Obstructive Sleep Apnea-hypopnea in Multiple Sclerosis Patients
Conditions
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.
Interventions
DEVICEEffective continuous positive airway pressure (CPAP)
Sponsors
Multiple Sclerosis Society of Canada (Primary funding agency)
Centre hospitalier de l'Université de Montréal (CHUM)
Philips Respironics
VitalAire Incorporated (Respiratory Therapist time)
McGill University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fatigue Severity Scale | Six months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Epworth Sleepiness Scale | Three & Six months | — |
| Pittsburgh Sleep Quality Index | Three & Six months | — |
| Pain visual analog scale | Three & Six months | — |
| Multiple Sclerosis-specific quality of life measure-54 (MSQOL-54) | Three & Six months | — |
| Fatigue Severity Scale | Three months | Primary outcome measure is FSS at six months |
| Fatigue Scale for Motor and Cognitive Functions | Three & Six months | — |
| Center for Epidemiological Studies-Depression Scale | Three & Six months | — |
| Cognitive evaluation | Six months | Montreal Cognitive Assessment (MoCA) and Tower of London-Drexel University |
| 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 |
| Expanded Disability Status Scale | Three & Six months | Standard scale for evaluation of Multiple Sclerosis-related disease disability |
Countries
Canada
Outcome results
None listed