Obstructive Sleep ApneaOSANCT06516354
Evaluation of Obstructive Sleep Apnea (OSA) Using Portable Sleep Testing (PST) Devices on an Inpatient Stroke Unit
A study testing Portable sleep apnea screening in people with Obstructive Sleep Apnea, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Portable sleep apnea screening
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 31 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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)
Who cannot join
- • 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Advocate Lutheran General Hospital
Park Ridge, Illinois, 60068
About this study
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Portable sleep apnea screening
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portable sleep apnea screeningDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Portable sleep apnea screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
STOP BANG tool
Positive screening on STOP BANG tool for sleep disordered breathing completed during inpatient hospitalization prior to discharge.
Measured: 90 days
Portable Sleep Testing
Positive screening on Portable Sleep Testing (PST) for sleep disordered breathing completed during inpatient hospitalization prior to discharge.
Measured: 90 days
Secondary outcomes (2)
Follow up compliance
Phone call with patient to assess compliance and tolerability to treatment plan
Measured: 120 days
Follow up readmission rate
Hospital readmission due to stroke from the Crimson database
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start1 Aug 2017
- Primary completion28 Dec 2018 (estimated)
- Study completion31 Mar 2019 (estimated)
Why it stopped: Low enrollment; no patients were enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yelena Tumashova, MD, Principal investigator, Advocate Medical Group Neurologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06516354
- Sponsor's protocol ID
- AHC6601
- Acronym
- OSA
- Status last verified
- Sep 2024
- First submitted
- 21 Feb 2018
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 26527904Davis 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.
PubMed 23914326Goldstein 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.
PubMed 21127304Johnson 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.
PubMed 20411688Kauta 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.
PubMed 25317084King 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.
PubMed 27136407Redline 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.
PubMed 20339144Aparicio, 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Obstructive Sleep Apnea (OSA) Using Portable Sleep Testing (PST) Devices on an Inpatient Stroke Unit
- ClinicalTrials.gov ID
- NCT06516354
- Acronym / sponsor ID
- OSA / AHC6601
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Low enrollment; no patients were enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 28 Dec 2018 (estimated)
- Study completion
- 31 Mar 2019 (estimated)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Portable Sleep Apnea Screening | Other | Device: Portable sleep apnea screeningApplication 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- • Acute ischemic stroke (AIS) or transient ischemic attack (TIA) diagnosis during hospitalization
- o For subjects unable to effectively communicate or sign consent due to stroke symptoms, informed consent will be obtained from LAR (legally authorized representative)
Key exclusion criteria (16 listed)
- • Patients who receive sedation within 24 hours of portable sleep testing
- Patients unable to complete at least 5 hours of sleep per one night or 8 hours of sleep over 2 nights
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Portable sleep apnea screeningScreening 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 | Device | Portable Sleep Apnea Screening |
Primary outcome
STOP BANG tool
Time frame: 90 days
Positive screening on STOP BANG tool for sleep disordered breathing completed during inpatient hospitalization prior to discharge.
Portable Sleep Testing
Time frame: 90 days
Positive screening on Portable Sleep Testing (PST) for sleep disordered breathing completed during inpatient hospitalization prior to discharge.
2 secondary outcomes
Follow up compliance
Time frame: 120 days
Follow up readmission rate
Time frame: 120 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Background: PubMed 26527904Chernyshev 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.
- Background: PubMed 23914326Davis 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.
- Background: PubMed 21127304Goldstein 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.
- Background: PubMed 20411688Johnson 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.
- Background: PubMed 25317084Kauta 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.
- Background: PubMed 27136407King 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.
- Background: PubMed 20339144Redline 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.
- Results publicationAparicio, 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
- Individual participant dataSharing planned: No
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Clinical Validation of Artificial Intelligence Algorithms for Sleep Staging and Obstructive Sleep Apnea Screening Based on a Large-Scale Model Trained on Multimodal Physiological Signals From Diverse Populations
Sleep Apnea, Obstructive, Sleep Staging
RecruitingObservational study
Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
Pediatric Obstructive Sleep Apnea
Not yet recruiting
Effect of High-flow Nasal Cannula Oxygenation on the Incidence of Hypoxemia During Painless Gastrointestinal Endoscopy in Patients at High Risk for Obstructive Sleep Apnea Syndrome in High-altitude Regions
Hypoxemia, Gastric Cancer (Diagnosis)
Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression
Enrolling by invitation
Myofunctional Therapy for Obstructive Sleep Apnea
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yelena Tumashova, MD principal investigator
Advocate Medical Group Neurologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Portable sleep apnea screening in people with Obstructive Sleep Apnea, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
STOP BANG tool (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06516354, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.