Assessing Upper Extremity Function in Chronic Stroke Survivors Through Acute Intermittent Hypoxia

NCT ID: NCT07113457

Last Updated: 2025-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2027-08-31

Brief Summary

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Here we aim to observe effects of acute intermittent hypoxia in persons who have experienced a single stroke. We have previously shown this technique to be safe and effective at increasing strength in persons with disabilities, and here are aiming to determine the mechanism of how the breathing method modulates motor function.

Detailed Description

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Here we aim to observe effects of acute intermittent hypoxia in persons who have experienced a single stroke. We have previously shown this technique to be safe and effective at increasing strength in persons with disabilities, and here are aiming to determine the mechanism of how the breathing method modulates motor function.

Conditions

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Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Hypoxia

Participants in this arm will receive approximately 15 bouts of acute intermittent hypoxia. This intervention involves breathing lowered levels of oxygen (similar to being on a tall mountain) for 60 seconds at a time, followed by 60 seconds of room air. Participants will be assessed following the intervention.

Group Type EXPERIMENTAL

Acute Intermittent Hypoxia (AIH)

Intervention Type OTHER

This intervention involves breathing lowered levels of oxygen (similar to those experienced on a tall mountain) for 60 seconds at a time. This is immediately followed by 60 seconds of breathing normal room air. These bouts are repeated approximately 15 times. For the intervention, the participant is fitted with a non-rebreathing mask which supplies the two different air levels

Interventions

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Acute Intermittent Hypoxia (AIH)

This intervention involves breathing lowered levels of oxygen (similar to those experienced on a tall mountain) for 60 seconds at a time. This is immediately followed by 60 seconds of breathing normal room air. These bouts are repeated approximately 15 times. For the intervention, the participant is fitted with a non-rebreathing mask which supplies the two different air levels

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* A first time, unilateral, ischemic, hemispheric stroke, confirmed by MRI
* Chedoke stage of hand assessment \>= 3
* Ability to open and close affected hand
* Able to understand and communicate in english
* Able to independently consent
* over 6 months post stroke
* Must have a hemoglobin level above 10g/dl
* Must have ability to leave research visit with a compainon/group trasportation
* WOCBP must be comfortable confirming negative pregnancy prior to hypoxia
* Must not be involved in any other research intervention study testing upper extremities

Exclusion Criteria

* History of prior neurological disorders
* Brain stem or cerebellar stroke; mean Fazekas score rated on initial fluid-attenuated inversion recovery MRI greater than equal to 3
* Severe Aphasisa
* Pre-existing hypoxic pulmonary disease
* Includes positive Covid-pneumonia diagnosis within 1 year of screening visit
* Severe hypertension (\>160/100)
* Any ischemic cardiac disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

Shirley Ryan AbilityLab

OTHER

Sponsor Role lead

Responsible Party

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Zev Rymer

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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William Z Rymer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Shirley Ryan AbilityLab

Central Contacts

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William Z Rymer, MD, PhD

Role: CONTACT

312-238-3919

Alexander J Barry, MS, CCRC

Role: CONTACT

312-238-1435

Other Identifiers

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R21NS130367-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STU00223882

Identifier Type: -

Identifier Source: org_study_id

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