Trial Outcomes & Findings for Telecommunications System in Sleep Apnea (NCT NCT00232544)

NCT ID: NCT00232544

Last Updated: 2018-10-10

Results Overview

Mean nightly hours of CPAP use over 12 months

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 250 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2018-10-10

Participant Flow

Participant milestones

Measure	TLC-CPAP A telephone-linked communication (TLC) system for promoting adherence to continuous positive airway pressure (CPAP)	TLC-Control A TLC system for providing general health education
Overall Study STARTED	124	126
Overall Study COMPLETED	104	111
Overall Study NOT COMPLETED	20	15

Reasons for withdrawal

Measure	TLC-CPAP A telephone-linked communication (TLC) system for promoting adherence to continuous positive airway pressure (CPAP)	TLC-Control A TLC system for providing general health education
Overall Study Lost to Follow-up	20	15

Baseline Characteristics

Telecommunications System in Sleep Apnea

Baseline characteristics by cohort

Measure	TLC-CPAP n=124 Participants A telephone-linked communication (TLC) system for promoting adherence to continuous positive airway pressure (CPAP)	TLC-Control n=126 Participants A TLC system for providing general health education	Total n=250 Participants Total of all reporting groups
Age, Continuous	56 years n=5 Participants	54 years n=7 Participants	55 years n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	21 Participants n=7 Participants	45 Participants n=5 Participants
Sex: Female, Male Male	100 Participants n=5 Participants	105 Participants n=7 Participants	205 Participants n=5 Participants
Region of Enrollment United States	124 participants n=5 Participants	126 participants n=7 Participants	250 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Mean nightly hours of CPAP use over 12 months

Outcome measures

Measure	TLC-CPAP n=104 Participants A telephone-linked communication (TLC) system for promoting adherence to continuous positive airway pressure (CPAP)	TLC-Control n=111 Participants A TLC system for providing general health education
Objective CPAP Use	0.437 log(hours/night) Interval 0.165 to 0.708	-0.066 log(hours/night) Interval -0.376 to 0.243

SECONDARY outcome

Timeframe: 12 months

A measure of behavioral alertness. Specifically the metric we used was the mean reaction time, the time it took for a subject to respond to a visual stimulus (light displayed on a screen at random intervals) by hitting a button.

Outcome measures

Measure	TLC-CPAP n=104 Participants A telephone-linked communication (TLC) system for promoting adherence to continuous positive airway pressure (CPAP)	TLC-Control n=111 Participants A TLC system for providing general health education
Daytime Vigilance	293.7 ms Interval 279.9 to 307.6	324.0 ms Interval 302.2 to 345.8

Adverse Events

TLC-CPAP

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

TLC-Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	TLC-CPAP n=124 participants at risk A telephone-linked communication (TLC) system for promoting adherence to continuous positive airway pressure (CPAP)	TLC-Control n=126 participants at risk A TLC system for providing general health education
Gastrointestinal disorders Death	0.81% 1/124 • Number of events 1	0.00% 0/126

Other adverse events

Adverse event data not reported

Additional Information

Dr. David Sparrow

VA Boston Healthcare System

Phone: 857-364-6407

Email: david.sparrow@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place