Actively Recruiting
A Phase-2, Double-Blind, Randomized, Placebo-Controlled, Crossover Dose-Finding Study to Evaluate Effects on Sleep and Safety of RE03 in PTSD Patients With Sleep Disturbances
Led by Reconnect Labs · Updated on 2025-09-16
24
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
R
Reconnect Labs
Lead Sponsor
U
University of Zurich
Collaborating Sponsor
AI-Summary
What this Trial Is About
Post-traumatic stress disorder (PTSD) often causes severe sleep problems like nightmares, which can be hard to treat effectively. This trial evaluates whether dexmedetomidine, a medication already used in intensive care, can help improve sleep quality in adults with PTSD who have sleep disturbances. The study is a phase 2, randomized, double-blind, placebo-controlled trial focusing on sleep effects and safety. Participants spend one screening night followed by three treatment nights in a sleep lab. Each participant receives a low dose, a high dose of dexmedetomidine (RE03), and a placebo in different sequences, though neither participants nor researchers know the sequence during the study. This crossover design allows comparison of different doses and placebo effects on sleep. During the study nights, researchers monitor time spent in deep sleep stages and REM sleep fragmentation. Participants undergo sleep lab assessments each night for about 9 hours after dosing until morning awakening. The study also includes safety monitoring and evaluation of sleep quality changes. Overall participation includes screening and three treatment nights in a controlled lab setting.
CONDITIONS
Brief Title
A Study to Evaluate Effects on Sleep and Safety of RE03 in PTSD Patients With Sleep Disturbances
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 64 years (inclusive)
- Diagnosis of PTSD for more than 6 months
- PTSD severity score of 2 or higher by CAPS-5
- Sleep disturbance present for at least one month prior to screening causing significant distress or impairment
- Sleep disturbance severity score of 5 or higher by PSQI
- Ability and willingness to provide informed consent
You will not qualify if you...
- Inability to comply with sleep-wake schedule requirements such as recent shift work or frequent daytime napping
- Insufficient understanding of German or anticipated problems with overnight sleep lab stays
- Participation in another drug or device clinical study within 30 to 90 days prior
- Females of childbearing potential not using acceptable contraception during and 3 months after study
- Females not post-menopausal or surgically sterilized
- Males not vasectomized or not using contraception with partners during and 3 months after study
- Body mass index below 17.5 or above 35 kg/m2
- History of clinically significant cardiovascular disorders or abnormal heart rates or blood pressure
- History of cerebrovascular disease or peripheral arterial occlusive disease
- History of epilepsy, seizures, severe head trauma, or stroke
- Chronic lung diseases causing respiratory depression risk
- Unstable medical conditions or significant acute illness
- Abnormal liver function or clinically significant lab abnormalities
- Suicidality or recent suicide attempt
- Sleep disorders like restless leg syndrome, sleep apnea, narcolepsy, REM sleep behavior disorder
- Bipolar disorder, psychotic disorders, obsessive-compulsive disorder, or anorexia nervosa
- Moderate or severe alcohol or substance use disorders
- Use of sedative medications that cannot be stopped
- Concurrent use of beta-blockers or unstable antihypertensive treatment
- Recent unstable antidepressant treatment
- Use of drugs that prolong QT interval without monitoring
- Current enrollment in or recent start of psychological therapy with varying frequency or therapists during study period
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 nights
Participants spend one screening night followed by three treatment nights in the sleep lab, receiving either a low dose, a high dose of dexmedetomidine, or a placebo in a random sequence. Participants and the study team are blinded to the treatment assignments.
1 screening night and 3 treatment nights (in-person)
Trial Site Locations
Total: 1 location
1
Human Sleep Pharmacology, University of Zurich
Zurich, Canton of Zurich, Switzerland, 8057
Actively Recruiting
Research Team
R
Robin von Rotz, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
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