Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06516354
Status:
WITHDRAWN
Last Update Posted:
None
First Post:
2018-02-21
Brief Title:
Evaluation of Obstructive Sleep Apnea OSA Using Portable Sleep Testing PST Devices on an Inpatient Stroke Unit
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Obstructive Sleep Apnea OSA Using Portable Sleep Testing PST Devices on an Inpatient Stroke Unit
Status:
WITHDRAWN
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low enrollment no patients were enrolled
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OSA
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
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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None