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The Recovery in Stroke Using PAP Study

NCT04130503 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2025-09-05

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

PAP

Positive airway pressure (PAP) treatment of obstructive sleep apnea (OSA).

BEHAVIORAL

HLE

All patients (randomized and non-randomized) will receive a healthy lifestyle education (HLE) intervention focused on secondary stroke prevention.

Sponsors & Collaborators

  • Hartford HealthCare

    collaborator OTHER

  • National Institute of Nursing Research (NINR)

    collaborator NIH

  • American Academy of Sleep Medicine Foundation (AASM)

    collaborator UNKNOWN

  • Yale University

    lead OTHER

Principal Investigators

  • Klar Yaggi, MD, MPH · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2025-10-31
Completion
2025-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04130503 on ClinicalTrials.gov