Could a sleep machine boost stroke recovery?

NCT ID NCT04130503

Disease control Sponsor: Yale University Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study looks at whether using a positive airway pressure (PAP) machine to treat obstructive sleep apnea can help people recover better after an ischemic stroke. About 360 participants who have had a stroke and have moderate to severe sleep apnea will be randomly assigned to receive PAP treatment or usual care. The main goal is to see if PAP improves functional recovery and daily living skills.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Positive airway pressure (PAP) device
What this could lead to: If it works, this could show that treating sleep apnea after a stroke helps people recover better and regain more independence.
What could go wrong: This is a relatively early-stage study with 360 participants, so results may not apply to everyone. The treatment may not improve recovery beyond standard care, and some people may find PAP uncomfortable to use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 360 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2019

Expected to finish

Oct 2025

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

ischemic stroke obstructive sleep apnea syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ischemic stroke Obstructive sleep apnea

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

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Could a sleep machine boost stroke recovery?

What the study statuses mean