Sleep Apnea in Multiple Sclerosis Positive Airway Pressure Trial

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea-hypopnea in Multiple Sclerosis Patients
• Interventions: Device: Sham continuous positive airway pressure (CPAP); Device: Effective continuous positive airway pressure (CPAP)

• Registration Number: NCT01746342
• Lead Sponsor: McGill University

Brief Summary

Fatigue is highly prevalent among multiple sclerosis (MS) patients and has pervasive adverse effects on daily functioning and quality of life. The investigators found in a recent study that obstructive sleep apnea-hypopnea (OSAH) is the most common sleep abnormality in multiple sclerosis (MS) patients. There was also a significant relationship between OSAH and higher fatigue scores in MS patients. Preliminary work from the investigators in this group of subjects shows that treatment of sleep disorders (mostly OSAH) can improve fatigue and other symptoms in some MS patients. However, it is now necessary to systemically test the effect of OSAH treatment in a randomized, controlled study, to be sure that it really does improve fatigue and other symptoms. The best treatment for OSAH in the general population is continuous positive airway pressure (CPAP). This treatment has been well tolerated by most MS patients who have used the device at the investigators' center. This project will therefore be a randomized, controlled, clinical trial of CPAP in MS patients with OSAH. The effects of six months of CPAP treatment on fatigue as well as sleep quality, somnolence, pain, disability, and quality of life will be studied.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-06
• Study First Submitted QC: 2012-12-07
• Study First Posted: 2012-12-10
• Study Start: 2013-02
• Primary Completion: 2018-11-30
• Study Completion: 2018-11-30
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-10
• Last Update Posted: 2019-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• Diagnosis of multiple sclerosis by a neurologist based on standard criteria (Annals Neurol 2011; 69:292-302)
• Expanded Disability Status Scale score of 0 to 7.0
• MS-relapse free for >30 days prior to screening
• Pittsburgh sleep quality Index > 5
• Fatigue Severity Scale score >=4
• Montreal Cognitive Assessment (MoCA) >= 26
• diagnosis of OSAH by polysomnography showing AHI >= 15 events/h of sleep
• forced vital capacity >60% predicted

Exclusion Criteria

• pregnancy or planned pregnancy
• psychiatric conditions which could preclude compliance with informed consent, study procedures, or study requirements
• other significant neurological, pulmonary, otorhinological, and medical disorders
• major depression within the past year
• any value of >1.5 times the upper limit or <0.75 the lower limit of the reference range for any standard clinical hemogram and biochemistry determinations which is clinically significant
• current treatment for OSAH
• presence of another untreated sleep disorder which is clinically significant
• very severe OSAH (safety criterion)defined as an AHI >30 with either a 4% O2 desaturation index >15 events/h OR work in a safety-critical position OR an ESS score >=15

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham CPAP	Sham continuous positive airway pressure (CPAP)	Continuous positive airway pressure device modified by manufacturer to deliver minimal pressure
Effective CPAP	Effective continuous positive airway pressure (CPAP)	Continuous positive airway pressure: effective fixed level determined by polysomnographic titration

Primary Outcome Measures

Name	Time	Method
Fatigue Severity Scale	Six months

Secondary Outcome Measures

Name	Time	Method
Epworth Sleepiness Scale	Three & Six months
Polysomnographic variables	Six months	Standard complete polysomnographic measures of sleep and respiration
Objective CPAP compliance	Three and Six Months	Standard measures of CPAP use and efficacy from machine microprocessor
Pain visual analog scale	Three & Six months
Multiple Sclerosis-specific quality of life measure-54 (MSQOL-54)	Three & Six months
Expanded Disability Status Scale	Three & Six months	Standard scale for evaluation of Multiple Sclerosis-related disease disability
Center for Epidemiological Studies-Depression Scale	Three & Six months
Pittsburgh Sleep Quality Index	Three & Six months
Cognitive evaluation	Six months	Montreal Cognitive Assessment (MoCA) and Tower of London-Drexel University
Fatigue Scale for Motor and Cognitive Functions	Three & Six months
Fatigue Severity Scale	Three months	Primary outcome measure is FSS at six months

Trial Locations

Locations (1)

McGill University Health Centre; 🇨🇦 Montreal, Quebec, Canada