A Study to Evaluate Effects on Sleep and Safety of RE03 in PTSD Patients With Sleep Disturbances
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-64
SponsorReconnect Labs
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 involving the administration of an investigational or marketed drug or device within 30 days prior to the first dose; administration of a biological product (e.g. vaccines, blood components, gene therapies, tissues, etc.) in the context of a clinical research study within 90 days prior to the first dose; or concomitant participation in an investigational study involving drug or device administration
Post-menopausal (status defined as an absence of menses for at least 12 months prior to the first study drug administration); or
Trial design
Design model
Crossover
Treatments tested in this trial
RE03
DrugBuccal Dexmedetomidine
Placebo
DrugMatching Placebo
Treatment groups
24 Participants
are divided into 3 treatment groupsGroup A: Low doseExperimental treatment 1 intervention
Group B: High doseExperimental treatment 1 intervention
Group C: Placebo controlPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Time spent in sleep stages N2 + N3
The total duration (in minutes) of sleep stages N2+N3, as measured by polysomnography (PSG) on the night following administration of each treatment \[minutes spent in N2 + N3\].
Time frame
0.5 hours after each substance administration for 9 hours or until terminal morning awakeningSecondary outcomes
1
REM fragmentation index
The rapid eye movement (REM) fragmentation index as measured by polysomnography (PSG) on the night following administration of each treatment \[# of entries from REM sleep into stage N1 or wake divided by total sleep time\].
Time frame
0.5 hours after each substance administration for 9 hours or until terminal morning awakeningSponsors and contacts
Click on the lead sponsor to view all of their trials.
Reconnect Labs
Lead sponsor
University of Zurich
Collaborator
Source ClinicalTrials.gov