AdultsPhase 1/2NCT07704385
Enhancing Rehabilitation in Aging Study (ERAS)
A Phase 1/2 study testing Istradefylline 20 mg and Acute Intermittent Hypoxia (AIH) in people with Adults, run by University of Florida.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Adults
- What is being tested?
- Istradefylline 20 mg and Acute Intermittent Hypoxia (AIH)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 31 Dec 2031
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 40-79 years Non-smokers Ambulatory in the community Do not require assistance to complete activities of daily living
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- Istradefylline 20 mg, Placebo, Acute Intermittent Hypoxia (AIH)
- Keywords
- Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Istradefylline 20 mgDrug
Participants will receive 20 mg istradefylline active treatment, followed by acute intermittent hypoxia
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| AIH + placebo | Placebo comparator | Participants will receive a methylcellulose capsule identical in appearance to the experimental treatment, followed by acute intermittent hypoxia Receives: Drug: Placebo; Other: Acute Intermittent Hypoxia (AIH) |
| AIH + Istradefylline | Experimental | Participants will receive 20 mg, followed by acute intermittent hypoxia Receives: Drug: Istradefylline 20 mg; Other: Acute Intermittent Hypoxia (AIH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Inspiratory Pressure
Most negative pressure generated during a maximal inspiratory effort.
Measured: 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.
Measured: From enrollment to a 3-week follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 May 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdultsStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07704385
- Sponsor's protocol ID
- IRB202500524
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Rehabilitation in Aging Study (ERAS)
- ClinicalTrials.gov ID
- NCT07704385
- Acronym / sponsor ID
- IRB202500524
- Conditions
- Adults
- Keywords
- Adults
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 May 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AIH + placebo | Placebo comparator | Drug: Placebo, Other: Acute Intermittent Hypoxia (AIH)Participants will receive a methylcellulose capsule identical in appearance to the experimental treatment, followed by acute intermittent hypoxia |
| AIH + Istradefylline | Experimental | Drug: Istradefylline 20 mg, Other: Acute Intermittent Hypoxia (AIH)Participants will receive 20 mg, followed by acute intermittent hypoxia |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Aged 40-79 years Non-smokers Ambulatory in the community Do not require assistance to complete activities of daily living
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Istradefylline 20 mgParticipants will receive 20 mg istradefylline active treatment, followed by acute intermittent hypoxia | Drug | AIH + Istradefylline |
| PlaceboParticipants will receive a methylcellulose capsule identical in appearance to the active treatment, followed by acute intermittent hypoxia | Drug | AIH + placebo |
| Acute Intermittent Hypoxia (AIH)Short periods (~1 minute) of breathing lower-oxygen gas, separated by periods (~1 minute) of breathing normal oxygen air. | Other | AIH + Istradefylline, AIH + placebo |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Istradefylline 20 mg and Acute Intermittent Hypoxia (AIH) in people with Adults, run by University of Florida.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ushna Khan, MD (352-273-6855, ushnakhan@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Inspiratory Pressure (time frame: From enrollment to a 3-week follow-up.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.