BridgeMD
New treatment option for Ischemic Stroke
Official title The Recovery in Stroke Using PAP Study
ClinicalTrials.gov ID: NCT04130503
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Having an acute ischemic stroke with brain imaging within 48 hours of symptoms onset;
- Being within 5 days of neurologic symptoms onset;
- Moderate (15 =\ = 30) OSA, thus with an obstructive apnea-hypopnea index AHI \>= 15.
You likely can't join if
- 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;
See the full eligibility 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 =\ = 30) OSA, thus with an obstructive apnea-hypopnea index AHI \>= 15.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.