A Study to Evaluate Effects on Sleep and Safety of RE03 in PTSD Patients With Sleep Disturbances
- Conditions
- Posttraumatic Stress Disorder (PTSD)Sleep Disturbances and Insomnia
- Interventions
- Drug: Placebo
- Registration Number
- NCT06685965
- Lead Sponsor
- Reconnect Labs
- Brief 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.
- Detailed Description
Participants spend one screening night followed by three treatment nights in the sleep lab, where they receive either a low dose, a high dose of dexmedetomidine, or a placebo. All participants receive all three options, with only the sequence differing. Participants and the study team are blinded and thus do not know which dose (or placebo) has been assigned.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Low dose RE03 low dose of RE03 High dose RE03 High dose of RE03 Placebo control Placebo Matching Placebo
- Primary Outcome Measures
Name Time Method Time spent in sleep stages N2 + N3 0.5 hours after each substance administration for 9 hours or until terminal morning awakening The total duration (in minutes) of sleep stages N2+N3, as measured by polysomnography (PSG) on the night following administration of each treatment \[minutes spent in N2 + N3\].
- Secondary Outcome Measures
Name Time Method REM fragmentation index 0.5 hours after each substance administration for 9 hours or until terminal morning awakening The rapid eye movement (REM) fragmentation index as measured by polysomnography (PSG) on the night following administration of each treatment \[# of entries from REM sleep into stage N1 or wake divided by total sleep time\].
Trial Locations
- Locations (1)
Human Sleep Pharmacology, University of Zurich
🇨🇭Zürich, ZH, Switzerland
Human Sleep Pharmacology, University of Zurich🇨🇭Zürich, ZH, Switzerland