Clinical trial NCT06516354: Evaluation of Obstructive Sleep Apnea (OSA) Using Portable Sleep Testing (PST) Devices on an Inpatient Stroke Unit
Official title: Evaluation of Obstructive Sleep Apnea (OSA) Using Portable Sleep Testing (PST) Devices on an Inpatient Stroke Unit
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2024-07-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* • Acute ischemic stroke (AIS) or transient ischemic attack (TIA) diagnosis during hospitalization

  * Patient on neurology stroke care unit (10 Tower)
  * 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)
  * Positive STOP BANG screen
  * NIHSS 0-25 (higher NIHSS scores may require application of the PST other than by the patient)

Exclusion Criteria:

* • Patients who receive sedation within 24 hours of portable sleep testing

  * Refusal to sign informed consent
  * Non English speaking patient
  * Inability to designate Legally Authorized Representative (LAR) for consent
  * Participation in other ongoing neurothrombectomy research studies
  * Time from symptom onset to emergency department arrival ˃ 72 hours
  * Respiratory distress requiring mechanical ventilation or supplemental oxygen at the time of pre screening
  * Cardiac or respiratory arrest within past 3 months
  * Myocardial infarction (MI) within the past 3 months
  * Any unstable medical condition likely to interfere with participation of portable sleep testing
  * Life expectancy less than 6 months
  * Prior known diagnosis of OSA
  * Currently treated with CPAP device
  * Pregnant and breastfeeding women
  * Prisoners
* Patients unable to complete at least 5 hours of sleep per one night or 8 hours of sleep over 2 nights

Primary outcomes:
measure: STOP BANG tool
timeFrame: 90 days
measure: Portable Sleep Testing
timeFrame: 90 days
Secondary outcomes:
measure: Follow up compliance
timeFrame: 120 days
measure: Follow up readmission rate
timeFrame: 120 days
Other outcomes:
Locations:
city: Park Ridge
country: United States
facility: Advocate Lutheran General Hospital
state: Illinois
Study officials:
affiliation: Advocate Medical Group Neurologist
name: Yelena Tumashova, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Aparicio, HJ. Stroke Unit Evaluation of Sleep Apnea: Validating Screening Tools and the Use of a Portable Sleep Study Device. 2016 International Stroke Conference, Los Angeles, CA 17 Feb 2016 Presentation