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Sleep Apnea in Multiple Sclerosis Positive Airway Pressure Trial

NCT01746342 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2019-01-11

No results posted yet for this study

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

Interventions

DEVICE

Effective continuous positive airway pressure (CPAP)

DEVICE

Sham continuous positive airway pressure (CPAP)

Sponsors & Collaborators

  • Multiple Sclerosis Society of Canada (Primary funding agency)

    collaborator UNKNOWN

  • Centre hospitalier de l'Université de Montréal (CHUM)

    collaborator OTHER

  • Philips Respironics

    collaborator INDUSTRY

  • VitalAire Incorporated (Respiratory Therapist time)

    collaborator UNKNOWN

  • McGill University

    lead OTHER

Principal Investigators

  • John Kimoff, MD · McGill University

  • Daria Trojan, MD · McGill University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2018-11-30
Completion
2018-11-30

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01746342 on ClinicalTrials.gov