Impact of Early Diagnosis and Treatment of OSA on Hospital Readmission in Hospitalized Cardiac Patients

NCT03647891 | Suspended FDA Device

• 1 other identifier: KPSleep-003
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

OSA; Heart Failure; Myocardial Infarction; Arrhythmia, Cardiac

Keywords

obstructive sleep apnea; CPAP; hospital readmission; heart failure; myocardial infarction; cardiac arrhythmia

Outcome Measures

Primary Outcomes (2)

• Hospital readmission

  Number of occasions patient has been admitted to the hospital

  30 days

• Mortality rates

  Number of patients who have died

  30 days

Secondary Outcomes (7)

• Clinic and urgent care visits

  30 days

• Off work orders

  30 days

• STOP BANG

  30 days

• Epworth Sleepiness Scale (ESS)

  30 days

• EQ5D-5L

  30 days

Study Arms (2)

CPAP Intervention Pathway

EXPERIMENTAL

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

Usual Care Pathway

NO INTERVENTION

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.

Interventions

Continuous Positive Airway Pressure DEVICE

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).

Also known as: CPAP, APAP

CPAP Intervention Pathway

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Sleep Center; San Bernardino County Medical Center, Kaiser Permanente

Fontana, California, 92335, United States

Location

MeSH Terms

Conditions

Heart Failure; Myocardial Infarction; Arrhythmias, Cardiac; Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Dennis Hwang, MD

  Fontana Medical Center, Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: January 6, 2017
• First Posted: August 27, 2018
• Study Start: July 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: April 1, 2025
• Last Updated: July 6, 2022

Record last verified: 2022-07

Locations

US (1)