Initiation of CPAP for Newly Diagnosed OSA in Hospitalized Heart Failure Patients
1 other identifier
interventional
13
1 country
1
Brief Summary
The study aimed to examine the effect of Continuous Positive Airway Pressure (CPAP) initiation for newly diagnosed obstructive sleep apnea (OSA) in hospitalized heart failure patients on reducing 30-day hospital readmission rate through a clinical trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 8, 2016
CompletedFirst Submitted
Initial submission to the registry
February 13, 2017
CompletedFirst Posted
Study publicly available on registry
February 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2017
CompletedResults Posted
Study results publicly available
February 16, 2022
CompletedFebruary 16, 2022
January 1, 2022
1.9 years
February 13, 2017
November 5, 2021
January 25, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
All-cause Hospital Readmission Within 30 Days of Hospital Discharge.
Thirty-day hospital readmission will be defined as a hospitalization or visit to the emergency department (ED) for a cardiac cause \> 48 h after discharge. A readmission will be defined as a hospitalization for any reason within 30 days after discharge, and only the first readmission will be counted in case of multiple readmission in the 30-day period.
From hospital discharge to any hospitalization readmission within 30 days from discharge
Study Arms (2)
Continuous Positive Airway Pressure-CPAP
EXPERIMENTALCPAP education and discharge with auto-adjusting Continuous Positive Airway Pressure (CPAP) in addition to usual standards of clinical care for heart failure.
Standard of Care
NO INTERVENTIONCPAP initiation per standard of care based on approval by insurance company and DME company with management as per usual standards of clinical care for heart failure.
Interventions
The auto-CPAP group will be scheduled for follow-up with a phone call at 2 - 3 weeks post discharge, then in sleep medicine clinic at 1 month (+2 weeks) and 6 months (+2 weeks) to assess their progress on CPAP.
Eligibility Criteria
You may qualify if:
- Hospitalized having a documented history of heart failure
- Anticipated hospitalization of more than 24 hours
- Subject has obtained a score of \> 15 on the Ohio Sleep Medicine Institute Preoperative questionnaire.
- Subject has an apnea-hypopneas index (AHI) of \> 5/h as confirmed by sleep medicine physician
You may not qualify if:
- The presence of any conditions that the investigator feels will interfere with the use of CPAP
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
West Virginia University
Morgantown, West Virginia, 26506, United States
Related Publications (1)
Stansbury R, Abdelfattah M, Chan J, Mittal A, Alqahtani F, Sharma S. Hospital screening for obstructive sleep apnea in patients admitted to a rural, tertiary care academic hospital with heart failure. Hosp Pract (1995). 2020 Dec;48(5):266-271. doi: 10.1080/21548331.2020.1799601. Epub 2020 Aug 4.
PMID: 32715796DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Robert Stansbury, MD
- Organization
- West Virginia University
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Stansbury, MD
West Virginia University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Sleep Medicine Fellowship Program Director
Study Record Dates
First Submitted
February 13, 2017
First Posted
February 17, 2017
Study Start
February 8, 2016
Primary Completion
December 31, 2017
Study Completion
December 31, 2017
Last Updated
February 16, 2022
Results First Posted
February 16, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share