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Completed

NCT Number: NCT01746342

Sleep Apnea in Multiple Sclerosis Positive Airway Pressure Trial

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.

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Key information

Conditions

Obstructive Sleep Apnea-hypopnea in Multiple Sclerosis Patients

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McGill University Health Centre

Montreal, Quebec, H3A 1A1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Effective continuous positive airway pressure (CPAP)

Device

Sham continuous positive airway pressure (CPAP)

Device

Primary outcomes

  1. Fatigue Severity Scale

    Time frame: Six months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

McGill University

Other

Collaborators

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

Registry information

Official study title

A Randomized, Controlled, Clinical Trial of Continuous Positive Airway Pressure Treatment of Obstructive Sleep Apnea-Hypopnea in Multiple Sclerosis

Acronym: SAMSPAP

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Dec 10, 2012
Registry last updated
Jan 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.