Trial Outcomes & Findings for Obstructive Sleep Apnea Treatment to Improve Cardiac Rehabilitation (NCT NCT02005445)

NCT ID: NCT02005445

Last Updated: 2019-07-05

Results Overview

Functional status as measured by the World Health Organization Disability Assessment Scale 2.0. Score range 0-48 (higher scores indicate more disability).

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 4 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2019-07-05

Participant Flow

Participant milestones

Measure	CPAP Continuous positive airway pressure CPAP: Continuous positive airway pressure	HLSE Healthy living and sleep education HLSE: Healthy living and sleep education
Overall Study STARTED	2	2
Overall Study COMPLETED	2	1
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	CPAP Continuous positive airway pressure CPAP: Continuous positive airway pressure	HLSE Healthy living and sleep education HLSE: Healthy living and sleep education
Overall Study Dual study enrollment	0	1

Baseline Characteristics

Obstructive Sleep Apnea Treatment to Improve Cardiac Rehabilitation

Baseline characteristics by cohort

Measure	CPAP n=2 Participants Continuous positive airway pressure CPAP: Continuous positive airway pressure	HLSE n=2 Participants Healthy living and sleep education HLSE: Healthy living and sleep education	Total n=4 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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
Apnea-hypopnea index	19.7 events/hour n=5 Participants	25.8 events/hour n=7 Participants	19.9 events/hour n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: As we were unable to recruit a sufficient number of patients for meaningful analysis, due to closing of the cardiac Rehabilitation program, no analysis was performed. Because there were only 1-2 participants completing the study in each arm, data are not presented due too confidentiality concerns.

Functional status as measured by the World Health Organization Disability Assessment Scale 2.0. Score range 0-48 (higher scores indicate more disability).

Outcome measures

Outcome data not reported

Adverse Events

CPAP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

HLSE

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	CPAP n=2 participants at risk Continuous positive airway pressure CPAP: Continuous positive airway pressure	HLSE n=2 participants at risk Healthy living and sleep education HLSE: Healthy living and sleep education
Cardiac disorders Chest Pain	0.00% 0/2 • 3 months	50.0% 1/2 • Number of events 1 • 3 months

Additional Information

Dr. Daniel Gottlieb

VA Boston Healthcare System

Phone: 857-203-6375

Email: daniel.gottlieb@va.gov

Results disclosure agreements

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