A Randomized, Controlled, Clinical Trial of Continuous Positive Airway Pressure Treatment of Obstructive Sleep Apnea-Hypopnea in Multiple Sclerosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- McGill University
- Enrollment
- 49
- Locations
- 2
- Primary Endpoint
- Fatigue Severity Scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Effective CPAP
Continuous positive airway pressure: effective fixed level determined by polysomnographic titration
Intervention: Effective continuous positive airway pressure (CPAP) (Device)
Sham CPAP
Continuous positive airway pressure device modified by manufacturer to deliver minimal pressure
Intervention: Sham continuous positive airway pressure (CPAP) (Device)
Outcomes
Primary Outcomes
Fatigue Severity Scale
Time Frame: Six months
Secondary Outcomes
- 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)
- Objective CPAP compliance(Three and Six Months)
- Center for Epidemiological Studies-Depression Scale(Three & Six months)
- Epworth Sleepiness Scale(Three & Six months)
- Pittsburgh Sleep Quality Index(Three & Six months)
- Cognitive evaluation(Six months)
- Polysomnographic variables(Six months)
- Fatigue Scale for Motor and Cognitive Functions(Three & Six months)
- Fatigue Severity Scale(Three months)
Investigators
Dr John Kimoff
Co-Principal Investigator: with Dr Daria Trojan
McGill University