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Impact of Early Diagnosis and Treatment of OSA on Hospital Readmission in Hospitalized Cardiac Patients (CV Readmit)

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ClinicalTrials.gov Identifier: NCT03647891
Recruitment Status : Suspended (Study on hold)
First Posted : August 27, 2018
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
Dennis Hwang, MD, Kaiser Permanente

Brief Summary:
The purpose of this study is to determine whether early diagnosis of obstructive sleep apnea and initiation of and adherence to CPAP therapy in hospitalized cardiac patients would impact 30-day hospital readmission rates.

Condition or disease Intervention/treatment Phase
OSA Heart Failure Myocardial Infarction Arrhythmia, Cardiac Device: Continuous Positive Airway Pressure Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of Early Diagnosis and Treatment of Obstructive Sleep Apnea on Hospital Readmission in Hospitalized Cardiac Patients: the CV Readmit Clinical Trial
Estimated Study Start Date : February 28, 2020
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : April 23, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CPAP Intervention Pathway

Patients will receive continuous positive airway pressure (CPAP) therapy in the hospital followed by home CPAP therapy. Their home CPAP therapy will include wireless connectivity, which includes adherence data. Furthermore, the patients will be entered into our usual automated platform (USleep; ResMed Corp) in which patients with suboptimal CPAP use will be sent messages (based on patient preference) in order to ensure adherence to therapy. This platform is already a standard part of our usual care.

The patients will receive CPAP in addition to contemporary standard of care pharmacotherapy for their underlying cardiac condition(s). They will follow up at the Fontana Sleep Center within 1 month after discharge for assessment of CPAP use and asked to complete a questionnaire packet. Patients will be followed during the 30-day period and assessed for readmission rates, time to readmission, adherence to CPAP therapy, and presence of symptoms.

Device: Continuous Positive Airway Pressure
CPAP is an FDA approved therapy machine for patients diagnosed with OSA. CPAP provides positive air pressure to the patients throat to ensure the patients airway stays open during sleep. CPAP is the gold standard treatment for OSA, but there is limited research that demonstrates whether or not CPAP can improve clinical outcomes in patients with cardiovascular disease. Therefore, our investigators plan to initiate CPAP therapy in patients hospitalized for cardiovascular disease to investigate whether there is an improvement in cardiac function and clinical outcomes (e.g. mortality).
Other Names:
  • CPAP
  • APAP

No Intervention: Usual Care Pathway
Patients will receive contemporary standard of care pharmacotherapy for their underlying cardiac condition(s) and will not receive CPAP therapy for the duration of the study. They will be asked to follow up at the Fontana Sleep Center within 1 month after discharge for a repeat outpatient portable sleep study and asked to complete a questionnaire packet. The results of the outpatient portable sleep studies will be compared with the in-patient portable sleep study. Patients will also be asked to follow up with the Fontana Sleep Center within 1 month after discharge for assessment of primary and secondary outcomes. Patients will be followed during the 30-day period and assessed for readmission rates, time to readmission, adherence to CPAP therapy, and presence of symptoms.



Primary Outcome Measures :
  1. Hospital readmission [ Time Frame: 30 days ]
    Number of occasions patient has been admitted to the hospital

  2. Mortality rates [ Time Frame: 30 days ]
    Number of patients who have died


Secondary Outcome Measures :
  1. Clinic and urgent care visits [ Time Frame: 30 days ]
    Appointments with any medical providers (sleep, cardiac, primary) at a clinic or urgent care facility

  2. Off work orders [ Time Frame: 30 days ]
    Note from provider ordering/requesting patient to be dismissed from work for medical reasons (sick, injured, etc.)

  3. STOP BANG [ Time Frame: 30 days ]
    Snoring, tiredness, observed apnea, blood pressure, body mass index, age, neck circumference, and gender (STOP BANG) is the name of a OSA screening questionnaire. Questionnaire contains 8 "Yes/No" questions and the number of "Yes" answers provide a total score (range 0-8). Scores of at least 3 are typically considered to indicate risk of OSA.

  4. Epworth Sleepiness Scale (ESS) [ Time Frame: 30 days ]
    Epworth Sleepiness Scale measures degree of sleepiness. 8 scenarios are described and the responder indicates their likelihood of dozing unintentionally (range 0-3). A total of the scores are added (range 0-24) and typically scores of at least 11 indicate excessive sleepiness.

  5. EQ5D-5L [ Time Frame: 30 days ]
    EuroQoL 5-dimension 5-level measures health-related quality of life that can be used for wide range of health conditions. The questionnaire consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The patients can rate each dimension based on 5 level severity scale: no problems, slight problems, moderate problems, severe problems and extreme problems.This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

  6. PROMIS [ Time Frame: 30 days ]
    Patient Reported Outcome Measurement Information System is a 10 item questionnaire that measures physical, mental, and social health in adults. It can be used on the general population and patients with chronic conditions. Patients rate their health based on a severity scale of 1-5 (1 indicates poor health) and the scoring system allows each question/item to be evaluated separately.

  7. Comparing inpatient portable monitor versus 30-day follow up portable monitor results in usual care group [ Time Frame: 30 days ]
    Evaluating the change of sleep diagnostic test results from the hospital to 1-month after being discharged (only for patients enrolled in the Usual Care pathway)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Kaiser Permanente member
  • Males or female, any race, and age 18 and older
  • OSA-predominant (AHI at or above 5) sleep disordered breathing
  • Primary diagnosis upon admission of congestive heart failure, acute coronary syndrome, or arrhythmias
  • Congestive heart failure (Acute or acute on chronic systolic heart failure, Acute or acute on chronic diastolic heart failure)
  • Acute coronary syndrome (ST segment elevation myocardial infarction, Non-ST segment myocardial infarction, Unstable angina)
  • Arrhythmias (Tachyarrhythmias, Atrial fibrillation, Atrial flutter, Bradyarrhythmias, Sinus bradycardia, 2nd degree atrioventricular block, Complete heart block)
  • Appropriate to perform portable sleep study while on room air (no oxygen)
  • Patients who are able and willing to give informed consent

Exclusion Criteria:

  • Use of CPAP within 6 months of enrollment
  • Patients with CSA-predominant sleep disordered breathing
  • Patients who are "sleepy": ESS at or above 11
  • Commercial driver's license or other occupational hazards (operating heavy machinery)
  • Non-English speaking (validated questionnaires are currently limited to English)
  • Patients with chronic respiratory failure requiring oxygen therapy or non-invasive ventilation.
  • Patients requiring tracheostomy
  • Pregnant patients

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): NCT03647891


Locations
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United States, California
Sleep Center; San Bernardino County Medical Center, Kaiser Permanente
Fontana, California, United States, 92335
Sponsors and Collaborators
Kaiser Permanente
Investigators
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Principal Investigator: Dennis Hwang, MD Fontana Medical Center, Kaiser Permanente

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Responsible Party: Dennis Hwang, MD, Medical Director, Kaiser Permanente
ClinicalTrials.gov Identifier: NCT03647891     History of Changes
Other Study ID Numbers: KPSleep-003
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019

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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

Keywords provided by Dennis Hwang, MD, Kaiser Permanente:
obstructive sleep apnea
CPAP
hospital readmission
heart failure
myocardial infarction
cardiac arrhythmia

Additional relevant MeSH terms:
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Sleep Apnea, Obstructive
Heart Failure
Myocardial Infarction
Arrhythmias, Cardiac
Infarction
Heart Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases