Trial Outcomes & Findings for Telemedicine Interventions for Obstructive Sleep Apnea (OSA) (NCT NCT01108081)

Results Overview

Epworth Sleepiness Scale score, change in score from baseline to 6 months. Total scores range from 0-24, where higher scores indicate more sleepiness.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

169 participants

Primary outcome timeframe

baseline and 6 months

Results posted on

2017-02-10

Participant Flow

Participant milestones

Participant milestones
Measure	Physical Activity Physical activity Physical activity: Moderate-intensity physical activity	Diet Diet Diet: Dietary weight loss	Health Education Health education Health education: Attention control intervention	Combined Physical Activity/Diet Combined physical activity and diet
Overall Study STARTED	46	42	38	43
Overall Study COMPLETED	44	40	38	39
Overall Study NOT COMPLETED	2	2	0	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Telemedicine Interventions for Obstructive Sleep Apnea (OSA)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Physical Activity n=46 Participants Physical activity Physical activity: Moderate-intensity physical activity	Diet n=42 Participants Diet Diet: Dietary weight loss	Health Education n=38 Participants Health education Health education: Attention control intervention	Combined Physical Activity/Diet n=43 Participants Combined physical activity and diet	Total n=169 Participants Total of all reporting groups
Age, Continuous	61.8 years STANDARD_DEVIATION 9.0 • n=5 Participants	60.5 years STANDARD_DEVIATION 8.7 • n=7 Participants	59.1 years STANDARD_DEVIATION 11.0 • n=5 Participants	56.3 years STANDARD_DEVIATION 10.0 • n=4 Participants	59.5 years STANDARD_DEVIATION 9.8 • n=21 Participants
Gender Female	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	5 Participants n=21 Participants
Gender Male	44 Participants n=5 Participants	42 Participants n=7 Participants	38 Participants n=5 Participants	40 Participants n=4 Participants	164 Participants n=21 Participants

PRIMARY outcome

Timeframe: baseline and 6 months

Population: Two participants did not complete the questionnaire and therefore had missing Epworth Sleepiness Scale scores. One participant in Diet arm and one participant in Health education arm.

Epworth Sleepiness Scale score, change in score from baseline to 6 months. Total scores range from 0-24, where higher scores indicate more sleepiness.

Outcome measures

Outcome measures
Measure	Physical Activity n=44 Participants Physical activity Physical activity: Moderate-intensity physical activity	Diet n=39 Participants Diet Diet: Dietary weight loss	Health Education n=37 Participants Health education Health education: Attention control intervention	Combined Physical Activity/Diet n=39 Participants Combined physical activity and diet
Change Over 6 Months in Epworth Sleepiness Scale Score	-0.23 units on a scale Standard Error 0.69	-1.05 units on a scale Standard Error 0.38	0.43 units on a scale Standard Error 0.66	-2.62 units on a scale Standard Error 0.59

SECONDARY outcome

Timeframe: baseline and 6 months

Population: Two participants did not complete the questionnaire and therefore had missing Functional Outcomes of Sleep Questionnaire scores. One participant in Diet arm and one participant in Health education arm.

Quality of life as assessed by the Functional Outcomes of Sleep Questionnaire, change from baseline to 6 months. The potential range of scores for the Functional Outcomes of Sleep total score is 5-20 where higher scores indicate better quality of life. The total score is the sum of the 5 subscale scores (general productivity, social outcome, activity level, vigilance, intimate relationships), which are weighted means ranging from 1-4.

Outcome measures

Outcome measures
Measure	Physical Activity n=44 Participants Physical activity Physical activity: Moderate-intensity physical activity	Diet n=39 Participants Diet Diet: Dietary weight loss	Health Education n=37 Participants Health education Health education: Attention control intervention	Combined Physical Activity/Diet n=39 Participants Combined physical activity and diet
Change Over 6 Months in Quality of Life	0.24 units on a scale Standard Error 0.44	0.15 units on a scale Standard Error 0.24	-0.33 units on a scale Standard Error 0.28	1.24 units on a scale Standard Error 0.42

Adverse Events

Physical Activity

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Diet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Health Education

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Combined Physical Activity/Diet

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. David Sparrow

VA Boston Healthcare System

Phone: 857-364-6400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place