N/A
N=63
Treatment of Sleep-disordered Breathing in Patients With SCI
Spinal Cord Injury · Sleep-disordered Breathing · Spinal Cord Disease · Multiple Sclerosis
Bottom Line
View on ClinicalTrials.gov: NCT02830074 ↗Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: PAP Adherence — 22.03; 18.54 nights
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Best practices PAP + patient Education +ongoing Support and Training (Behavioral); Sleep Education (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PAP Adherence |
22.03; 18.54 | — |
| PRIMARY Subjective Sleep Quality Was Measured by The Pittsburgh Sleep Quality Index (PSQI) |
6.96; 9.1 | — |
| SECONDARY Quality of Life Was Measured by WHO-QOL BREF Questionnaire |
60.13; 54.72; 69.22; 62.90; 63.70; 57.52 | — |
| SECONDARY Respiratory Function: Spirometry and Respiratory Muscle Force |
3.38; 3.20 | — |
| SECONDARY Functional Status Was Measured by CHART Questionnaire. |
79.09; 82.70; 70.70; 78.83; 82.20; 78.17 | — |
| SECONDARY Depressive Symptom Severity |
5.03; 8.38 | — |
| SECONDARY Fatigue Symptoms |
9.61; 12.12 | — |
| SECONDARY Epworth Sleepiness Scale |
4.58; 6.48 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02830074). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.