Sleep Apnea in Multiple Sclerosis Positive Airway Pressure Trial (SAMSPAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01746342
Recruitment Status : Recruiting
First Posted : December 10, 2012
Last Update Posted : March 21, 2018
Multiple Sclerosis Society of Canada (Primary funding agency)
Centre hospitalier de l'Université de Montréal (CHUM)
Philips-Respironics (CPAP equipment)
VitalAire Incorporated (Respiratory Therapist time)
Information provided by (Responsible Party):
Dr John Kimoff, McGill University

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.

Condition or disease Intervention/treatment
Obstructive Sleep Apnea-hypopnea in Multiple Sclerosis Patients Device: Effective continuous positive airway pressure (CPAP) Device: Sham continuous positive airway pressure (CPAP)

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Clinical Trial of Continuous Positive Airway Pressure Treatment of Obstructive Sleep Apnea-Hypopnea in Multiple Sclerosis
Study Start Date : February 2013
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Effective CPAP
Continuous positive airway pressure: effective fixed level determined by polysomnographic titration
Device: Effective continuous positive airway pressure (CPAP)
Sham Comparator: Sham CPAP
Continuous positive airway pressure device modified by manufacturer to deliver minimal pressure
Device: Sham continuous positive airway pressure (CPAP)

Primary Outcome Measures :
  1. Fatigue Severity Scale [ Time Frame: Six months ]

Secondary Outcome Measures :
  1. Fatigue Scale for Motor and Cognitive Functions [ Time Frame: Three & Six months ]
  2. Epworth Sleepiness Scale [ Time Frame: Three & Six months ]
  3. Pittsburgh Sleep Quality Index [ Time Frame: Three & Six months ]
  4. Pain visual analog scale [ Time Frame: Three & Six months ]
  5. Multiple Sclerosis-specific quality of life measure-54 (MSQOL-54) [ Time Frame: Three & Six months ]
  6. Fatigue Severity Scale [ Time Frame: Three months ]
    Primary outcome measure is FSS at six months

  7. Expanded Disability Status Scale [ Time Frame: Three & Six months ]
    Standard scale for evaluation of Multiple Sclerosis-related disease disability

  8. Center for Epidemiological Studies-Depression Scale [ Time Frame: Three & Six months ]
  9. Cognitive evaluation [ Time Frame: Six months ]
    Montreal Cognitive Assessment (MoCA) and Tower of London-Drexel University

  10. Polysomnographic variables [ Time Frame: Six months ]
    Standard complete polysomnographic measures of sleep and respiration

  11. Objective CPAP compliance [ Time Frame: Three and Six Months ]
    Standard measures of CPAP use and efficacy from machine microprocessor

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01746342

Contact: John Kimoff, MD 514-934-1934 ext 36177
Contact: Daria Trojan, MD 514-398-8911

Canada, Quebec
McGill University Health Centre Recruiting
Montreal, Quebec, Canada, H3A 1A1
Contact: John Kimoff, MD    514-934-1934 ext 36117   
Contact: Daria Trojan, MD    514-398-8911   
Sponsors and Collaborators
McGill University
Multiple Sclerosis Society of Canada (Primary funding agency)
Centre hospitalier de l'Université de Montréal (CHUM)
Philips-Respironics (CPAP equipment)
VitalAire Incorporated (Respiratory Therapist time)
Principal Investigator: John Kimoff, MD McGill University
Principal Investigator: Daria Trojan, MD McGill University

Responsible Party: Dr John Kimoff, Co-Principal Investigator: with Dr Daria Trojan, McGill University Identifier: NCT01746342     History of Changes
Other Study ID Numbers: MSSC-G004
First Posted: December 10, 2012    Key Record Dates
Last Update Posted: March 21, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Multiple Sclerosis
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders