Sleep Apnea in Multiple Sclerosis Positive Airway Pressur... | NCT01746342

Studies
Sleep Apnea in Multiple Sclerosis Positive Airway Pressure Trial

NCT01746342

Sponsor

McGill University

Status

Completed

Last Update Posted

Jan 11, 2019Actual

Enrollment

49Actual

Phase

Not Applicable

Conditions

Obstructive Sleep Apnea-hypopnea in Multiple Sclerosis Patients

Interventions

Effective continuous positive airway pressure (CPAP)
Sham continuous positive airway pressure (CPAP)

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2013

Primary Completion Date

Nov 30, 2018Actual

Completion Date

Nov 30, 2018Actual

First Submitted Date

Dec 6, 2012

First Submission Date that Met QC Criteria

Dec 7, 2012

First Posted Date

Dec 10, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2019

Last Update Posted Date

Jan 11, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr John Kimoff, Co-Principal Investigator: with Dr Daria Trojan, McGill UniversityPrincipal Investigator

Lead Sponsor

McGill UniversityOTHER

Collaborators

Name	Class
Multiple Sclerosis Society of Canada (Primary funding agency)	UNKNOWN
Centre hospitalier de l'Université de Montréal (CHUM)	OTHER
Philips Respironics	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

49Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Effective continuous positive airway pressure (CPAP)	Device		Effective CPAP
Sham continuous positive airway pressure (CPAP)

Measure	Description	Time Frame
Fatigue Severity Scale		Six months

Measure	Description	Time Frame
Fatigue Scale for Motor and Cognitive Functions		Three & Six months
Epworth Sleepiness Scale		Three & Six months
Pittsburgh Sleep Quality Index

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John Kimoff, MD	McGill University	Principal Investigator
Daria Trojan, MD	McGill University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
McGill University Health Centre		Montreal	Quebec	H3A 1A1	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33890515	Derived	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.