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Treatment of Sleep-disordered Breathing in Patients With SCI
NA trial testing Best practices PAP + patient Education +ongoing Support and Training in Spinal Cord Injury in 73 participants. Completed in 30 March 2020.
| Lead sponsor | VA Office of Research and Development |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 73 |
| Start date | 1 May 2017 |
| Primary completion | 30 September 2019 |
| Estimated completion | 30 March 2020 |
| Sites | 1 location across United States |
VA Office of Research and Development — full company profile →
18 and older, any sex, with Spinal Cord Injury or Sleep-disordered Breathing. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| The BEST Program | 22.03 | ± 24.74 |
| Sleep Education and Standard Sleep-disordered Breathing Treatment | 18.54 | ± 24.67 |
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
| Group | Value | 95% CI |
|---|---|---|
| The BEST Program | 6.96 | ± 4.12 |
| Sleep Education and Standard Sleep-disordered Breathing Treatment | 9.1 | ± 4.97 |
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
| Group | Value | 95% CI |
|---|---|---|
| The BEST Program | 60.13 | ± 21.37 |
| Sleep Education and Standard Sleep-disordered Breathing (SDB) Treatment | 54.72 | ± 22.08 |
| Group | Value | 95% CI |
|---|---|---|
| The BEST Program | 69.22 | ± 14.69 |
| Sleep Education and Standard Sleep-disordered Breathing (SDB) Treatment | 62.90 | ± 19.64 |
| Group | Value | 95% CI |
|---|---|---|
| The BEST Program | 63.70 | ± 24.39 |
| Sleep Education and Standard Sleep-disordered Breathing (SDB) Treatment | 57.52 | ± 23.20 |
| Group | Value | 95% CI |
|---|---|---|
| The BEST Program | 74.09 | ± 12.66 |
| Sleep Education and Standard Sleep-disordered Breathing (SDB) Treatment | 69.75 | ± 18.40 |
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)
| Group | Value | 95% CI |
|---|---|---|
| The BEST Program | 3.38 | ± 1.04 |
| Sleep Education and Standard Sleep-disordered Breathing (SDB) Treatment | 3.20 | ± 0.97 |
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.
| Group | Value | 95% CI |
|---|---|---|
| The BEST Program | 79.09 | ± 31.02 |
| Sleep Education and Standard Sleep-disordered Breathing (SDB) Treatment | 82.70 | ± 31.39 |
| Group | Value | 95% CI |
|---|---|---|
| The BEST Program | 70.70 | ± 23.90 |
| Sleep Education and Standard Sleep-disordered Breathing (SDB) Treatment | 78.83 | ± 22.44 |
| Group | Value | 95% CI |
|---|---|---|
| The BEST Program | 82.20 | ± 19.64 |
| Sleep Education and Standard Sleep-disordered Breathing (SDB) Treatment | 78.17 | ± 24.33 |
| Group | Value | 95% CI |
|---|---|---|
| The BEST Program | 48.98 | ± 31.39 |
| Sleep Education and Standard Sleep-disordered Breathing (SDB) Treatment | 38.90 | ± 33.76 |
| Group | Value | 95% CI |
|---|---|---|
| The BEST Program | 79 | ± 23.64 |
| Sleep Education and Standard Sleep-disordered Breathing (SDB) Treatment | 66.80 | ± 29.42 |
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.
| Group | Value | 95% CI |
|---|---|---|
| The BEST Program | 5.03 | ± 5.89 |
| Sleep Education and Standard Sleep-disordered Breathing (SDB) Treatment | 8.38 | ± 6.44 |
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.
| Group | Value | 95% CI |
|---|---|---|
| The BEST Program | 9.61 | ± 8.46 |
| Sleep Education and Standard Sleep-disordered Breathing (SDB) Treatment | 12.12 | ± 9.33 |
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
| Group | Value | 95% CI |
|---|---|---|
| The BEST Program | 4.58 | ± 4.94 |
| Sleep Education and Standard Sleep-disordered Breathing (SDB) Treatment | 6.48 | ± 4.13 |
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.
5 peer-reviewed publications reference this trial (live from Europe PMC):
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