RECRUITING

The Recovery in Stroke Using PAP Study

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Recovery in Stroke Using PAP Study

Quick Facts

Study Start:2019-09-01

Study Completion:2024-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04130503

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Radu Radulescu, MD

CONTACT

2033614037

radu.radulescu@yale.edu

Principal Investigator

Klar Yaggi, MD, MPH

PRINCIPAL_INVESTIGATOR

Yale University

Study Locations (Sites)

Yale University

New Haven, Connecticut, 06519

United States

Collaborators and Investigators

Sponsor: Yale University

Klar Yaggi, MD, MPH, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-09-01

Study Completion Date2024-12-31

Study Record Updates

Study Start Date2019-09-01

Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

Ischemic Stroke
Obstructive Sleep Apnea