NCT02830074

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 12, 2016

Completed
10 months until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 22, 2021

Completed
Last Updated

May 19, 2021

Status Verified

April 1, 2021

Enrollment Period

2.4 years

First QC Date

July 7, 2016

Results QC Date

February 4, 2021

Last Update Submit

April 26, 2021

Conditions

Spinal Cord InjurySleep-disordered BreathingSpinal Cord DiseaseMultiple Sclerosis

Keywords

Sleep Apnea SyndromesSpinal Cord InjuriesSleepQuality of life

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    90 days

Secondary Outcomes (6)

  • Quality of Life Was Measured by WHO-QOL BREF Questionnaire

    90 days

  • Respiratory Function: Spirometry and Respiratory Muscle Force

    90 days

  • Functional Status Was Measured by CHART Questionnaire.

    90 days

  • Depressive Symptom Severity

    90 days

  • Fatigue Symptoms

    90 days

  • +1 more secondary outcomes

Study Arms (2)

The BEST Program

EXPERIMENTAL

a combined sleep and PAP adherence program, called the BEST program (Best practices PAP + patient Education + ongoing Support and Training)

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.

Behavioral: Sleep Education

Interventions

Best practices PAP + patient Education +ongoing Support and TrainingBEHAVIORAL

This is a combined sleep and PAP adherence program, called the "BEST" program (Best practices PAP + Education + ongoing Support/Training

The BEST Program
Sleep EducationBEHAVIORAL

This program includes non-directive sleep education plus standard treatment of SDB.

Sleep Education and standard SDB treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

John D. Dingell VA Medical Center, Detroit, MI

Detroit, Michigan, 48201, United States

Location

Related Publications (3)

  • 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.

    PMID: 40590079DERIVED

  • 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.

    PMID: 38422375DERIVED

  • 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.

    PMID: 36661092DERIVED

MeSH Terms

Conditions

Spinal Cord InjuriesSleep Apnea SyndromesSpinal Cord DiseasesMultiple Sclerosis

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Dr. M.Safwan Badr, MD, Ph.D.
Organization
John D. Dingell VA Medical Center
m.badr@va.gov
3135763548

Study Officials

  • M S Badr, MD

    John D. Dingell VA Medical Center, Detroit, MI

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2016

First Posted

July 12, 2016

Study Start

May 1, 2017

Primary Completion

September 30, 2019

Study Completion

March 30, 2020

Last Updated

May 19, 2021

Results First Posted

April 22, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)