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Clinical Trials/NCT02312765
NCT02312765
Completed
Not Applicable

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

University of Pennsylvania0 sites146 target enrollmentNovember 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Congestive Heart Failure
Sponsor
University of Pennsylvania
Enrollment
146
Primary Endpoint
Number of Participants Adhering to Positive Airway Pressure (PAP)
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2014
End Date
December 2017
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nalaka Gooneratne

Associate Professor

University of Pennsylvania

Eligibility Criteria

Inclusion Criteria

  • Congestive heart failure and sleep apnea

Exclusion Criteria

  • Cognitive impairment

Outcomes

Primary Outcomes

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.

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