Treatment of Sleep-disordered Breathing in Patients With SCI
Does Treatment of Sleep-Disordered Breathing Improve Functional Outcomes in SCI
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Best practices PAP + patient Education +ongoing Support and Training
Compared with
- Sleep Education
Results by group
PAP Adherence
90 days
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| The BEST Program | 22.03 nights | 24.74 (Standard Deviation) | 32 |
| Sleep Education and Standard Sleep-disordered Breathing Treatment | 18.54 nights | 24.67 (Standard Deviation) | 31 |
The BEST Program
Sleep Education and Standard Sleep-disordered Breathing Treatment
Subjective Sleep Quality Was Measured by The Pittsburgh Sleep Quality Index (PSQI)
90 days
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| The BEST Program | 6.96 units on a scale | 4.12 (Standard Deviation) | 30 |
| Sleep Education and Standard Sleep-disordered Breathing Treatment | 9.1 units on a scale | 4.97 (Standard Deviation) | 30 |
The BEST Program
Sleep Education and Standard Sleep-disordered Breathing Treatment
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| The BEST Program | 32 | 0 (0.0%) | 0 |
| Sleep Education and Standard SDB Treatment | 31 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
PAP Adherence
90 days
Quality of life (reported by participants)Subjective Sleep Quality Was Measured by The Pittsburgh Sleep Quality Index (PSQI)
90 days
Mood and sleep
Other measures (6)
Quality of Life Was Measured by WHO-QOL BREF Questionnaire
90 days
Walking and mobilityMood and sleepQuality of life (reported by participants)Respiratory Function: Spirometry and Respiratory Muscle Force
90 days
Physical functionMood and sleepFunctional Status Was Measured by CHART Questionnaire.
90 days
Thinking and memoryWalking and mobilityDepressive Symptom Severity
90 days
Mood and sleepFatigue Symptoms
90 days
FatigueEpworth Sleepiness Scale
90 days
Mood and sleep
Who could take part
MS (type not specified) · 18 and over
Show the full criteria
Inclusion criteria
* 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).
Exclusion criteria
* 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
Sleep and daytime function in people with spinal cord injury.J Clin Sleep Med · 2025
Results
Intensive support does not improve positive-airway pressure use in spinal cord injury/disease: a randomized clinical trial.Sleep · 2024
Results
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.
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History
Started
May 2017
Main results due
Sept 2019
Finished
Mar 2020
Results posted
Apr 2021