Initiation of CPAP for Newly Diagnosed OSA in Hospitalized Heart Failure Patients
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Insomnia Sleep Studies, Cardiology, Pulmonary |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/30/2019 |
| Start Date: | February 8, 2016 |
| End Date: | December 31, 2019 |
Initiation of CPAP for Newly Diagnosed OSA in Hospitalized Heart Failure Patients: A Randomized Clinical Trial
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.
initiation for newly diagnosed obstructive sleep apnea (OSA) in hospitalized heart failure
patients on reducing 30-day hospital readmission rate through a clinical trial.
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.
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.
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
We found this trial at
1
site
Morgantown, West Virginia 26506
(304) 293-0111
Principal Investigator: Robert Stansbury, MD
Phone: 304-581-1749
West Virginia University West Virginia University, founded in 1867, has a long and rich history...
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