Participate in our trial
PTSD is a mental disorder that can occur after traumatic experiences like violence, sexual abuse, accidents, war, or natural disasters. People affected often feel overly alert, re-experience traumatic memories (called flashbacks), and may feel emotionally numb and helpless. Many also have sleep problems, such as nightmares and poor sleep quality. These issues lead to significant difficulties in daily life and reduce quality of life. Current treatments like cognitive behavioral therapy and antidepressants often don’t provide satisfactory results. There’s a lack of targeted treatments for sleep disturbances in PTSD, highlighting the need for new therapies.
In this study, we’re investigating the use of a test substance called RE03 (Dexmedetomidine) to improve sleep quality, reduce nightmares, and enhance daytime symptoms. We’ll also examine how well the test substance is tolerated.
The study has three parts: tab1
- First Part: We’ll assess whether you’re suitable to participate by checking your general health. Using a sleep study called polysomnography, we’ll also see if you have any undetected sleep disorders (like sleep apnea).
- Second Part: Over three nights, you’ll receive the test substance in doses of 64 µg and 96 µg, and a placebo (no active ingredient, 0 µg), in random order. This helps us determine if these doses can improve your sleep.
- Third Part: You’ll take the test substance in doses of 64 µg or 96 µg home for 19 days, taking it each evening before bed. Before you can take it home, we’ll check over two consecutive nights in the sleep lab to ensure you tolerate it well and that home use is safe.
Each appointment in the sleep lab lasts about 14 hours (approximately 4 hours before sleep, 8 hours of sleep, and 2 hours after waking up). The study visits are spread over about 5-7 weeks, and we can flexibly adjust the appointments to fit your availability
The study has three parts: tab2
- First Part: We’ll assess whether you’re suitable to participate by checking your general health. Using a sleep study called polysomnography, we’ll also see if you have any undetected sleep disorders (like sleep apnea).
- Second Part: Over three nights, you’ll receive the test substance in doses of 64 µg and 96 µg, and a placebo (no active ingredient, 0 µg), in random order. This helps us determine if these doses can improve your sleep.
- Third Part: You’ll take the test substance in doses of 64 µg or 96 µg home for 19 days, taking it each evening before bed. Before you can take it home, we’ll check over two consecutive nights in the sleep lab to ensure you tolerate it well and that home use is safe.
Each appointment in the sleep lab lasts about 14 hours (approximately 4 hours before sleep, 8 hours of sleep, and 2 hours after waking up). The study visits are spread over about 5-7 weeks, and we can flexibly adjust the appointments to fit your availability
The study has three parts: tab3
- First Part: We’ll assess whether you’re suitable to participate by checking your general health. Using a sleep study called polysomnography, we’ll also see if you have any undetected sleep disorders (like sleep apnea).
- Second Part: Over three nights, you’ll receive the test substance in doses of 64 µg and 96 µg, and a placebo (no active ingredient, 0 µg), in random order. This helps us determine if these doses can improve your sleep.
- Third Part: You’ll take the test substance in doses of 64 µg or 96 µg home for 19 days, taking it each evening before bed. Before you can take it home, we’ll check over two consecutive nights in the sleep lab to ensure you tolerate it well and that home use is safe.
Each appointment in the sleep lab lasts about 14 hours (approximately 4 hours before sleep, 8 hours of sleep, and 2 hours after waking up). The study visits are spread over about 5-7 weeks, and we can flexibly adjust the appointments to fit your availability