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

West Virginia University

Status: Completed

Conditions: Sleep Apnea, Obstructive; Heart Failure

Treatments: Device: Continuous Positive Airway Pressure (CPAP)

Study type: Interventional

Funder types: Other

Identifiers

NCT03056443

WVU02HSC16

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

Continuous Positive Airway Pressure-CPAP

Experimental group

Description:

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

Treatment:

Device: Continuous Positive Airway Pressure (CPAP)

Standard of Care

No Intervention group

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.