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Not yet recruiting NCT07704385

Enhancing Rehabilitation in Aging Study (ERAS)

Phase I / Phase II Interventional Adults

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Istradefylline 20 mg, Placebo, Acute Intermittent Hypoxia (AIH).
Who it may be relevant to
Registry conditions: Adults. Basic parameters: 40 years — 79 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug Istradefylline 20 mg
    Participants will receive 20 mg istradefylline active treatment, followed by acute intermittent hypoxia
  • Drug Placebo
    Participants will receive a methylcellulose capsule identical in appearance to the active treatment, followed by acute intermittent hypoxia
  • Other Acute Intermittent Hypoxia (AIH)
    Short periods (\~1 minute) of breathing lower-oxygen gas, separated by periods (\~1 minute) of breathing normal oxygen air.

Primary outcome measures

  • Maximal Inspiratory Pressure [Time frame: From enrollment to a 3-week follow-up.]
  • Maximal grip force [Time frame: From enrollment to a 3-week follow up.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07704385 · IRB202500524

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗