Trial Outcomes & Findings for Feasibility of Improving Sleep Apnea Treatment Adherence After Brain Injury (NCT NCT04221009)

Last Updated: 2024-07-08

Results Overview

The Narrative Evaluation of Intervention Interview is a 16-item semi-structured interview that elicits participant feedback about an intervention. The data yielded by the NEII are qualitative, using qualitative thematic analysis. All 13 participants who completed the study also completed the NEII interview.

Recruitment status

COMPLETED

Study phase

Target enrollment

17 participants

Primary outcome timeframe

Post-intervention (up to 8 weeks after completion of the single arm intervention)

Results posted on

2024-07-08

Participant Flow

Participants were recruited from inpatient TBI units and outpatient TBI clinics per IRB-approved protocol. The recruitment period occurred between August 2020 and December 2021.

All 17 participants who agreed to participate were enrolled in the study and assigned to the single arm of the study.

Participant milestones

Participant milestones
Measure	Intervention (Single Arm) This is a 4-session intervention derived from Motivational Interviewing and Cognitive Behavior Therapy and adapted with cognitive accommodations. MI and CBT 4-session manualized intervention: This is a 4-session intervention derived from Motivational Interviewing and Cognitive Behavior Therapy and adapted with cognitive accommodations.
Overall Study STARTED	17
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Intervention (Single Arm) This is a 4-session intervention derived from Motivational Interviewing and Cognitive Behavior Therapy and adapted with cognitive accommodations. MI and CBT 4-session manualized intervention: This is a 4-session intervention derived from Motivational Interviewing and Cognitive Behavior Therapy and adapted with cognitive accommodations.
Overall Study Withdrawal by Subject	4

Baseline Characteristics

1 participant did not complete the FSS

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention (Single Arm) n=17 Participants This is a 4-session intervention derived from Motivational Interviewing and Cognitive Behavior Therapy and adapted with cognitive accommodations. MI and CBT 4-session manualized intervention: This is a 4-session intervention derived from Motivational Interviewing and Cognitive Behavior Therapy and adapted with cognitive accommodations.
Age, Continuous	53.2 Years STANDARD_DEVIATION 11.8 • n=17 Participants
Sex: Female, Male Female	0 Participants n=17 Participants
Sex: Female, Male Male	17 Participants n=17 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=17 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=17 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=17 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=17 Participants
Race (NIH/OMB) Asian	0 Participants n=17 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=17 Participants
Race (NIH/OMB) Black or African American	1 Participants n=17 Participants
Race (NIH/OMB) White	14 Participants n=17 Participants
Race (NIH/OMB) More than one race	0 Participants n=17 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=17 Participants
Region of Enrollment United States	17 Participants n=17 Participants
Apnea-Hypopnea Index (AHI)	22.9 Events per hour STANDARD_DEVIATION 28.2 • n=17 Participants
Oxygenation Nadir	86.0 % peripheral oxygen saturation STANDARD_DEVIATION 3.8 • n=17 Participants
Glasgow Outcome Scale-Extended (GOS-E)	5.2 units on a scale STANDARD_DEVIATION 1.4 • n=17 Participants
Fatigue Severity Scale (FSS)	41.7 units on a scale STANDARD_DEVIATION 15.2 • n=16 Participants • 1 participant did not complete the FSS
Functional Outcome of Sleep Questionnaire (FOSQ)	14.0 units on a scale STANDARD_DEVIATION 4.1 • n=15 Participants • 2 participants did not complete the FOSQ
OSA Treatment Barriers Questionnaire (OTBQ)	13.3 units on a scale STANDARD_DEVIATION 4.1 • n=15 Participants • 2 participants did not complete the OTBQ
Self Efficacy Measure for Sleep Apnea (SEMSA) Risk Perception	15.9 units on a scale STANDARD_DEVIATION 4.7 • n=15 Participants • 2 participants did not complete the SEMSA Risk Perception
Self Efficacy Measure for Sleep Apnea (SEMSA) Outcome Expectancies	28.2 units on a scale STANDARD_DEVIATION 4.2 • n=15 Participants • 2 participants did not complete the SEMSA Outcome Expectancies
Self Efficacy Measure for Sleep Apnea (SEMSA) Treatment Self-efficacy	23.7 units on a scale STANDARD_DEVIATION 7.1 • n=15 Participants • 2 participants did not complete the SEMSA Treatment Self-Efficacy
Epworth Sleepiness Scale (ESS)	11.9 units on a scale STANDARD_DEVIATION 4.8 • n=15 Participants • 2 participants did not complete the ESS

PRIMARY outcome

Timeframe: Post-intervention (up to 8 weeks after completion of the single arm intervention)

Outcome measures

Outcome measures
Measure	Intervention (Single Arm) n=13 Participants This is a 4-session intervention derived from Motivational Interviewing and Cognitive Behavior Therapy and adapted with cognitive accommodations. MI and CBT 4-session manualized intervention: This is a 4-session intervention derived from Motivational Interviewing and Cognitive Behavior Therapy and adapted with cognitive accommodations.
Narrative Evaluation of Intervention Interview (Post-intervention Qualitative Interview)	4 Themes

SECONDARY outcome

Timeframe: Single time point, following completion of the single arm intervention, up to 12 weeks post-intervention

The Epworth Sleepiness Scale is an 8-item validated measure of daytime sleepiness. Respondents rate how likely they are to doze in eight situations, each on a scale from 0 to 3. Scores range from 0 to 24. Higher scores representing greater levels of excessive sleepiness

Outcome measures

Outcome measures
Measure	Intervention (Single Arm) n=13 Participants This is a 4-session intervention derived from Motivational Interviewing and Cognitive Behavior Therapy and adapted with cognitive accommodations. MI and CBT 4-session manualized intervention: This is a 4-session intervention derived from Motivational Interviewing and Cognitive Behavior Therapy and adapted with cognitive accommodations.
Epworth Sleepiness Scale	11.0 units on a scale Standard Deviation 5.0

SECONDARY outcome

Timeframe: Single time point, following completion of the single arm intervention, up to 12 weeks post-intervention

The Fatigue Severity Scale is a 9-item measure that is sensitive to change following OSA treatment. Respondents rate (on a scale from 1 to 7) the degree of fatigue symptoms experienced within the past 7 days. Total scores range from 9 to 63. Higher scores denote worse fatigue.

Outcome measures

Outcome measures
Measure	Intervention (Single Arm) n=13 Participants This is a 4-session intervention derived from Motivational Interviewing and Cognitive Behavior Therapy and adapted with cognitive accommodations. MI and CBT 4-session manualized intervention: This is a 4-session intervention derived from Motivational Interviewing and Cognitive Behavior Therapy and adapted with cognitive accommodations.
Fatigue Severity Scale	36.4 units on a scale Standard Deviation 15.6

SECONDARY outcome

Timeframe: Single time point, following completion of the single arm intervention, up to 12 weeks post-intervention

The Functional Outcomes of Sleep Questionnaire is a 30-item instrument that measures the impact of excessive sleepiness on quality of life in five domains. Items are rated from 1 to 4. Scores range from 1 to 120. Lower scores denote greater impact on quality of life.

Outcome measures

Outcome measures
Measure	Intervention (Single Arm) n=13 Participants This is a 4-session intervention derived from Motivational Interviewing and Cognitive Behavior Therapy and adapted with cognitive accommodations. MI and CBT 4-session manualized intervention: This is a 4-session intervention derived from Motivational Interviewing and Cognitive Behavior Therapy and adapted with cognitive accommodations.
Functional Outcomes of Sleep Questionnaire	14.7 units on a scale Standard Deviation 3.7

Adverse Events

Intervention (Single Arm)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Marc A Silva

James A Haley Veterans' Hospital

Phone: 813-972-2000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place