Dexmedetomidine Trial for Effects on Rhythms, Sleep Architecture, and Biomarker Dynamics in Older Adults
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age65+
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Dexmedetomidine sublingual film
DrugParticipants 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
DrugParticipants receive a matched placebo sublingual film identical in appearance, packaging, and administration method to the active dexmedetomidine formulation but containing no active medication.
Treatment groups
12 Participants
are divided into 2 treatment groupsGroup A: Sublingual Dexmedetomidine FirstExperimental treatment 2 interventions
Group B: Placebo FirstPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Number of Participants With Adverse Events
Number of participants experiencing one or more adverse events during the study, including hypotension, bradycardia, and excessive sedation.
Time frame
From first study intervention through completion of the 10-day ambulatory follow-up following the second study period2
Proportion of Participants Completing the Study
Proportion of enrolled participants who complete both study periods, including the in-laboratory protocols and post-laboratory ambulatory follow-up.
Time frame
Through completion of the 10-day ambulatory follow-up following the second study period3
Proportion of Consented Participants Who Are Randomized
Proportion of participants who provide informed consent and are subsequently randomized to a study intervention sequence, calculated as the number of randomized participants divided by the total number of participants who provide informed consent.
Time frame
At randomization, prior to the first study intervention4
Proportion of Participants Completing the In-Laboratory Protocol
Proportion of enrolled participants who complete the 3-night in-laboratory protocol during both study periods.
Time frame
Through completion of the second 3-night in-laboratory study periodSecondary outcomes
1
Dim Light Melatonin Onset (DLMO) timing
Circadian phase assessed using dim light melatonin onset derived from serial plasma melatonin sampling during controlled dim-light conditions.
Time frame
During the 3-hour dim-light period preceding habitual bedtime on each in-laboratory study day2
Sleep Latency Measured by Polysomnography
Sleep latency, defined as the time from lights out to sleep onset, measured by overnight polysomnography.
Time frame
Each night (Nights 1, 2, and 3) of each 3-night in-laboratory study period3
Total Sleep Time Measured by Polysomnography
Total time spent asleep during the overnight sleep period, measured by polysomnography and reported in minutes.
Time frame
Each night (Nights 1, 2, and 3) of each 3-night in-laboratory study period4
Sleep Efficiency Measured by Polysomnography
Sleep efficiency measured by polysomnography, calculated as total sleep time divided by time in bed multiplied by 100 and reported as a percentage.
Time frame
Each night (Nights 1, 2, and 3) of each 3-night in-laboratory study periodOther outcomes
1
Plasma p-tau217 Concentrations Across the 24-Hour Sleep-Wake Cycle
Serial plasma phosphorylated tau 217 (p-tau217) concentrations measured from venous blood samples collected every 4 hours across the 24-hour sleep-wake cycle, with additional hourly sampling during the 3-hour dim-light period preceding habitual bedtime, to characterize temporal p-tau217 dynamics under sublingual dexmedetomidine and placebo conditions.
Time frame
Across the 24-hour sleep-wake cycle during each in-laboratory study period2
Sleep Onset Time Measured by Wrist Actigraphy
Sleep onset time derived from wrist-worn actigraphy during ambulatory monitoring.
Time frame
Days 1-7 of the pre-laboratory monitoring period and Days 1-10 of the post-laboratory ambulatory monitoring period during each study period3
Total Sleep Time Measured by Wrist Actigraphy
Total sleep time derived from wrist-worn actigraphy during ambulatory monitoring and reported in minutes.
Time frame
Days 1-7 of the pre-laboratory monitoring period and Days 1-10 of the post-laboratory ambulatory monitoring period during each study period4
Sleep Fragmentation Index Measured by Wrist Actigraphy
Sleep fragmentation index derived from wrist-worn actigraphy during ambulatory monitoring.
Time frame
Days 1-7 of the pre-laboratory monitoring period and Days 1-10 of the post-laboratory ambulatory monitoring period during each study periodSponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
Brigham and Women's Hospital
Collaborator
Source ClinicalTrials.gov
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