure
Double-blind studies
Fatigue
Humans
Multiple sclerosis
Multiple Sclerosis - complications
Multiple Sclerosis - therapy
Original Research Papers
Patients
Quality of Life
Respiratory tract
Sleep
Sleep and wakefulness
Sleep apnea
Sleep Apnea, Obstructive - therapy
Sleep deprivation
Sleep disorders
Sleep Quality
Treatment Outcome
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Summary: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.
ISSN:1352-4585
1477-0970
DOI:10.1177/13524585211010390