| NCT ID | NCT04130503 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Yale University |
| Condition | Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 360 participants |
| Start Date | 2019-09-01 |
| Primary Completion | 2025-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 360 participants in total. It began in 2019-09-01 with a primary completion date of 2025-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The proposed study is a randomized controlled trial among an anicipated 180 participants with acute ischemic stroke and mod/severe OSA diagnosed by ambulatory polysomnography (PSG) comparing PAP treatment with usual care concerning the primary outcome of functional recovery.
Eligibility Criteria
Inclusion Criteria: * Having an acute ischemic stroke with brain imaging within 48 hours of symptoms onset; * Being within 5 days of neurologic symptoms onset; * Moderate (15 =\< overall AHI \< 30) /severe (overall AHI \>= 30) OSA, thus with an obstructive apnea-hypopnea index AHI \>= 15. Exclusion Criteria: * Past use of prescribed PAP for OSA; * Suspected sleep disorder other than OSA (e.g., narcolepsy) (because such patients should be referred for a formal PSG in a sleep laboratory); * Life expectancy is less than 6 months (e.g., hospice patients); * Patients who require mechanical ventilation (because such patients could not participate in the intervention protocol); * Non-English language patients (because the intervention strategy involves forming a relationship between the patient and research staff); * Central sleep apnea with \> 50% of respiratory events classified as central apnea; * Resting oxygen saturation \< 90%. * Inability to provide their own informed consent. To enhance the generalizability of our study, all stroke severity will be included. However, we will exclude patients who cannot provide their own consent. This is because patients will need to participate actively in the protocol with a behavioral intervention. An assessment of the patient's competence to provide consent will be made based on published recommendations.
Contact & Investigator
Klar Yaggi, MD, MPH
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT04130503 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04130503 currently recruiting?
Yes, NCT04130503 is actively recruiting participants. Contact the research team at radu.radulescu@yale.edu for enrollment information.
Where is the NCT04130503 trial being conducted?
This trial is being conducted at New Haven, United States.
Who is sponsoring the NCT04130503 clinical trial?
NCT04130503 is sponsored by Yale University. The principal investigator is Klar Yaggi, MD, MPH at Yale University. The trial plans to enroll 360 participants.
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