Obstructive Sleep Apnea-hypopnea in Multiple Sclerosis PatientsSAMSPAPNCT01746342
Sleep Apnea in Multiple Sclerosis Positive Airway Pressure Trial
A study testing Effective continuous positive airway pressure (CPAP) in people with Obstructive Sleep Apnea-hypopnea in Multiple Sclerosis Patients, run by McGill University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea-hypopnea in Multiple Sclerosis Patients
- What is being tested?
- Effective continuous positive airway pressure (CPAP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2013to 30 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Controlled, Clinical Trial of Continuous Positive Airway Pressure Treatment of Obstructive Sleep Apnea-Hypopnea in Multiple Sclerosis
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.
- Being tested
- Effective continuous positive airway pressure (CPAP), Sham continuous positive airway pressure (CPAP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effective continuous positive airway pressure (CPAP)Device
Sham continuous positive airway pressure (CPAP)Device
| Study group | Role | What they receive |
|---|---|---|
| Effective CPAP | Active comparator | Continuous positive airway pressure: effective fixed level determined by polysomnographic titration Receives: Device: Effective continuous positive airway pressure (CPAP) |
| Sham CPAP | Sham comparator | Continuous positive airway pressure device modified by manufacturer to deliver minimal pressure Receives: Device: Sham continuous positive airway pressure (CPAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Severity Scale
Measured: Six months
Secondary outcomes (11)
Fatigue Scale for Motor and Cognitive Functions
Measured: Three & Six months
Epworth Sleepiness Scale
Measured: Three & Six months
Pittsburgh Sleep Quality Index
Measured: Three & Six months
Pain visual analog scale
Measured: Three & Six months
Multiple Sclerosis-specific quality of life measure-54 (MSQOL-54)
Measured: Three & Six months
Fatigue Severity Scale
Primary outcome measure is FSS at six months
Measured: Three months
Expanded Disability Status Scale
Standard scale for evaluation of Multiple Sclerosis-related disease disability
Measured: Three & Six months
Center for Epidemiological Studies-Depression Scale
Measured: Three & Six months
Cognitive evaluation
Montreal Cognitive Assessment (MoCA) and Tower of London-Drexel University
Measured: Six months
Polysomnographic variables
Standard complete polysomnographic measures of sleep and respiration
Measured: Six months
Objective CPAP compliance
Standard measures of CPAP use and efficacy from machine microprocessor
Measured: Three and Six Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study startFeb 2013
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea-hypopnea in Multiple Sclerosis PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- Multiple Sclerosis Society of Canada (Primary funding agency), Centre hospitalier de l'Université de Montréal (CHUM), Philips Respironics, VitalAire Incorporated (Respiratory Therapist time)
- Responsible party
- Principal investigator, Dr John Kimoff, McGill University
- Investigators
- John Kimoff, MD, Principal investigator, McGill UniversityDaria Trojan, MD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01746342
- Sponsor's protocol ID
- MSSC-G004
- Acronym
- SAMSPAP
- Status last verified
- Jan 2019
- First submitted
- 6 Dec 2012
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33890515
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Clinical Trial of Continuous Positive Airway Pressure Treatment of Obstructive Sleep Apnea-Hypopnea in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01746342
- Acronym / sponsor ID
- SAMSPAP / MSSC-G004
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- Multiple Sclerosis Society of Canada (Primary funding agency), Centre hospitalier de l'Université de Montréal (CHUM), Philips Respironics, VitalAire Incorporated (Respiratory Therapist time)
- Study start
- Feb 2013
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 10 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Effective CPAP | Active comparator | Device: Effective continuous positive airway pressure (CPAP)Continuous positive airway pressure: effective fixed level determined by polysomnographic titration |
| Sham CPAP | Sham comparator | Device: Sham continuous positive airway pressure (CPAP)Continuous positive airway pressure device modified by manufacturer to deliver minimal pressure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Effective continuous positive airway pressure (CPAP) | Device | Effective CPAP |
| Sham continuous positive airway pressure (CPAP) | Device | Sham CPAP |
Primary outcome
Fatigue Severity Scale
Time frame: Six months
11 secondary outcomes
Fatigue Scale for Motor and Cognitive Functions
Time frame: Three & Six months
Epworth Sleepiness Scale
Time frame: Three & Six months
Pittsburgh Sleep Quality Index
Time frame: Three & Six months
Pain visual analog scale
Time frame: Three & Six months
Multiple Sclerosis-specific quality of life measure-54 (MSQOL-54)
Time frame: Three & Six months
Fatigue Severity Scale
Time frame: Three months
Expanded Disability Status Scale
Time frame: Three & Six months
Center for Epidemiological Studies-Depression Scale
Time frame: Three & Six months
Cognitive evaluation
Time frame: Six months
Polysomnographic variables
Time frame: Six months
Objective CPAP compliance
Time frame: Three and Six Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
- Derived from this study: PubMed 33890515Khadadah 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Kimoff, MD principal investigator
McGill University
Daria Trojan, MD principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Effective continuous positive airway pressure (CPAP) in people with Obstructive Sleep Apnea-hypopnea in Multiple Sclerosis Patients, run by McGill University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Severity Scale (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01746342, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2019.