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Initiation of CPAP for Newly Diagnosed OSA in Hospitalized Heart Failure Patients

Primary Purpose

Sleep Apnea, Obstructive, Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuous Positive Airway Pressure (CPAP)
Sponsored by
West Virginia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea, Obstructive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • The presence of any conditions that the investigator feels will interfere with the use of CPAP

Sites / Locations

  • West Virginia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Continuous Positive Airway Pressure-CPAP

Standard of Care

Arm Description

CPAP education and discharge with auto-adjusting Continuous Positive Airway Pressure (CPAP) in addition to usual standards of clinical care for heart failure.

CPAP 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 13, 2017
Last Updated
January 25, 2022
Sponsor
West Virginia University
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1. Study Identification

Unique Protocol Identification Number
NCT03056443
Brief Title
Initiation of CPAP for Newly Diagnosed OSA in Hospitalized Heart Failure Patients
Official Title
Initiation of CPAP for Newly Diagnosed OSA in Hospitalized Heart Failure Patients: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
February 8, 2016 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West Virginia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Following consent adult patients hospitalized with a medical history of heart failure and meeting study eligibility criteria will be screened for obstructive sleep apnea using the Ohio Sleep Medicine Institute Preoperative Questionnaire. If the probability of sleep apnea is high (Sleep apnea clinical Score >15) then participants will complete the Epworth Daytime Sleepiness scale and the Minnesota Living with HeartFailure questionnaire. The patient will then be evaluated by the sleep medicine team with a portable polysomnography monitor which has been shown to be equivalent to standard in-laboratory polysomnography. All participants with apnea-hypopnea index (AHI) ≥ 5events/h in whom sleep disordered breathing is confirmed by sleep medicine physician will be eligible for randomization. Participants will be randomized into an auto-adjusting Continuous Positive Airway Pressure (CPAP) group or standard of care (control) group. CPAP Arm (Intervention): CPAP education and discharge with auto-adjusting Continuous Positive Airway Pressure (CPAP) in addition to usual standards of clinical care for heart failure. 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. Standard of Care Arm (Comparator): CPAP 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. This group will be scheduled for follow-up with a phone call at 2- 3 weeks post discharge and then in sleep medicine clinic at 1 month (+2 weeks) and 6 months (+2 weeks) to assess their progress.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive, Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous Positive Airway Pressure-CPAP
Arm Type
Experimental
Arm Description
CPAP education and discharge with auto-adjusting Continuous Positive Airway Pressure (CPAP) in addition to usual standards of clinical care for heart failure.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
CPAP 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.
Intervention Type
Device
Intervention Name(s)
Continuous Positive Airway Pressure (CPAP)
Intervention Description
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.
Primary Outcome Measure Information:
Title
All-cause Hospital Readmission Within 30 Days of Hospital Discharge.
Description
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.
Time Frame
From hospital discharge to any hospitalization readmission within 30 days from discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: The presence of any conditions that the investigator feels will interfere with the use of CPAP
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Stansbury, MD
Organizational Affiliation
West Virginia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Virginia University
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32715796
Citation
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.
Results Reference
derived

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Initiation of CPAP for Newly Diagnosed OSA in Hospitalized Heart Failure Patients

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