What this study is
The DEXTER study is a cross-over, double-blind, placebo-controlled pilot research study led by Dr. Peng Li. The goal of this project is to evaluate the safety, feasibility, and biological effects of a single dose of sublingual (under-the-tongue) dexmedetomidine (SL Dex) in older adults. Specifically, researchers want to see how this medication affects sleep patterns, internal 24-hour circadian rhythms, and the daily cycles of certain neurological proteins (specifically plasma p-tau217) associated with brain aging.
What's being tested
- Dexmedetomidine sublingual film
Intervention · DRUG
Participants receive a single 120 mcg dose of sublingual dexmedetomidine (IGALMI®) administered approximately 15-20 minutes before the scheduled sleep opportunity during the in-laboratory protocol.
- Placebo Sublingual Film
Intervention · DRUG
Participants receive a matched placebo sublingual film identical in appearance, packaging, and administration method to the active dexmedetomidine formulation but containing no active medication.
Study details
- Official title
- Dexmedetomidine Trial for Effects on Rhythms, Sleep Architecture, and Biomarker Dynamics - A Pilot Study (DEXTER)
- Sponsor
- Massachusetts General Hospital
- Conditions
- Sleep · Circadian Rhythm
- Enrolling
- 12 people
- Starts
- 2026-09-01
- Est. completion
- 2028-08-31
- Design
- Triple-blind, randomized, crossover, Early Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 65 Years and overSex ALLHealthy volunteers AcceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openBrigham and Women's Hospital
Boston, Massachusetts, United States
- Peng Li, PhD · Contact617-643-9514pli9@mgh.harvard.edu
Massachusetts General Hospital
Boston, Massachusetts, United States
Study team
Sponsor
Massachusetts General Hospital
Study ID 2026P001362
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.