Enhancing Rehabilitation in Aging Study (ERAS)

Acute Intermittent Hypoxia (AIH) is a rehab approach attributed to serotonin. AIH signaling also occurs via adenosine, and the pathways inhibit each other. Increased neural adenosine in aging may stymie AIH plasticity. The hypothesis is pre-treatment with adenosine 2A receptor inhibition (A2AI) enhances AIH effects on motor plasticity in unaffected adults. AIH exposures will be paired with A2AI or placebo, with a 4-week washout. Primary outcome measures include inspiratory and grip strength.

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Key information

Conditions

Adults

Age range

40 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Aged 40-79 years Non-smokers Ambulatory in the community Do not require assistance to complete activities of daily living

Exclusion criteria

Restrictive or obstructive lung conditions Pregnancy Active respiratory infections Use of antibiotics in the last 4 weeks Symptomatic cardiac disease BMI >35 kg/m2 Seizure disorder or progressive neurological condition Uses positive pressure mechanical ventilation when awake and upright, or oxygen assistance at any time

Treatment and study plan

Istradefylline 20 mg

Drug

Participants will receive 20 mg istradefylline active treatment, followed by acute intermittent hypoxia

Placebo

Drug

Participants will receive a methylcellulose capsule identical in appearance to the active treatment, followed by acute intermittent hypoxia

Acute Intermittent Hypoxia (AIH)

Other

Short periods (~1 minute) of breathing lower-oxygen gas, separated by periods (~1 minute) of breathing normal oxygen air.

Primary outcomes

Maximal Inspiratory Pressure

Time frame: From enrollment to a 3-week follow-up.

Most negative pressure generated during a maximal inspiratory effort.
Maximal grip force

Time frame: From enrollment to a 3-week follow up.

Highest tension generated by the flexor muscles of the hand during a maximal grip.

Study contacts

Contact information is provided by the study sponsor or research team.

Ushna Khan, MD

CONTACT

[email protected]

352-273-6855

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2031
Study completion: 2031
First posted: Jul 15, 2026
Registry last updated: Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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