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Patients With Heart Failure With Preserved Ejection Fraction Adherence to ASV Therapy (PEP ASV)

NCT04133350 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2021-05-27

No results posted yet for this study

Summary

This is a prospective, single-arm, unblinded pilot study and registry that aims to demonstrate adherence to adaptive servo-ventilation (ASV) therapy in patients with moderate to severe sleep disordered breathing who have been recently hospitalized. ASV therapy has been linked to improved outcomes in this population, but adherence to therapy is low. The AirCurve 10 ASV device that will be used for this study employs newer technologies, such as web-based monitoring and provides patients feedback, which may increase therapy adherence and therefore improve patient outcomes.

Conditions

Interventions

BEHAVIORAL

Active Patient Engagement

The APE intervention will be delivered through a patient-facing application and website called myAir, which provides patients with access to their own usage data, educational tips, and coaching.

Sponsors & Collaborators

  • Inova Fairfax Hospital

    collaborator OTHER

  • Heart and Diabetes Center North Rhine-Westphalia

    collaborator OTHER

  • CLEMENS HOSPITAL

    collaborator UNKNOWN

  • Resmed Inc

    collaborator UNKNOWN

  • Thomas Jefferson University

    lead OTHER

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-16
Primary Completion
2021-02-01
Completion
2021-02-01

Countries

  • United States
  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04133350 on ClinicalTrials.gov