Reducing Heart Failure Re-admissions by Enhancing Sleep Apnea Treatment Adherence

Not Applicable

Completed

• Conditions: Congestive Heart Failure; Sleep Apnea Syndromes
• Interventions: Behavioral: AirCare App

• Registration Number: NCT02312765
• Lead Sponsor: University of Pennsylvania

Brief Summary

Sleep apnea, characterized by abnormal breathing at night, is often untreated in patients with heart failure. Helping patients to effectively use the most common form of treatment for sleep apnea, positive airway pressure therapy, can improve their heart function. This can reduce the likelihood that the patient will be re-admitted to the hospital. AirCareLabs has developed an innovative solution that allows patients to communicate with health care providers 24 hours a day, thus allowing them to get the help they need to effectively use positive airway pressure and thereby reduce the risk of being re-admitted to the hospital.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-12-01
• Study First Submitted QC: 2014-12-05
• Study First Posted: 2014-12-09
• Primary Completion: 2017-06
• Study Completion: 2017-12
• Results First Submitted: 2019-08-28
• Status Verified: 2020-07
• Results First Submitted QC: 2020-07-27
• Last Update Submitted: 2020-07-27
• Results First Posted: 2020-08-04
• Last Update Posted: 2020-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

• Congestive heart failure and sleep apnea

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Exclusion Criteria

• Cognitive impairment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	AirCare App	Study participants will receive a tablet computer with the AirCare system.

Primary Outcome Measures

Name	Time	Method
Number of Participants Adhering to Positive Airway Pressure (PAP)	one month	PAP adherence will be measured from the PAP unit (which monitors nightly hours of use and records this data; this is the standard of care clinical practice approach used currently by health care providers to monitor PAP use) and will be reported as Number of Participants who Adhered to Positive Airway Pressure (PAP) Treatment (adherence defined as \>4 hours of use per night on average across the 30 day period). For example, if 5 subjects used PAP for more than 4 hours per night on average across the 30 day period, then the number of adherent participants is 5.