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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by McGill University
Sponsor:
Collaborators:
Multiple Sclerosis Society of Canada (Primary funding agency)
Centre Hospitalier de l'Université de Montréal (second study site)
Philips-Respironics (CPAP equipment)
VitalAire Incorporated (Respiratory Therapist time)
Information provided by (Responsible Party):
Dr John Kimoff, McGill University
ClinicalTrials.gov Identifier:
NCT01746342
First received: December 6, 2012
Last updated: March 3, 2013
Last verified: March 2013
  Purpose

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 Intervention
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
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by McGill University:

Primary Outcome Measures:
  • Fatigue Severity Scale [ Time Frame: Six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fatigue Scale for Motor and Cognitive Functions [ Time Frame: Three & Six months ] [ Designated as safety issue: No ]
  • Epworth Sleepiness Scale [ Time Frame: Three & Six months ] [ Designated as safety issue: No ]
  • Pittsburgh Sleep Quality Index [ Time Frame: Three & Six months ] [ Designated as safety issue: No ]
  • Pain visual analog scale [ Time Frame: Three & Six months ] [ Designated as safety issue: No ]
  • Multiple Sclerosis-specific quality of life measure-54 (MSQOL-54) [ Time Frame: Three & Six months ] [ Designated as safety issue: No ]
  • Fatigue Severity Scale [ Time Frame: Three months ] [ Designated as safety issue: No ]
    Primary outcome measure is FSS at six months

  • Expanded Disability Status Scale [ Time Frame: Three & Six months ] [ Designated as safety issue: No ]
    Standard scale for evaluation of Multiple Sclerosis-related disease disability

  • Center for Epidemiological Studies-Depression Scale [ Time Frame: Three & Six months ] [ Designated as safety issue: No ]
  • Cognitive evaluation [ Time Frame: Six months ] [ Designated as safety issue: No ]
    Montreal Cognitive Assessment (MoCA) and Tower of London-Drexel University

  • Polysomnographic variables [ Time Frame: Six months ] [ Designated as safety issue: No ]
    Standard complete polysomnographic measures of sleep and respiration

  • Objective CPAP compliance [ Time Frame: Three and Six Months ] [ Designated as safety issue: No ]
    Standard measures of CPAP use and efficacy from machine microprocessor


Estimated Enrollment: 65
Study Start Date: February 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01746342

Contacts
Contact: John Kimoff, MD 514-934-1934 ext 36177 john.kimoff@mcgill.ca
Contact: Daria Trojan, MD 514-398-8911 daria.trojan@mcgill.ca

Locations
Canada, Quebec
McGill University Health Centre Recruiting
Montreal, Quebec, Canada, H3A 1A1
Contact: John Kimoff, MD    514-934-1934 ext 36117    john.kimoff@mcgill.ca   
Contact: Daria Trojan, MD    514-398-8911    daria.trojan@mcgill.ca   
Sponsors and Collaborators
McGill University
Multiple Sclerosis Society of Canada (Primary funding agency)
Centre Hospitalier de l'Université de Montréal (second study site)
Philips-Respironics (CPAP equipment)
VitalAire Incorporated (Respiratory Therapist time)
Investigators
Principal Investigator: John Kimoff, MD McGill University
Principal Investigator: Daria Trojan, MD McGill University
  More Information

No publications provided

Responsible Party: Dr John Kimoff, Co-Principal Investigator: with Dr Daria Trojan, McGill University
ClinicalTrials.gov Identifier: NCT01746342     History of Changes
Other Study ID Numbers: MSSC-G004
Study First Received: December 6, 2012
Last Updated: March 3, 2013
Health Authority: Canada: Institutional Review Board
Canada: Health Canada

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

ClinicalTrials.gov processed this record on September 22, 2014