Evaluation of Obstructive Sleep Apnea (OSA) Using Portable Sleep Testing (PST) Devices on an Inpatient Stroke Unit

NCT06516354 | Withdrawn FDA Device

• 1 other identifier: AHC6601
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (2)

• STOP BANG tool

  Positive screening on STOP BANG tool for sleep disordered breathing completed during inpatient hospitalization prior to discharge.

  90 days

• Portable Sleep Testing

  Positive screening on Portable Sleep Testing (PST) for sleep disordered breathing completed during inpatient hospitalization prior to discharge.

  90 days

Secondary Outcomes (2)

• Follow up compliance

  120 days

• Follow up readmission rate

  120 days

Study Arms (1)

Portable Sleep Apnea Screening

OTHER

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

Interventions

Portable sleep apnea screening DEVICE

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

Portable Sleep Apnea Screening

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Advocate Lutheran General Hospital

Park Ridge, Illinois, 60068, United States

Location

Related Publications (8)

• Chernyshev OY, McCarty DE, Moul DE, Liendo C, Caldito GC, Munjampalli SK, Kelley RE, Chesson AL Jr. A pilot study: portable out-of-center sleep testing as an early sleep apnea screening tool in acute ischemic stroke. Nat Sci Sleep. 2015 Oct 20;7:127-38. doi: 10.2147/NSS.S85780. eCollection 2015.

  PMID: 26527904 BACKGROUND

• Davis AP, Billings ME, Longstreth WT Jr, Khot SP. Early diagnosis and treatment of obstructive sleep apnea after stroke: Are we neglecting a modifiable stroke risk factor? Neurol Clin Pract. 2013 Jun;3(3):192-201. doi: 10.1212/CPJ.0b013e318296f274.

  PMID: 23914326 BACKGROUND

• Goldstein LB, Bushnell CD, Adams RJ, Appel LJ, Braun LT, Chaturvedi S, Creager MA, Culebras A, Eckel RH, Hart RG, Hinchey JA, Howard VJ, Jauch EC, Levine SR, Meschia JF, Moore WS, Nixon JV, Pearson TA; American Heart Association Stroke Council; Council on Cardiovascular Nursing; Council on Epidemiology and Prevention; Council for High Blood Pressure Research,; Council on Peripheral Vascular Disease, and Interdisciplinary Council on Quality of Care and Outcomes Research. Guidelines for the primary prevention of stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2011 Feb;42(2):517-84. doi: 10.1161/STR.0b013e3181fcb238. Epub 2010 Dec 2.

  PMID: 21127304 BACKGROUND

• Johnson KG, Johnson DC. Frequency of sleep apnea in stroke and TIA patients: a meta-analysis. J Clin Sleep Med. 2010 Apr 15;6(2):131-7.

  PMID: 20411688 BACKGROUND

• Kauta SR, Keenan BT, Goldberg L, Schwab RJ. Diagnosis and treatment of sleep disordered breathing in hospitalized cardiac patients: a reduction in 30-day hospital readmission rates. J Clin Sleep Med. 2014 Oct 15;10(10):1051-9. doi: 10.5664/jcsm.4096.

  PMID: 25317084 BACKGROUND

• King S, Cuellar N. Obstructive Sleep Apnea as an Independent Stroke Risk Factor: A Review of the Evidence, Stroke Prevention Guidelines, and Implications for Neuroscience Nursing Practice. J Neurosci Nurs. 2016 Jun;48(3):133-42. doi: 10.1097/JNN.0000000000000196.

  PMID: 27136407 BACKGROUND

• Redline S, Yenokyan G, Gottlieb DJ, Shahar E, O'Connor GT, Resnick HE, Diener-West M, Sanders MH, Wolf PA, Geraghty EM, Ali T, Lebowitz M, Punjabi NM. Obstructive sleep apnea-hypopnea and incident stroke: the sleep heart health study. Am J Respir Crit Care Med. 2010 Jul 15;182(2):269-77. doi: 10.1164/rccm.200911-1746OC. Epub 2010 Mar 25.

  PMID: 20339144 BACKGROUND

• 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

  RESULT

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Yelena Tumashova, MD

  Advocate Medical Group Neurologist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2018
• First Posted: July 23, 2024
• Study Start: August 1, 2017
• Primary Completion: December 28, 2018
• Study Completion: March 31, 2019
• Last Updated: October 4, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)