Clinical trial NCT01746342: Sleep Apnea in Multiple Sclerosis Positive Airway Pressure Trial
Official title: A Randomized, Controlled, Clinical Trial of Continuous Positive Airway Pressure Treatment of Obstructive Sleep Apnea-Hypopnea in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea-hypopnea in Multiple Sclerosis Patients
Lead sponsor: McGill University
Sponsor class: OTHER
Collaborators: name: Multiple Sclerosis Society of Canada (Primary funding agency)
name: Centre hospitalier de l'Université de Montréal (CHUM)
name: Philips Respironics
name: VitalAire Incorporated (Respiratory Therapist time)
First posted: 2012-12-10
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Fatigue Severity Scale
timeFrame: Six months
Secondary outcomes:
measure: Fatigue Scale for Motor and Cognitive Functions
timeFrame: Three & Six months
measure: Epworth Sleepiness Scale
timeFrame: Three & Six months
measure: Pittsburgh Sleep Quality Index
timeFrame: Three & Six months
measure: Pain visual analog scale
timeFrame: Three & Six months
measure: Multiple Sclerosis-specific quality of life measure-54 (MSQOL-54)
timeFrame: Three & Six months
measure: Fatigue Severity Scale
timeFrame: Three months
measure: Expanded Disability Status Scale
timeFrame: Three & Six months
measure: Center for Epidemiological Studies-Depression Scale
timeFrame: Three & Six months
measure: Cognitive evaluation
timeFrame: Six months
measure: Polysomnographic variables
timeFrame: Six months
measure: Objective CPAP compliance
timeFrame: Three and Six Months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
affiliation: McGill University
name: John Kimoff, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University
name: Daria Trojan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Khadadah S, Kimoff RJ, Duquette P, Jobin V, Lapierre Y, Benedetti A, Johara FT, Robinson A, Roger E, Bar-Or A, Leonard G, Kaminska M, Trojan DA. 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). Mult Scler. 2022 Jan;28(1):82-92. doi: 10.1177/13524585211010390. Epub 2021 Apr 23.