Actively Recruiting

Phase 2
Age: 18Years - 64Years
All Genders
NCT06685965

A 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

46 weeks

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) 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 64Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 18 to 64 years inclusive
  • Diagnosis of PTSD according to DSM-5 for more than 6 months
  • PTSD severity score of 2 or higher assessed with CAPS-5 (life-time)
  • Presence of sleep disturbance (difficulty falling or staying asleep, or restless sleep) for at least 1 month causing significant distress or impairment
  • Sleep disturbance severity score of 5 or higher assessed with PSQI
  • Ability and willingness to provide informed consent
Not Eligible

You will not qualify if you...

  • Inability to comply with sleep-wake schedule requirements due to time zone crossing, extreme chronotypes, shift work within 2 weeks prior, or frequent daytime napping
  • Insufficient understanding of German or problems with overnight sleep lab stays
  • Participation in other drug or device clinical research within 30 days prior or biological product studies within 90 days prior
  • Females of childbearing potential not using required contraceptive methods during and for 3 months after the study
  • Females not post-menopausal or surgically sterilized
  • Males not vasectomised with female partners of childbearing potential not using contraception
  • Males with pregnant partners not willing to use condoms during and 3 months after the study
  • Males unwilling to abstain from sperm donation for 3 months after last dose
  • Body mass index below 17.5 or above 35 kg/m2
  • History of significant cardiovascular disorders including arrhythmias, bradycardia, tachycardia, hypotension, hypertension grade 2 or higher, QT prolongation, myocardial infarction, or cerebrovascular disease
  • Peripheral arterial occlusive disease
  • Epilepsy, seizures, severe head trauma, or stroke history
  • Chronic obstructive pulmonary disease, pulmonary fibrosis, or respiratory diseases risking depression under RE03 treatment
  • Unstable or significant medical illness or acute injury
  • Clinically significant abnormal liver function or thyroid dysfunction
  • Suicidality with severity 4 or higher or suicide attempt within last 12 months
  • Sleep disorders such as restless leg syndrome, obstructive sleep apnea, narcolepsy, delayed-sleep phase syndrome, REM sleep behavior disorder, or NREM sleep arousal disorder
  • Bipolar disorder, psychotic disorders including schizophrenia, or recent substance-induced psychoses
  • Ongoing obsessive-compulsive disorder or anorexia nervosa
  • Moderate or severe alcohol use disorder within last 12 months
  • Severe substance use disorder for nicotine or cannabis and mild for other substances
  • Use of sedative medications that cannot be stopped before study
  • Use of beta-blockers or unstable antihypertensive medications
  • Recent changes in antidepressant treatment
  • Use of drugs that prolong QT interval without careful monitoring
  • Current psychological therapy with varying sessions or therapists started within 30 days prior or during study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Human Sleep Pharmacology, University of Zurich

Zurich, Canton of Zurich, Switzerland, 8057

Actively Recruiting

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Research Team

R

Robin von Rotz, MSc

CONTACT

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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