Image

The Recovery in Stroke Using PAP Study

The Recovery in Stroke Using PAP Study

Recruiting
18 years and older
All
Phase N/A

Powered by AI

Overview

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.

Description

This study has 4 aims: 3 main aims and an additional exploratory aim.

Specific aim 1: Test whether PAP treatment for OSA in ischemic stroke improves stroke severity, post-stroke symptoms, post-stroke functional recovery (primary outcome), and quality of life.

Specific aim 2: Determine whether acute vs. subacute initiation of PAP in ischemic stroke results in greater improvement in post-stroke outcomes (stroke severity, symptoms, stroke recovery, quality of life).

Specific Aim 3: Conduct in-depth qualitative interviews with 25-30 stroke patients, family members, and acute care providers to elicit their experience with PAP use, including factors that influence adherence.

Exploratory aim: Evaluate whether polysomnographic measures have prognostic utility in understanding the variability in stroke recovery.

Eligibility

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.

Study details
    Ischemic Stroke
    Obstructive Sleep Apnea

NCT04130503

Yale University

26 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.