An interventional study of Portable sleep apnea screening in Obstructive Sleep Apnea, sponsored by Wake Forest University Health Sciences. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-04.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Screening
The purpose of this study is to evaluate the feasibility of testing patients for OSA within the inpatient setting. As part of this program, the investigators are proposing early access to a sleep apnea treatment plan, potentially lowering the risk for future stroke symptoms, and preventing lost to follow up of patients for treatment since sleep disordered breathing is primarily considered a disorder that is managed in an outpatient setting.
Hypothesis: Early identification of sleep apnea as a modifiable stroke risk factor (SRF) for acute ischemic stroke (AIS) and transient ischemic attack (TIA) patients using the STOP BANG questionnaire and portable sleep testing (PST) during inpatient hospitalization, will allow early identification of patients at risk for sleep disordered breathing, early diagnosis of sleep apnea, and earlier prescribed treatment prior to discharge.
Currently the standard of care at Lutheran General Hospital for patients does not include a STOP BANG pre-screening assessment, and portable sleep testing (PST) to identify sleep disordered breathing as a risk factor for AIS and TIA. Initially, patients will be asked questions if they have a history of OSA diagnosis, and if ever have been treated with a form of PAP. If the response is no, then the patient will be prescreened using the STOP BANG assessment tool and review of eligibility requirements. If positive STOP BANG and patient meets eligibility, the patient will have the PST device registered and the Watermark ARES 610 will be applied by the sub investigators. The patient will then undergo a portable sleep study which measures nasal pressure, respiratory effort, oxygen saturation, electrocardiogram and body position. If the device needs adjustment during sleep it can be adjusted by patient or Nursing Care Technician. The next morning the PST device, which is removed by sub investigators, will be delivered to the Sleep Laboratory, downloaded by the sleep technician in Sleep Lab, and data transmitted via the hospital network to the sleep specialist (Primary Investigator) for interpretation. If the PST study is interpreted as positive this will initiate a treatment plan by the sleep specialist for prescription of PAP and/or follow up. This patient who is positive will not require an additional polysomnogram for confirmation of the sleep apnea in the outpatient setting. If the result is inconclusive, but highly suspicious, this may require additional outpatient testing.
2,263 studies on the registry are indexed under Sleep Apnea, Obstructive; 465 are open to participants now.
Browse Sleep Apnea, Obstructive studies →Wake Forest University Health Sciences is the lead sponsor of 1,345 studies on the registry; 198 are open to participants now.
Of its 328 completed or terminated interventional studies of FDA-regulated products, 249 (76%) have results posted.
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Acute ischemic stroke (AIS) or transient ischemic attack (TIA) diagnosis during hospitalization
Consenting adults (≥ 18 years old)
o For subjects unable to effectively communicate or sign consent due to stroke symptoms, informed consent will be obtained from LAR (legally authorized representative)
Exclusion Criteria:
Patients who receive sedation within 24 hours of portable sleep testing
Application of portable sleep apnea screening device on inpatient stroke/TIA patients for at least 5 hours of sleep in one night or 8 hours of sleep over 2 consecutive nights.
Device: Portable sleep apnea screening
Screening of stroke and TIA patients on the stroke inpatient unit using theSTOP BANG questionnaire and portable sleep testing (PST) during inpatient hospitalization, early interpretation of PST results by neurology with prescribed treatment upon discharge from hospital
STOP BANG tool
Positive screening on STOP BANG tool for sleep disordered breathing completed during inpatient hospitalization prior to discharge.
Time frame: 90 days
Portable Sleep Testing
Positive screening on Portable Sleep Testing (PST) for sleep disordered breathing completed during inpatient hospitalization prior to discharge.
Time frame: 90 days
Follow up compliance
Phone call with patient to assess compliance and tolerability to treatment plan
Time frame: 120 days
Follow up readmission rate
Hospital readmission due to stroke from the Crimson database
Time frame: 120 days
Plan to share: No
Started Aug 2017 (actual). Primary completion is estimated for Dec 2018, 16 months after the start.
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This study is withdrawn, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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