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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Continuous Positive Airway Pressure-CPAP | Experimental | CPAP education and discharge with auto-adjusting Continuous Positive Airway Pressure (CPAP) in addition to usual standards of clinical care for heart failure. |
|
| Standard of Care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous Positive Airway Pressure (CPAP) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From hospital discharge to any hospitalization readmission within 30 days from discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Stansbury, MD | West Virginia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Virginia University | Morgantown | West Virginia | 26506 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32715796 | Derived | 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. |
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No subjects enrolled in arm for no intervention: standard of care.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
No subjects enrolled into arm "No intervention: Standard of Care"
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | No subjects enrolled into arm "No intervention: Standard of Care" | Posted | Number | readmissions | From hospital discharge to any hospitalization readmission within 30 days from discharge |
|
6 months + 2 weeks
No subjects were enrolled into arm "No intervention: Standard of Care"
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Readmission | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Stansbury, MD | West Virginia University | 304-293-4661 | rstansbury@hsc.wvu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 27, 2016 | Aug 4, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Epworth Sleepiness Scale Score | 0-5 Lower Normal Daytime Sleepiness 6-10 Higher Normal Daytime Sleepiness 11-12 Mild Excessive Daytime Sleepiness 13-15 Moderate Excessive Daytime Sleepiness 16-24 Severe Excessive Daytime Sleepiness | Median | Full Range | units on a scale |
|
| Minnesota Heart Failure Questionnaire | Minnesota Living with Heart Failure Questionnaire (MLHFQ) will be used to determine the disease-specific quality of life. It has 21 items in physical, emotional and socioeconomic dimensions; each item scored from 0 to 5 [For each question the answer may vary from 0 (no), 1 (very little) to 5 (very much)] provides a total score between 0 to 105: the higher the score, the lower quality of life. | Median | Full Range | Score on a scale |
|
| Distance Lived from Sleep Center | Median | Full Range | Miles |
|
| Apnea Hypopnea Index | Median | Full Range | events/hour |
|
|
|
| 0 |
| 13 |
| 2 |
| 13 |
| 0 |
| 13 |
| Readmission | General disorders | Non-systematic Assessment | Morphine Overdose |
|
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| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D012138 |
| Respiratory Therapy |