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

July 27, 2020 updated by: Nalaka Gooneratne, University of Pennsylvania
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

146

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Congestive heart failure and sleep apnea

Exclusion Criteria:

  • Cognitive impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Standard care
Experimental: Intervention
Study participants will receive a tablet computer with the AirCare system.
Behavioral: AirCare App
Tablet software to encourage adherence and support

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Adhering to Positive Airway Pressure (PAP)
Time Frame: 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.
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

AirCare Labs, LLC

Investigators

  • Study Director: Nalaka Gooneratne, MD, University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

December 1, 2014

First Submitted That Met QC Criteria

December 5, 2014

First Posted (Estimate)

December 9, 2014

Study Record Updates

Last Update Posted (Actual)

August 4, 2020

Last Update Submitted That Met QC Criteria

July 27, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 820241

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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