Heart Failure, Sleep Apnea, Obstructive
Conditions
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.
Interventions
DEVICEContinuous 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.
Sponsors
West Virginia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause Hospital Readmission Within 30 Days of Hospital Discharge. | 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. |
Countries
United States
Participant flow
Pre-assignment details
No subjects enrolled in arm for no intervention: standard of care.
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 13 |
| Total | 13 |
Baseline characteristics
| Characteristic | Continuous Positive Airway Pressure-CPAP |
|---|---|
| Age, Continuous | 57.9 years |
| Apnea Hypopnea Index | 16.4 events/hour |
| Distance Lived from Sleep Center | 55.7 Miles |
| Epworth Sleepiness Scale Score | 15.4 units on a scale |
| Minnesota Heart Failure Questionnaire | 71.7 Score on a scale |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 13 |
| other Total, other adverse events | 0 / 13 |
| serious Total, serious adverse events | 2 / 13 |
Outcome results
Primary
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.
Time frame: From hospital discharge to any hospitalization readmission within 30 days from discharge
Population: No subjects enrolled into arm No intervention: Standard of Care
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Continuous Positive Airway Pressure-CPAP | All-cause Hospital Readmission Within 30 Days of Hospital Discharge. | 3 readmissions |