Enhancing Rehabilitation in Aging Study (ERAS)

NCT07704385 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: IRB202500524
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Adults

Keywords

Adults

Outcome Measures

Primary Outcomes (2)

• Maximal Inspiratory Pressure

  Most negative pressure generated during a maximal inspiratory effort.

  From enrollment to a 3-week follow-up.

• Maximal grip force

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

  From enrollment to a 3-week follow up.

Study Arms (2)

AIH + placebo

PLACEBO COMPARATOR

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

Drug: Placebo; Other: Acute Intermittent Hypoxia (AIH)

AIH + Istradefylline

EXPERIMENTAL

Participants will receive 20 mg, followed by acute intermittent hypoxia

Drug: Istradefylline 20 mg; Other: Acute Intermittent Hypoxia (AIH)

Interventions

Istradefylline 20 mg DRUG

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

AIH + Istradefylline

Placebo DRUG

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

AIH + placebo

Acute Intermittent Hypoxia (AIH) OTHER

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

AIH + Istradefylline; AIH + placebo

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

MeSH Terms

Interventions

istradefylline

Central Study Contacts

Ushna Khan, MD

CONTACT

352-273-6855; ushnakhan@ufl.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 15, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): May 31, 2031
• Study Completion (Estimated): December 31, 2031
• Last Updated: July 15, 2026

Record last verified: 2026-07