Could a sleep drug reset the aging Brain's daily rhythms?

NCT ID NCT07800910

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Recruiting now
This trial is taking on new participants right now.
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Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
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First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

Researchers at Massachusetts General Hospital are testing whether a single under-the-tongue dose of dexmedetomidine, a sedative, can safely alter sleep patterns, internal 24-hour rhythms, and daily cycles of a brain-aging protein in adults aged 65 and older. In this double-blind, placebo-controlled crossover pilot study, 12 participants will receive both the drug and a placebo across two 3-night lab stays, with follow-up monitoring at home. The study focuses on safety and feasibility, measuring heart rate, blood pressure, sleep architecture, and blood biomarkers like p-tau217.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A single 120 microgram dose of dexmedetomidine given as a sublingual (under-the-tongue) film
What this could lead to
If it works, this could point toward a way to improve sleep and circadian rhythms in older adults, potentially slowing brain aging.
What could go wrong
This is a very early, small pilot study with only 12 participants, so results may not apply broadly. The drug can cause low blood pressure, slow heart rate, and excessive sedation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 12 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 65 years or older * Able to provide informed consent * Willing and able to comply with all study procedures, including in-laboratory and ambulatory monitoring * Able to provide informed consent using an IRB-approved translated consent document (when available) and complete study procedures with translated materials and/or qualified interpreter services, if needed- Stable residence and sleep schedule sufficient to complete study monitoring periods * Able to safely discontinue or adjust medications that may interfere with study procedures or outcomes, as determined by the study investigator Exclusion Criteria: * Clinically significant sleep disorders including narcolepsy, severe obstructive sleep apnea, REM sleep behavior disorder, or periodic limb movement disorder * Clinically significant cardiovascular disease including bradyarrhythmia, conduction abnormalities, heart failure, cardiomyopathy, ischemic heart disease, or conditions increasing risk with dexmedetomidine * Known QT prolongation, clinically significant arrhythmias, symptomatic bradycardia, hypokalemia, hypomagnesemia, or concurrent use of QT-prolonging medications * Contraindication or allergy to dexmedetomidine or study medications * Severe hepatic impairment * Neurologic, psychiatric, or substance use disorders that may interfere with participation or data interpretation * Use of medications significantly affecting sleep, circadian rhythms, or cardiovascular function * Gastrointestinal conditions increasing risk of capsule retention or bowel obstruction * Swallowing disorders or aspiration risk * Presence of implantable electronic medical devices * Use of anticoagulant or antiplatelet medications increasing bleeding risk * Pregnancy or breastfeeding * Shift work or frequent travel across more than two time zones * Participation in another interventional study that may interfere with study participation or interpretation of results * Anticipated need for MRI during the period in which the ingestible telemetry capsule may remain in the body * Inability to tolerate study procedures (blood draws, PSG, wearable devices, ingestible capsule) * Unable to provide informed consent even with translated materials/interpreter support * Previous participation in this trial * Concurrent interventional studies that may interfere with participation

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02129, United States

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