Clinical Trial Details
— Status: Suspended
Administrative data
| NCT number |
NCT03647891 |
| Other study ID # |
KPSleep-003 |
| Secondary ID |
|
| Status |
Suspended |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 2023 |
| Est. completion date |
April 2025 |
Study information
| Verified date |
July 2022 |
| Source |
Kaiser Permanente |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Study investigators have designed a single-center, randomized control trial to evaluate the
impact of early diagnosis and treatment of obstructive sleep apnea (OSA) in hospitalized
cardiac patients on hospital readmission, symptoms, and healthcare utilization. This study
targets a high risk population (hospitalized cardiac patients) and targets early initiation
of continuous positive airway pressure (CPAP) therapy in patients diagnosed with OSA.
Investigators intend to enroll all consenting participants hospitalized with a primary
cardiac diagnosis, which include congestive heart failure, arrhythmia's, and acute coronary
syndromes. The study is unique and the answer to its question - whether early diagnosis of
OSA and initiation of and adherence to CPAP therapy in hospitalized cardiac patients will
reduce 30-day readmission rates - is unknown. The objective is twofold: to improve quality of
care and decrease preventable hospitalizations through early diagnosis and implementation of
this early diagnosis and intervention model for this subset of patients may slow progression
of cardiac disease, offset a large public health and financial burden, and improve overall
outcomes.
Study investigators believe that the study, which involves human subjects, is in accordance
with general ethical principles. It should be noted that diagnosis and subsequent treatment
of OSA during hospitalization is not part of routine practice, and that the control group
truly would follow "usual care". Moreover, patients who are deemed very sick (as outlined in
the exclusion criteria) will be excluded from the study. Finally, half of enrolled
participants will receive early CPAP therapy which may potentially benefit those patients
beyond what is currently "usual care".
Study Design
The study is a single-center, randomized control trial designed to evaluate the impact of
early diagnosis and treatment of obstructive sleep apnea (OSA) in hospitalized cardiac
patients on hospital readmission, symptoms, and healthcare utilization. Consecutive patients
who meet inclusion criteria hospitalized with a primary diagnosis of heart failure,
arrhythmia, or acute coronary syndrome will be asked to participate in the study. Patients
who agree and sign consent will undergo a portable sleep study to diagnose OSA-predominant
sleep disordered breathing. Patients will also complete a questionnaire packet consisting of
the following standardized questionnaires: sleep history questionnaire, Epworth Sleepiness
Scale (ESS), EQ5D-5L, and PROMIS questionnaire. Each patient who meets inclusion criteria and
consents to the study will undergo an inpatient portable sleep study (ApneaLink, Resmed
Corp). This is a Type III study which is an unattended study that measures nasal pressure,
respiratory effort, oxygen saturation, and body position. A study investigator will apply the
portable device, and a board-certified sleep medicine physician (co-investigators) will
interpret these studies. The study will be performed while the patient is on room air (not on
oxygen), thus the study may not be applied on the first hospitalized night (if oxygen therapy
is required), but delayed until the patient is appropriate to be off oxygen.
A diagnosis of OSA will be made if the apnea-hypopnea index with 4% oxygen desaturation is
greater than 5 (AHI4%≥5) with at least 50% of events consistent with obstructive rather than
central physiology. Study participants with OSA will then be randomized into one of two
pathways: Intervention Pathway and Usual Care Pathway.
Intervention Pathway Patients will receive CPAP therapy in the hospital followed by home CPAP
therapy. A sleep center respiratory therapy/sleep technologist case manager will perform a
bedside mask fit, CPAP education, and set up their outpatient follow-up appointments with the
sleep center. Their home CPAP therapy will be a loaner from the sleep medicine department
that includes wireless connectivity so that adherence data is available to the investigators
throughout the duration of the study. 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 (email or text 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 the contemporary standard of care
pharmacotherapy for their underlying cardiac condition(s). They will be asked to follow up at
the Fontana Sleep Center within 1 month after discharge for assessment of CPAP use and asked
to complete the aforementioned questionnaire packet (with the exception of the STOP BANG
questionnaire). During the appointment, the sleep center will troubleshoot CPAP use when
appropriate; otherwise, requests for additional troubleshooting will be at the discretion of
the patient (as is currently our usual care). In addition, patients will receive a $50
stipend for participation in the study. Patients will be assessed for readmission rates, time
to readmission, adherence to CPAP therapy, and presence of symptoms at the 1-month period
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 the
aforementioned questionnaire packet (with the exception of the STOP BANG questionnaire). The
results of the outpatient portable sleep studies will be compared with the in-patient
portable sleep study. At the one-month follow up appointment, patients will receive a $50
stipend for participation in the study. Patients will be assessed for readmission rates, time
to readmission, adherence to CPAP therapy, and presence of symptoms at the 1-month period
