CompletedPhase 2

A Study to Evaluate Effects on Sleep and Safety of RE03 in PTSD Patients With Sleep Disturbances

Switzerland12 participantsStarted 2025-09-30

Plain-language summary

Post-traumatic stress disorder (PTSD) affects many people who have experienced traumatic events. A common issue with PTSD is severe sleep disturbances, such as nightmares. Current treatments often do not provide sufficient relief, especially for sleep problems. This study aims to determine whether dexmedetomidine - a medication already used in intensive care - can improve sleep quality in PTSD patients.

Who can participate

Age range

18 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Participants fulfilling all of the following inclusion criteria are eligible for the study: * Male or female, aged ≥18 and ≤64 years (inclusive) * Diagnosis of PTSD according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) for more than 6 months * PTSD diagnosis assessed with CAPS-5 (life-time) severity ≥ 2 * Sleep disturbance, e.g., difficulty falling or staying asleep, or restless sleep (Criterion E6 of the DSM-5 criteria for PTSD) is present for at least a month prior to screening and causes clinically significant distress or impairment in social, occupational, or other important areas of functioning * Sleep disturbance assessed with the PSQI; severity ≥ 5 * Ability (verified by investigator) and willingness to provide informed consent as documented by dated signature The presence of any one of the following exclusion criteria will lead to exclusion of the participant: * Inability to comply with sleep-wake schedule related study requirements, e.g. due to crossing of time zones (≥ 2), extreme chronotypes, shift working within 2 weeks prior to the screening visit, or planned shift work during the study, self-reported usual daytime napping ≥1 hour per day, and ≥3 days per week * Inability to follow the procedures of the study, e.g. due to insufficient understanding of the German language used in the study as evaluated by the investigator or anticipated problems with overnight stays at the sleep laboratory * Participation in a clinical research study in…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time spent in sleep stages N2 + N3

Timeframe: 0.5 hours after each substance administration for 9 hours or until terminal morning awakening

Trial details

NCT IDNCT06685965

SponsorReconnect Labs

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06-14

View on ClinicalTrials.gov More Posttraumatic Stress Disorder (PTSD) trials