Trial Outcomes & Findings for Initiation of CPAP for Newly Diagnosed OSA in Hospitalized Heart Failure Patients (NCT NCT03056443)

Last Updated: 2022-02-16

Results Overview

Thirty-day hospital readmission will be defined as a hospitalization or visit to the emergency department (ED) for a cardiac cause \> 48 h after discharge. A readmission will be defined as a hospitalization for any reason within 30 days after discharge, and only the first readmission will be counted in case of multiple readmission in the 30-day period.

Recruitment status

COMPLETED

Study phase

Target enrollment

13 participants

Primary outcome timeframe

From hospital discharge to any hospitalization readmission within 30 days from discharge

Results posted on

2022-02-16

Participant Flow

No subjects enrolled in arm for no intervention: standard of care.

Participant milestones

Participant milestones
Measure	Continuous Positive Airway Pressure-CPAP CPAP education and discharge with auto-adjusting Continuous Positive Airway Pressure (CPAP) in addition to usual standards of clinical care for heart failure. Continuous Positive Airway Pressure (CPAP): The auto-CPAP group will be scheduled for follow-up with a phone call at 2 - 3 weeks post discharge, then in sleep medicine clinic at 1 month (+2 weeks) and 6 months (+2 weeks) to assess their progress on CPAP.
Overall Study STARTED	13
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Initiation of CPAP for Newly Diagnosed OSA in Hospitalized Heart Failure Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Continuous Positive Airway Pressure-CPAP n=13 Participants CPAP education and discharge with auto-adjusting Continuous Positive Airway Pressure (CPAP) in addition to usual standards of clinical care for heart failure. Continuous Positive Airway Pressure (CPAP): The auto-CPAP group will be scheduled for follow-up with a phone call at 2 - 3 weeks post discharge, then in sleep medicine clinic at 1 month (+2 weeks) and 6 months (+2 weeks) to assess their progress on CPAP.
Age, Continuous	57.9 years n=93 Participants
Sex: Female, Male Female	5 Participants n=93 Participants
Sex: Female, Male Male	8 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants
Race (NIH/OMB) White	12 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Epworth Sleepiness Scale Score	15.4 units on a scale n=93 Participants
Minnesota Heart Failure Questionnaire	71.7 Score on a scale n=93 Participants
Distance Lived from Sleep Center	55.7 Miles n=93 Participants
Apnea Hypopnea Index	16.4 events/hour n=93 Participants

PRIMARY outcome

Timeframe: From hospital discharge to any hospitalization readmission within 30 days from discharge

Population: No subjects enrolled into arm "No intervention: Standard of Care"

Outcome measures

Outcome measures
Measure	Continuous Positive Airway Pressure-CPAP n=13 Participants CPAP education and discharge with auto-adjusting Continuous Positive Airway Pressure (CPAP) in addition to usual standards of clinical care for heart failure. Continuous Positive Airway Pressure (CPAP): The auto-CPAP group will be scheduled for follow-up with a phone call at 2 - 3 weeks post discharge, then in sleep medicine clinic at 1 month (+2 weeks) and 6 months (+2 weeks) to assess their progress on CPAP.
All-cause Hospital Readmission Within 30 Days of Hospital Discharge.	3 readmissions

Adverse Events

Continuous Positive Airway Pressure-CPAP

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Continuous Positive Airway Pressure-CPAP n=13 participants at risk CPAP education and discharge with auto-adjusting Continuous Positive Airway Pressure (CPAP) in addition to usual standards of clinical care for heart failure. Continuous Positive Airway Pressure (CPAP): The auto-CPAP group will be scheduled for follow-up with a phone call at 2 - 3 weeks post discharge, then in sleep medicine clinic at 1 month (+2 weeks) and 6 months (+2 weeks) to assess their progress on CPAP.
General disorders Readmission	7.7% 1/13 • Number of events 1 • 6 months + 2 weeks No subjects were enrolled into arm "No intervention: Standard of Care"

Other adverse events

Adverse event data not reported

Additional Information

Robert Stansbury, MD

West Virginia University

Phone: 304-293-4661

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place