Trial Outcomes & Findings for Comparison of Sleep Apnea Assessment Strategies to Maximize TBI Rehabilitation Participation and Outcome (NCT NCT03033901)
NCT ID: NCT03033901
Last Updated: 2023-03-29
Results Overview
A diagnosis of sleep apnea will be determined by overall apnea-hypopnea index (AHI) greater or equal to 5 and greater than or equal to 15 denoting different severity levels of disease.
COMPLETED
345 participants
During inpatient brain injury rehabilitation, which can occur on average (median) up to 37 days post-traumatic brain injury (TBI) in civilian settings and 132 days in Veterans Affairs (VA) settings.
2023-03-29
Participant Flow
Participant milestones
| Measure |
Single Group
Potential participants were screened for eligibility. Upon meeting study eligibility requirements, they were asked to consent. Upon consenting, they were screened additional study requirements before undergoing polysomnography.
|
|---|---|
|
Overall Study
STARTED
|
345
|
|
Overall Study
COMPLETED
|
248
|
|
Overall Study
NOT COMPLETED
|
97
|
Reasons for withdrawal
| Measure |
Single Group
Potential participants were screened for eligibility. Upon meeting study eligibility requirements, they were asked to consent. Upon consenting, they were screened additional study requirements before undergoing polysomnography.
|
|---|---|
|
Overall Study
Ineligible for Polysomnography (PSG)
|
59
|
|
Overall Study
Refused PSG
|
23
|
|
Overall Study
Total Sleep Time < 2 hours
|
12
|
|
Overall Study
Missing Oximetry Data
|
3
|
Baseline Characteristics
Comparison of Sleep Apnea Assessment Strategies to Maximize TBI Rehabilitation Participation and Outcome
Baseline characteristics by cohort
| Measure |
Single Group
n=248 Participants
Potential participants were screened for eligibility. Upon meeting study eligibility requirements, they were asked to consent. Upon consenting, they were screened additional study requirements before undergoing polysomnography.
|
|---|---|
|
Age, Continuous
|
43.6 years
STANDARD_DEVIATION 17.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
203 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
33 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
184 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
49 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
248 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During inpatient brain injury rehabilitation, which can occur on average (median) up to 37 days post-traumatic brain injury (TBI) in civilian settings and 132 days in Veterans Affairs (VA) settings.A diagnosis of sleep apnea will be determined by overall apnea-hypopnea index (AHI) greater or equal to 5 and greater than or equal to 15 denoting different severity levels of disease.
Outcome measures
| Measure |
Single Group
n=248 Participants
Potential participants were screened for eligibility. Upon meeting study eligibility requirements, they were asked to consent. Upon consenting, they were screened additional study requirements before undergoing polysomnography.
|
|---|---|
|
Apnea-Hypopnea Index (AHI)
|
24.4 times per hour
Standard Deviation 5.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During inpatient brain injury rehabilitation, which can occur on average (median) up to 37 days post-TBI in civilian settings and 132 days in VA settings.Sleep apnea screening measure. Risk based on responses to 8 items (2,low risk; 3-4, intermediate risk; \>5, high risk).
Outcome measures
| Measure |
Single Group
n=248 Participants
Potential participants were screened for eligibility. Upon meeting study eligibility requirements, they were asked to consent. Upon consenting, they were screened additional study requirements before undergoing polysomnography.
|
|---|---|
|
STOPBang Sleep Apnea Risk
|
2.56 units on a scale
Standard Deviation 1.30
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During inpatient brain injury rehabilitation, which can occur on average (median) up to 37 days post-TBI in civilian settings and 132 days in VA settings.Sleep apnea screening measure with 10-items. Risk stratification is based on number of items: no risk (no items endorsed), low (endorsement of 1 item) or high risk (endorsement of 2 or more items).
Outcome measures
| Measure |
Single Group
n=248 Participants
Potential participants were screened for eligibility. Upon meeting study eligibility requirements, they were asked to consent. Upon consenting, they were screened additional study requirements before undergoing polysomnography.
|
|---|---|
|
Berlin Sleep Apnea Risk
High risk: 2 categories positive
|
54 participants
|
|
Berlin Sleep Apnea Risk
Low risk: 1 category positive
|
119 participants
|
|
Berlin Sleep Apnea Risk
Missing
|
75 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During inpatient brain injury rehabilitation, which can occur on average (median) up to 37 days post-TBI in civilian settings and 132 days in VA settings.Population: N with complete data = 245. N missing = 3.
Philips brand Actiwatch Spectrum used to measure total sleep time
Outcome measures
| Measure |
Single Group
n=245 Participants
Potential participants were screened for eligibility. Upon meeting study eligibility requirements, they were asked to consent. Upon consenting, they were screened additional study requirements before undergoing polysomnography.
|
|---|---|
|
Actigraphy
|
404.7 minutes
Standard Deviation 74.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During inpatient brain injury rehabilitation, which can occur on average (median) up to 37 days post-TBI in civilian settings and 132 days in VA settings.The questionnaire consists of 3 breathing-related questions and information on demographics (sex, weight, height, age), from which a probability of having sleep apnea (0%-100%) can be calculated. The test-retest reliability of the breathing questions is 0.92 and has a good internal consistency with Cronbach a of 0.85-0.93. A MAPI score of 0.50 (ie, calculated 0% likelihood of having clinically significant sleep apnea with a Respiratory Distress Index\>10) has a 0.88 sensitivity and 0.55 specificity.
Outcome measures
| Measure |
Single Group
n=248 Participants
Potential participants were screened for eligibility. Upon meeting study eligibility requirements, they were asked to consent. Upon consenting, they were screened additional study requirements before undergoing polysomnography.
|
|---|---|
|
Multivariate Apnea Prediction Index (MAPI)
|
0.23 percent probability
Standard Deviation 0.20
|
Adverse Events
Single Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place