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

Primary Purpose

Obstructive Sleep Apnea-hypopnea in Multiple Sclerosis Patients

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Effective continuous positive airway pressure (CPAP)

Sham continuous positive airway pressure (CPAP)

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea-hypopnea in Multiple Sclerosis Patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

McGill University Health Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Effective CPAP

Sham CPAP

Arm Description

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

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

Outcomes

Primary Outcome Measures

Fatigue Severity Scale

Secondary Outcome Measures

Fatigue Scale for Motor and Cognitive Functions

Epworth Sleepiness Scale

Pittsburgh Sleep Quality Index

Pain visual analog scale

Multiple Sclerosis-specific quality of life measure-54 (MSQOL-54)

Fatigue Severity Scale

Primary outcome measure is FSS at six months

Expanded Disability Status Scale

Standard scale for evaluation of Multiple Sclerosis-related disease disability

Center for Epidemiological Studies-Depression Scale

Cognitive evaluation

Montreal Cognitive Assessment (MoCA) and Tower of London-Drexel University

Polysomnographic variables

Standard complete polysomnographic measures of sleep and respiration

Objective CPAP compliance

Standard measures of CPAP use and efficacy from machine microprocessor

Full Information

NCT ID

NCT01746342

First Posted

December 6, 2012

Last Updated

January 10, 2019

Sponsor

McGill University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01746342

Brief Title

Sleep Apnea in Multiple Sclerosis Positive Airway Pressure Trial

Acronym

SAMSPAP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

February 2013 (undefined)

Primary Completion Date

November 30, 2018 (Actual)

Study Completion Date

November 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

McGill University

Collaborators

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

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnea-hypopnea in Multiple Sclerosis Patients

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Effective CPAP

Arm Type

Active Comparator

Arm Description

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

Arm Title

Sham CPAP

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Effective continuous positive airway pressure (CPAP)

Intervention Type

Device

Intervention Name(s)

Sham continuous positive airway pressure (CPAP)

Primary Outcome Measure Information:

Title

Fatigue Severity Scale

Time Frame

Six months

Secondary Outcome Measure Information:

Title

Fatigue Scale for Motor and Cognitive Functions

Time Frame

Three & Six months

Title

Epworth Sleepiness Scale

Time Frame

Three & Six months

Title

Pittsburgh Sleep Quality Index

Time Frame

Three & Six months

Title

Pain visual analog scale

Time Frame

Three & Six months

Title

Multiple Sclerosis-specific quality of life measure-54 (MSQOL-54)

Time Frame

Three & Six months

Title

Fatigue Severity Scale

Description

Primary outcome measure is FSS at six months

Time Frame

Three months

Title

Expanded Disability Status Scale

Description

Standard scale for evaluation of Multiple Sclerosis-related disease disability

Time Frame

Three & Six months

Title

Center for Epidemiological Studies-Depression Scale

Time Frame

Three & Six months

Title

Cognitive evaluation

Description

Montreal Cognitive Assessment (MoCA) and Tower of London-Drexel University

Time Frame

Six months

Title

Polysomnographic variables

Description

Standard complete polysomnographic measures of sleep and respiration

Time Frame

Six months

Title

Objective CPAP compliance

Description

Standard measures of CPAP use and efficacy from machine microprocessor

Time Frame

Three and Six Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John Kimoff, MD

Organizational Affiliation

McGill University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Daria Trojan, MD

Organizational Affiliation

McGill University

Official's Role

Principal Investigator

Facility Information:

Facility Name

McGill University Health Centre

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3A 1A1

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

33890515

Citation

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.

Results Reference

derived

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Sleep Apnea in Multiple Sclerosis Positive Airway Pressure Trial

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