Improving recovery in stroke patients with sleep apnea using PAP treatment
The Recovery in Stroke Using PAP Study
This study is testing if using a special breathing machine can help stroke patients with sleep apnea recover better and improve their quality of life compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT04130503 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a randomized controlled trial involving approximately 180 participants who have experienced an acute ischemic stroke and have moderate to severe obstructive sleep apnea (OSA). The study aims to compare the effectiveness of positive airway pressure (PAP) treatment against usual care in improving functional recovery, stroke severity, and quality of life. Additionally, it will explore the timing of PAP initiation and gather qualitative insights from patients and caregivers about their experiences with the treatment. The study also seeks to evaluate the prognostic value of sleep study measures in stroke recovery.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals who have had an acute ischemic stroke within the last 5 days and are diagnosed with moderate to severe obstructive sleep apnea.
Not a fit: Patients who have previously used prescribed PAP for OSA or have other sleep disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly enhance recovery outcomes for stroke patients suffering from obstructive sleep apnea.
How similar studies have performed: Other studies have shown promising results in improving outcomes for stroke patients with sleep apnea using similar treatment approaches.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New Haven, Connecticut
- Yale University — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Klar Yaggi, MD, MPH — Yale University
- Study coordinator: Radu Radulescu, MD
- Email: radu.radulescu@yale.edu
- Phone: 2033614037
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.