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

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ClinicalTrials.gov Identifier: NCT03056443
Recruitment Status : Active, not recruiting
First Posted : February 17, 2017
Last Update Posted : May 28, 2018
Sponsor:
Collaborator:
West Virginia Clinical and Translational Science Institute
Information provided by (Responsible Party):
West Virginia University

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.

Condition or disease Intervention/treatment Phase
Sleep Apnea, Obstructive Heart Failure Device: Continuous Positive Airway Pressure (CPAP) Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Initiation of CPAP for Newly Diagnosed OSA in Hospitalized Heart Failure Patients: A Randomized Clinical Trial
Actual Study Start Date : February 8, 2016
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Continuous Positive Airway Pressure-CPAP
CPAP education and discharge with auto-adjusting Continuous Positive Airway Pressure (CPAP) in addition to usual standards of clinical care for heart failure.
Device: Continuous Positive Airway Pressure (CPAP)
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.

No Intervention: Standard of Care
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.



Primary Outcome Measures :
  1. All-cause hospital readmission within 30 days of hospital discharge. [ Time Frame: From hospital discharge to any hospitalization readmission within 30 days from 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03056443


Locations
United States, West Virginia
West Virginia University
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
West Virginia University
West Virginia Clinical and Translational Science Institute
Investigators
Principal Investigator: Robert Stansbury, MD West Virginia University

Responsible Party: West Virginia University
ClinicalTrials.gov Identifier: NCT03056443     History of Changes
Other Study ID Numbers: WVU02HSC16
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: May 28, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
Heart Failure
Sleep Apnea, Obstructive
Heart Diseases
Cardiovascular Diseases
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases