Sleep Apnea in Multiple Sclerosis Positive Airway Pressure Trial

NCT ID: NCT01746342

Last Updated: 2019-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2018-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Effective CPAP

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

Group Type: ACTIVE_COMPARATOR

Effective continuous positive airway pressure (CPAP)

Intervention Type: DEVICE

Sham CPAP

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

Group Type: SHAM_COMPARATOR

Sham continuous positive airway pressure (CPAP)

Intervention Type: DEVICE

Interventions

Effective continuous positive airway pressure (CPAP)

Intervention Type: DEVICE

Sham continuous positive airway pressure (CPAP)

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Multiple Sclerosis Society of Canada (Primary funding agency)

UNKNOWN

Sponsor Role: collaborator

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: collaborator

Philips Respironics

INDUSTRY

Sponsor Role: collaborator

VitalAire Incorporated (Respiratory Therapist time)

UNKNOWN

Sponsor Role: collaborator

McGill University

OTHER

Sponsor Role: lead

Responsible Party

Dr John Kimoff

Co-Principal Investigator: with Dr Daria Trojan

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John Kimoff, MD

Role: PRINCIPAL_INVESTIGATOR

McGill University

Daria Trojan, MD

Role: PRINCIPAL_INVESTIGATOR

McGill University

Locations

McGill University Health Centre

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 33890515 (View on PubMed)

Other Identifiers

MSSC-G004

Identifier Type: -

Identifier Source: org_study_id