A Phase-2, Double-Blind, Randomized, Placebo-controlled, Crossover Dose-Finding, Laboratory-based Study to Evaluate Effects on Sleep and Safety of RE03 in PTSD Patients With Sleep Disturbances
Overview
- Phase
- Phase 2
- Intervention
- RE03
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Sponsor
- Reconnect Labs
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Time spent in sleep stages N2 + N3
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Low dose
low dose of RE03
Intervention: RE03
High dose
High dose of RE03
Intervention: RE03
Placebo control
Matching Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Time spent in sleep stages N2 + N3
Time Frame: 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 Outcomes
- REM fragmentation index(0.5 hours after each substance administration for 9 hours or until terminal morning awakening)