Spinal Cord InjuryNCT02830074

Treatment of Sleep-disordered Breathing in Patients With SCI

A study testing Best practices PAP + patient Education +ongoing Support and Training and Sleep Education in people with Spinal Cord Injury and Sleep-disordered Breathing, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Spinal Cord Injury, Sleep-disordered Breathing, Spinal Cord Disease
What is being tested?: Best practices PAP + patient Education +ongoing Support and Training and Sleep Education
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 73 participants
Where: 1 siteUnited States
Study dates: 1 May 2017to 30 Mar 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Adult patients with chronic SCI/D (>3 months post injury)
American Spinal Injury Association (ASIA) classification A-D (i.e., excluding those with no evidence of a neurologic deficit based on ASIA classification).

Who cannot join

Patients receiving mechanical ventilation
already using PAP for SDB at optimal compliance
A clinical contraindication that prevents PAP use.
recent health event that may affect sleep, e.g.:
CVA
acute MI

Show all 11Show fewer

recent surgery or hospitalization
alcohol or substance abuse (<90 days sobriety)
self-described as too ill to engage in study procedures
unable to provide self-consent for participation (e.g., due to dementia)
the investigators will offer to re-contact patients 90 days after a health event or after 90 days of sobriety

Trial locations and contacts

1 site in 1 country.

United States1 site

John D. Dingell VA Medical Center, Detroit, MI
Detroit, Michigan, 48201

Other trials in United States

About this study

Official title: Does Treatment of Sleep-Disordered Breathing Improve Functional Outcomes in SCI

Sleep-disordered breathing (SDB) remains under-treated in individuals living with spinal cord injuries and disorders (SCI/D). The investigators' aim is to test a program that addresses challenges and barriers to positive airway pressure (PAP) treatment of SDB among patients with SCI/D. The investigators anticipate that patients who receive this program will have higher rates of PAP use and will demonstrate improvements in sleep quality, general functioning, respiratory functioning and quality of life from baseline to 6 months follow up compared to individuals who receive a control program. This work addresses critical healthcare needs for patients with SCI/D and may lead to improved health and quality of life for these patients.

Read the detailed description

This proposal aims to test the efficacy of a comprehensive approach to improving positive airway pressure (PAP) therapy acceptance and adherence and sleep quality among patients with SCI/D. The proposed study is very relevant to the mission of the VA in promoting optimal health for all Veterans, including those with disabilities. To this end, this study is a randomized controlled trial (RCT) comparing the efficacy of a combined sleep and PAP adherence program, called the "BEST" program (Best practices PAP + patient Education +ongoing Support and Training). The central aim of this proposal therefore is to test the efficacy between two PAP adherence programs. The study has two main aims. First, the investigators aim to test the efficacy of the educational program in improving adherence to PAP therapy for the first 6 months of use (with data available for some subjects for up to 12 months). Second, the investigators will evaluate the impact of the program on sleep quality and on three key areas of function: general functioning (using measures specific to SCI/D patients), respiratory functioning (via spirometry) and quality of life (assessed with measures appropriate for use with patients having limited mobility) over the 3-month intervention period. The investigators will also explore whether the intervention is more effective for some subgroups of patients than others. The proposed work is very relevant to VA's patient care mission, addressing a critical need for patients who suffer from disparity in access to high quality care because of their disabilities. The investigators anticipate that the investigators' work will yield significant new knowledge that improves the health and quality of life for Veterans living with SCI/D.

Conditions: Spinal Cord Injury, Sleep-disordered Breathing, Spinal Cord Disease, Multiple Sclerosis
Being tested: Best practices PAP + patient Education +ongoing Support and Training, Sleep Education
Keywords: Sleep Apnea Syndromes, Spinal Cord Injuries, Sleep, Quality of life
Medical subject headings: Spinal Cord Injuries, Sleep Apnea Syndromes, Spinal Cord Diseases, Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Best practices PAP + patient Education +ongoing Support and TrainingBehavioural
This is a combined sleep and PAP adherence program, called the "BEST" program (Best practices PAP + Education + ongoing Support/Training
Sleep EducationBehavioural
This program includes non-directive sleep education plus standard treatment of SDB.

Study groups in NCT02830074
Study group	Role	What they receive
The BEST Program	Experimental	a combined sleep and PAP adherence program, called the BEST program (Best practices PAP + patient Education + ongoing Support and Training) Receives: Behavioral: Best practices PAP + patient Education +ongoing Support and Training
Sleep Education and standard SDB treatment	Active comparator	This program includes non-directive sleep education plus standard treatment of SDB. Receives: Behavioral: Sleep Education

What is being measured

The primary outcome is the main question the study is designed to answer.

PAP Adherence
Number of nights positive airway pressure (PAP) was used >=4 hours during the first 90 days measured by remote monitoring. Scores range from 0 to 90 days. Higher scores indicate better outcome.
Measured: 90 days
Subjective Sleep Quality Was Measured by The Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is an 18-item questionnaire that assesses sleep quality and disturbances over the past month. The PSQI is sensitive for distinguishing normal and abnormal sleepers and has good test-retest reliability. The investigators will use the 3-factor scoring, which has been shown to have superior psychometric properties. This will be used as the main independent measure of sleep quality.
The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality
Measured: 90 days

Secondary outcomes (6)

Quality of Life Was Measured by WHO-QOL BREF Questionnaire
The questionnaire is composed of four domains: physical health, psychological health, social relationships and environment. It also includes one question on overall quality of life and one on general health. Importantly, items on this scale are not dependent on mobility, which is unlikely to change in patients with Spinal Cord Injury/Disease as a result of improved sleep. The WHOQOL-BREF scores correlate highly (.89 or above) with WHOQOL-100 scores, and demonstrate good discriminant validity, content validity, internal consistency and test-retest reliability. The four WHOQOL-BREF domain scores will be used as main outcome measure. The WHOQOL-BREF measures quality of life across 4 domains. The measure is calculated by summing the point values for the questions corresponding to each domain and then transforming the scores to a 0-100 point interval, higher score correspond to greater perceived quality of life
Measured: 90 days
Respiratory Function: Spirometry and Respiratory Muscle Force
Spirometry is a simple bedside test used to evaluate lung function. Key spirometry values include forced vital capacity (FVC) and forced expiratory volume over 1 second (FEV1) and the absolute FEV1/FVC ratio. If the FVC and FEV1 are decreased, the absolute FEV1/FVC ratio distinguishes between obstructive and restrictive impairments. A normal absolute FEV1/FVC ratio suggest that restrictive ventilatory impairment may be present, and a reduced FEV1 and absolute FEV1/FVC ratio indicates an obstructive ventilator pattern. The investigators will use supine FVC and maximal inspiratory pressure (MIP) as the key outcome measures for respiratory function for this study, as these are the most representative of respiratory functioning during sleep.
The normal value for the FEV1/FVC ratio is above 0.75. Values lower than 0.70 are suggestive of airflow limitation with an obstructive pattern whilst in restrictive lung diseases, this ratio is normal or high.
Measured: 90 days
Functional Status Was Measured by CHART Questionnaire.
The CHART is a measure of overall function. The scale is divided into five separate domain scores: Physical, Cognitive, Mobility, Occupation, and Social integration.
Each of the five domains scored from 0-100. higher number indicates better outcome.
Measured: 90 days
Depressive Symptom Severity
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item depression module in the PHQ (a self-administered diagnostic instrument for common mental disorders) which is part of the Primary Care Evaluation of Mental Disorders (PRIME-MD) suite of evaluation tools. The PHQ-9 aligns to the DSM-IV diagnostic criteria for depression and is widely used to screen for depression across VA. The PHQ-9 total score will be used to measure depressive symptom severity as an outcome.
As a severity measure, the PHQ-9 score can range from 0 to 27. Higher the value, worse the outcome.
Measured: 90 days
Fatigue Symptoms
The Flinders Fatigue Scale (FFS) is a 7-item fatigue rating scale used to measure general symptoms of fatigue. The FFS total score will be used as an outcome measure.
Total fatigue scores range from 0 to 31, with higher scores indicating greater fatigue.
Measured: 90 days
Epworth Sleepiness Scale
The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire that quantifies daytime sleepiness, with higher scores indicating increased daytime hypersomnolence The ESS is ranging from 0 to 24. higher scores indicate more sleepiness
Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 201730 Mar 2020

First posted12 Jul 2016 (estimated)
Study start1 May 2017
Primary completion30 Sep 2019
Study completion30 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
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: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 73 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02830074
Sponsor's protocol ID: B2116-R
Other IDs: IRX002116A
Status last verified: Apr 2021
First submitted: 7 Jul 2016
Last updated: 19 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Badr AN, Zeineddine S, Salloum A, Pandya N, Mitchell MN, Sankari A, Munoz ID, Badr MS, Martin JL, Kelly MR. Sleep and daytime function in people with spinal cord injury. J Clin Sleep Med. 2025 Nov 1;21(11):1903-1909. doi: 10.5664/jcsm.11804.
PubMed 40590079
Badr MS, Martin JL, Sankari A, Zeineddine S, Salloum A, Henzel MK, Strohl K, Shamim-Uzzaman A, May AM, Fung CH, Pandya N, Carroll S, Mitchell MN. Intensive support does not improve positive-airway pressure use in spinal cord injury/disease: a randomized clinical trial. Sleep. 2024 May 10;47(5):zsae044. doi: 10.1093/sleep/zsae044.
PubMed 38422375
Kelly MR, Zeineddine S, Mitchell MN, Sankari A, Pandya N, Carroll S, Shamim-Uzzaman QA, Salloum A, Badr MS, Martin JL. Insomnia severity predicts depression, anxiety, and posttraumatic stress disorder in veterans with spinal cord injury or disease: a cross-sectional observational study. J Clin Sleep Med. 2023 Apr 1;19(4):695-701. doi: 10.5664/jcsm.10410.
PubMed 36661092

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Spinal Cord Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Does Treatment of Sleep-Disordered Breathing Improve Functional Outcomes in SCI
ClinicalTrials.gov ID: NCT02830074
Acronym / sponsor ID: B2116-R
Conditions: Spinal Cord Injury, Sleep-disordered Breathing, Spinal Cord Disease, Multiple Sclerosis
Keywords: Sleep Apnea Syndromes, Spinal Cord Injuries, Sleep, Quality of life
Study type: Interventional
Recruitment status: Completed
Enrolment: 73 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 1 May 2017 (actual)
Primary completion: 30 Sep 2019 (actual)
Study completion: 30 Mar 2020 (actual)
First posted: 12 Jul 2016 (estimated)
Results: Posted 22 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
The BEST Program	Experimental	Behavioral: Best practices PAP + patient Education +ongoing Support and Traininga combined sleep and PAP adherence program, called the BEST program (Best practices PAP + patient Education + ongoing Support and Training)
Sleep Education and standard SDB treatment	Active comparator	Behavioral: Sleep EducationThis program includes non-directive sleep education plus standard treatment of SDB.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Adult patients with chronic SCI/D (>3 months post injury)
American Spinal Injury Association (ASIA) classification A-D (i.e., excluding those with no evidence of a neurologic deficit based on ASIA classification).

Key exclusion criteria (11 listed)

Patients receiving mechanical ventilation
already using PAP for SDB at optimal compliance
A clinical contraindication that prevents PAP use.
recent health event that may affect sleep, e.g.:
alcohol or substance abuse (<90 days sobriety)

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
Best practices PAP + patient Education +ongoing Support and TrainingThis is a combined sleep and PAP adherence program, called the "BEST" program (Best practices PAP + Education + ongoing Support/Training	Behavioural	The BEST Program
Sleep EducationThis program includes non-directive sleep education plus standard treatment of SDB.	Behavioural	Sleep Education and standard SDB treatment

Primary outcome

PAP Adherence
Time frame: 90 days
Number of nights positive airway pressure (PAP) was used >=4 hours during the first 90 days measured by remote monitoring. Scores range from 0 to 90 days. Higher scores indicate better outcome.
Subjective Sleep Quality Was Measured by The Pittsburgh Sleep Quality Index (PSQI)
Time frame: 90 days
The Pittsburgh Sleep Quality Index (PSQI) is an 18-item questionnaire that assesses sleep quality and disturbances over the past month. The PSQI is sensitive for distinguishing normal and abnormal sleepers and has good test-retest reliability. The investigators will use the 3-factor scoring, which has been shown to have superior psychometric properties. This will be used as the main independent measure of sleep quality. The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality

6 secondary outcomes

Quality of Life Was Measured by WHO-QOL BREF Questionnaire
Time frame: 90 days
Respiratory Function: Spirometry and Respiratory Muscle Force
Time frame: 90 days
Functional Status Was Measured by CHART Questionnaire.
Time frame: 90 days
Depressive Symptom Severity
Time frame: 90 days
Fatigue Symptoms
Time frame: 90 days
Epworth Sleepiness Scale
Time frame: 90 days

Results and safety

Results posted to the registry on 22 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
The BEST Program	32	32
Sleep Education and Standard SDB Treatment	31	31

Primary outcome: PAP Adherence

Time frame: 90 days. Mean (Standard Deviation). Unit: nights

Measure	The BEST Program n = 32	Sleep Education and Standard Sleep-disordered Breathing Treatment n = 31
Value	22.03 (24.74)	18.54 (24.67)

Primary outcome: Subjective Sleep Quality Was Measured by The Pittsburgh Sleep Quality Index (PSQI)

Time frame: 90 days. Mean (Standard Deviation). Unit: units on a scale

Measure	The BEST Program n = 30	Sleep Education and Standard Sleep-disordered Breathing Treatment n = 30
Value	6.96 (4.12)	9.1 (4.97)

Population analysed: 63 were randomized, 60 participants were analyzed for the 90 day period, due to missing data on study forms

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 90 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
The BEST Program	0 of 32 (0%)	0 of 32 (0%)	0 of 32
Sleep Education and Standard SDB Treatment	0 of 31 (0%)	0 of 31 (0%)	0 of 31

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40590079Badr AN, Zeineddine S, Salloum A, Pandya N, Mitchell MN, Sankari A, Munoz ID, Badr MS, Martin JL, Kelly MR. Sleep and daytime function in people with spinal cord injury. J Clin Sleep Med. 2025 Nov 1;21(11):1903-1909. doi: 10.5664/jcsm.11804.
Derived from this study: PubMed 38422375Badr MS, Martin JL, Sankari A, Zeineddine S, Salloum A, Henzel MK, Strohl K, Shamim-Uzzaman A, May AM, Fung CH, Pandya N, Carroll S, Mitchell MN. Intensive support does not improve positive-airway pressure use in spinal cord injury/disease: a randomized clinical trial. Sleep. 2024 May 10;47(5):zsae044. doi: 10.1093/sleep/zsae044.
Derived from this study: PubMed 36661092Kelly MR, Zeineddine S, Mitchell MN, Sankari A, Pandya N, Carroll S, Shamim-Uzzaman QA, Salloum A, Badr MS, Martin JL. Insomnia severity predicts depression, anxiety, and posttraumatic stress disorder in veterans with spinal cord injury or disease: a cross-sectional observational study. J Clin Sleep Med. 2023 Apr 1;19(4):695-701. doi: 10.5664/jcsm.10410.
Individual participant dataSharing planned: No

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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.

M S Badr, MD principal investigator

John D. Dingell VA Medical Center, Detroit, MI

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 11 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 19 May 2021. 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 United States. 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. 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?

Yes. Results are posted in the registry (first posted 22 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

PAP Adherence (time frame: 90 days). The study lists 2 primary outcomes in all. 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 NCT02830074, which also lists 3 linked publications.

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 19 May 2021.