Trial Outcomes & Findings for Treatment of Sleep-disordered Breathing in Patients With SCI (NCT NCT02830074)
NCT ID: NCT02830074
Last Updated: 2021-05-19
Results Overview
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.
COMPLETED
NA
73 participants
90 days
2021-05-19
Participant Flow
73 Participants started the study and out of those 73 participants only 63 were randomized. Therefore, only 63 participants out of 73 were eligible to be randomized ( 1 ineligible, 3 withdraw, 3 passive withdraw, 2 AHI\<5, 1 Pilot).
Participant milestones
| Measure |
The BEST Program
a combined sleep and PAP adherence program, called the BEST program (Best practices PAP + patient Education + ongoing Support and Training)
Best practices PAP + patient Education +ongoing Support and Training: This is a combined sleep and PAP adherence program, called the "BEST" program (Best practices PAP + Education + ongoing Support/Training
|
Sleep Education and Standard SDB Treatment
This program includes non-directive sleep education plus standard treatment of SDB.
Sleep Education: This program includes non-directive sleep education plus standard treatment of SDB.
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
31
|
|
Overall Study
COMPLETED
|
32
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment of Sleep-disordered Breathing in Patients With SCI
Baseline characteristics by cohort
| Measure |
The BEST Program
n=32 Participants
a combined sleep and PAP adherence program, called the ?BEST? program (Best practices PAP + patient Education + ongoing Support and Training)
Best practices PAP + patient Education +ongoing Support and Training: This is a combined sleep and PAP adherence program, called the "BEST" program (Best practices PAP + Education + ongoing Support/Training
|
Sleep Education and Standard SDB Treatment
n=31 Participants
This program includes non-directive sleep education plus standard treatment of SDB.
Sleep Education: This program includes non-directive sleep education plus standard treatment of SDB.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.63 years
STANDARD_DEVIATION 10.02 • n=5 Participants
|
59.80 years
STANDARD_DEVIATION 10.44 • n=7 Participants
|
60.73 years
STANDARD_DEVIATION 10.18 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
32 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Apnea Hypopnea Index (AHI)
|
30.19 events/hr
STANDARD_DEVIATION 22.92 • n=5 Participants
|
30.32 events/hr
STANDARD_DEVIATION 24.87 • n=7 Participants
|
30.25 events/hr
STANDARD_DEVIATION 23.71 • n=5 Participants
|
PRIMARY outcome
Timeframe: 90 daysNumber 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.
Outcome measures
| Measure |
The BEST Program
n=32 Participants
a combined sleep and PAP adherence program, called the BEST program (Best practices PAP + patient Education + ongoing Support and Training)
Best practices PAP + patient Education +ongoing Support and Training: This is a combined sleep and PAP adherence program, called the "BEST" program (Best practices PAP + Education + ongoing Support/Training
|
Sleep Education and Standard Sleep-disordered Breathing Treatment
n=31 Participants
This program includes non-directive sleep education plus standard treatment of sleep-disordered breathing .
Sleep Education: This program includes non-directive sleep education plus standard treatment of sleep-disordered breathing .
|
|---|---|---|
|
PAP Adherence
|
22.03 nights
Standard Deviation 24.74
|
18.54 nights
Standard Deviation 24.67
|
PRIMARY outcome
Timeframe: 90 daysPopulation: 63 were randomized, 60 participants were analyzed for the 90 day period, due to missing data on study forms
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
Outcome measures
| Measure |
The BEST Program
n=30 Participants
a combined sleep and PAP adherence program, called the BEST program (Best practices PAP + patient Education + ongoing Support and Training)
Best practices PAP + patient Education +ongoing Support and Training: This is a combined sleep and PAP adherence program, called the "BEST" program (Best practices PAP + Education + ongoing Support/Training
|
Sleep Education and Standard Sleep-disordered Breathing Treatment
n=30 Participants
This program includes non-directive sleep education plus standard treatment of sleep-disordered breathing .
Sleep Education: This program includes non-directive sleep education plus standard treatment of sleep-disordered breathing .
|
|---|---|---|
|
Subjective Sleep Quality Was Measured by The Pittsburgh Sleep Quality Index (PSQI)
|
6.96 units on a scale
Standard Deviation 4.12
|
9.1 units on a scale
Standard Deviation 4.97
|
SECONDARY outcome
Timeframe: 90 daysPopulation: 63 were randomized, 62 participants were analyzed for the 90 day period, due to missing data on study forms.
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
Outcome measures
| Measure |
The BEST Program
n=31 Participants
a combined sleep and PAP adherence program, called the BEST program (Best practices PAP + patient Education + ongoing Support and Training)
Best practices PAP + patient Education +ongoing Support and Training: This is a combined sleep and PAP adherence program, called the "BEST" program (Best practices PAP + Education + ongoing Support/Training
|
Sleep Education and Standard Sleep-disordered Breathing Treatment
n=31 Participants
This program includes non-directive sleep education plus standard treatment of sleep-disordered breathing .
Sleep Education: This program includes non-directive sleep education plus standard treatment of sleep-disordered breathing .
|
|---|---|---|
|
Quality of Life Was Measured by WHO-QOL BREF Questionnaire
WHO-QOL phys
|
60.13 units on a scale
Standard Deviation 21.37
|
54.72 units on a scale
Standard Deviation 22.08
|
|
Quality of Life Was Measured by WHO-QOL BREF Questionnaire
WHO-QOL psych
|
69.22 units on a scale
Standard Deviation 14.69
|
62.90 units on a scale
Standard Deviation 19.64
|
|
Quality of Life Was Measured by WHO-QOL BREF Questionnaire
WHO-QOL Soc
|
63.70 units on a scale
Standard Deviation 24.39
|
57.52 units on a scale
Standard Deviation 23.20
|
|
Quality of Life Was Measured by WHO-QOL BREF Questionnaire
WHO-QOL ENV
|
74.09 units on a scale
Standard Deviation 12.66
|
69.75 units on a scale
Standard Deviation 18.40
|
SECONDARY outcome
Timeframe: 90 daysPopulation: 63 were randomized, 60 participants were analyzed for the 90 day period, due to missing data on study forms.
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.
Outcome measures
| Measure |
The BEST Program
n=30 Participants
a combined sleep and PAP adherence program, called the BEST program (Best practices PAP + patient Education + ongoing Support and Training)
Best practices PAP + patient Education +ongoing Support and Training: This is a combined sleep and PAP adherence program, called the "BEST" program (Best practices PAP + Education + ongoing Support/Training
|
Sleep Education and Standard Sleep-disordered Breathing Treatment
n=30 Participants
This program includes non-directive sleep education plus standard treatment of sleep-disordered breathing .
Sleep Education: This program includes non-directive sleep education plus standard treatment of sleep-disordered breathing .
|
|---|---|---|
|
Respiratory Function: Spirometry and Respiratory Muscle Force
|
3.38 ratio
Standard Deviation 1.04
|
3.20 ratio
Standard Deviation 0.97
|
SECONDARY outcome
Timeframe: 90 daysPopulation: 63 were randomized, 62 participants were analyzed for the 90 day period, due to missing data on study forms
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.
Outcome measures
| Measure |
The BEST Program
n=31 Participants
a combined sleep and PAP adherence program, called the BEST program (Best practices PAP + patient Education + ongoing Support and Training)
Best practices PAP + patient Education +ongoing Support and Training: This is a combined sleep and PAP adherence program, called the "BEST" program (Best practices PAP + Education + ongoing Support/Training
|
Sleep Education and Standard Sleep-disordered Breathing Treatment
n=31 Participants
This program includes non-directive sleep education plus standard treatment of sleep-disordered breathing .
Sleep Education: This program includes non-directive sleep education plus standard treatment of sleep-disordered breathing .
|
|---|---|---|
|
Functional Status Was Measured by CHART Questionnaire.
Physical
|
79.09 units on a scale
Standard Deviation 31.02
|
82.70 units on a scale
Standard Deviation 31.39
|
|
Functional Status Was Measured by CHART Questionnaire.
Cognitive
|
70.70 units on a scale
Standard Deviation 23.90
|
78.83 units on a scale
Standard Deviation 22.44
|
|
Functional Status Was Measured by CHART Questionnaire.
Mobility
|
82.20 units on a scale
Standard Deviation 19.64
|
78.17 units on a scale
Standard Deviation 24.33
|
|
Functional Status Was Measured by CHART Questionnaire.
Occupation
|
48.98 units on a scale
Standard Deviation 31.39
|
38.90 units on a scale
Standard Deviation 33.76
|
|
Functional Status Was Measured by CHART Questionnaire.
Social integration
|
79 units on a scale
Standard Deviation 23.64
|
66.80 units on a scale
Standard Deviation 29.42
|
SECONDARY outcome
Timeframe: 90 daysPopulation: 63 were randomized, 62 participants were analyzed for the 90 day period, due to missing data on study forms
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.
Outcome measures
| Measure |
The BEST Program
n=31 Participants
a combined sleep and PAP adherence program, called the BEST program (Best practices PAP + patient Education + ongoing Support and Training)
Best practices PAP + patient Education +ongoing Support and Training: This is a combined sleep and PAP adherence program, called the "BEST" program (Best practices PAP + Education + ongoing Support/Training
|
Sleep Education and Standard Sleep-disordered Breathing Treatment
n=31 Participants
This program includes non-directive sleep education plus standard treatment of sleep-disordered breathing .
Sleep Education: This program includes non-directive sleep education plus standard treatment of sleep-disordered breathing .
|
|---|---|---|
|
Depressive Symptom Severity
|
5.03 units on a scale
Standard Deviation 5.89
|
8.38 units on a scale
Standard Deviation 6.44
|
SECONDARY outcome
Timeframe: 90 daysPopulation: 63 were randomized, 62 participants were analyzed for the 90 day period, due to missing data on study forms
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.
Outcome measures
| Measure |
The BEST Program
n=31 Participants
a combined sleep and PAP adherence program, called the BEST program (Best practices PAP + patient Education + ongoing Support and Training)
Best practices PAP + patient Education +ongoing Support and Training: This is a combined sleep and PAP adherence program, called the "BEST" program (Best practices PAP + Education + ongoing Support/Training
|
Sleep Education and Standard Sleep-disordered Breathing Treatment
n=31 Participants
This program includes non-directive sleep education plus standard treatment of sleep-disordered breathing .
Sleep Education: This program includes non-directive sleep education plus standard treatment of sleep-disordered breathing .
|
|---|---|---|
|
Fatigue Symptoms
|
9.61 units on a scale
Standard Deviation 8.46
|
12.12 units on a scale
Standard Deviation 9.33
|
SECONDARY outcome
Timeframe: 90 daysPopulation: 63 were randomized, 62 participants were analyzed for the 90 day period, due to missing data on study forms
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
Outcome measures
| Measure |
The BEST Program
n=31 Participants
a combined sleep and PAP adherence program, called the BEST program (Best practices PAP + patient Education + ongoing Support and Training)
Best practices PAP + patient Education +ongoing Support and Training: This is a combined sleep and PAP adherence program, called the "BEST" program (Best practices PAP + Education + ongoing Support/Training
|
Sleep Education and Standard Sleep-disordered Breathing Treatment
n=31 Participants
This program includes non-directive sleep education plus standard treatment of sleep-disordered breathing .
Sleep Education: This program includes non-directive sleep education plus standard treatment of sleep-disordered breathing .
|
|---|---|---|
|
Epworth Sleepiness Scale
|
4.58 units on a scale
Standard Deviation 4.94
|
6.48 units on a scale
Standard Deviation 4.13
|
Adverse Events
The BEST Program
Sleep Education and Standard SDB Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. M.Safwan Badr, MD, Ph.D.
John D. Dingell VA Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place