Sleep Apnea in Multiple Sclerosis Positive Airway Pressure Trial

NCT01746342 | Completed

• 1 other identifier: MSSC-G004
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea-hypopnea in Multiple Sclerosis Patients

Outcome Measures

Primary Outcomes (1)

• Fatigue Severity Scale

  Six months

Secondary Outcomes (11)

• Fatigue Scale for Motor and Cognitive Functions

  Three & Six months

• 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

Study Arms (2)

Effective CPAP

ACTIVE COMPARATOR

Continuous positive airway pressure: effective fixed level determined by polysomnographic titration

Device: Effective continuous positive airway pressure (CPAP)

Sham CPAP

SHAM COMPARATOR

Continuous positive airway pressure device modified by manufacturer to deliver minimal pressure

Device: Sham continuous positive airway pressure (CPAP)

Interventions

Effective continuous positive airway pressure (CPAP) DEVICE

Effective CPAP

Sham continuous positive airway pressure (CPAP) DEVICE

Sham CPAP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University: lead
• Multiple Sclerosis Society of Canada (Primary funding agency): collaborator
• Centre hospitalier de l'Université de Montréal (CHUM): collaborator
• Philips Respironics: collaborator
• VitalAire Incorporated (Respiratory Therapist time): collaborator

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H3A 1A1, Canada

Location

Related Publications (1)

• 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.

  PMID: 33890515 DERIVED

Study Officials

• John Kimoff, MD

  McGill University

  PRINCIPAL INVESTIGATOR

• Daria Trojan, MD

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Principal Investigator: with Dr Daria Trojan

Study Record Dates

• First Submitted: December 6, 2012
• First Posted: December 10, 2012
• Study Start: February 1, 2013
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2018
• Last Updated: January 11, 2019

Record last verified: 2019-01

Locations

CA (1)