No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
360 (estimated)
Sponsor
Yale University · Other
Who this trial is looking for
This trial is looking for people who have had an acute stroke and also have moderate to severe obstructive sleep apnea. Participants will receive PAP treatment and be monitored for their recovery compared to usual care.
Are You a Good Fit for This Trial?
You may be able to join if
I have had an acute ischemic stroke within the last 48 hours.
I have symptoms that started less than 5 days ago.
I have moderate to severe obstructive sleep apnea.
You may not be able to join if
I have used prescribed PAP for sleep apnea before.
I have a sleep disorder other than obstructive sleep apnea.
My life expectancy is less than 6 months.
I need mechanical ventilation.
I do not speak English.
I have central sleep apnea with more than 50% central apnea events.
My resting oxygen saturation is below 90%.
I cannot provide my own informed consent.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Status
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.
Exclusio…
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.
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