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

Congestive Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02312765
• Other study ID #: 820241
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: December 2017

Study information

• Verified date: July 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Congestive heart failure and sleep apnea

Exclusion Criteria:

• Cognitive impairment

Related Conditions & MeSH terms

• Apnea
• Congestive Heart Failure
• Heart Failure
• Sleep Apnea Syndromes

Intervention

Behavioral:
• AirCare App
Tablet software to encourage adherence and support

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	AirCare Labs, LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Adhering to Positive Airway Pressure (PAP)	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