Behavioral Treatment for Nightmares in REM Sleep Behavior Disorder (NCT06441864) | Clinical Trial Compass
RecruitingNot Applicable
Behavioral Treatment for Nightmares in REM Sleep Behavior Disorder
United States20 participantsStarted 2024-07-15
Plain-language summary
The purpose of this clinical trial is learn whether a behavioral (non-medication) treatment can reduce nightmares in adults with Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD). People with RBD will be enrolled in the study along with their family members (a partner or other family member residing in the same home). All participants will receive the treatment via videoconference and will complete 2 assessments. Participants with RBD will attend 7 sessions, and their family members will attend 2 of those sessions with them.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of isolated RBD or RBD secondary to neurodegenerative disease
* Age 18 or older
* Speak, read, and write English
* Live in the United States
* Nightmare frequency ≥3 times per week
* Disturbing Dream and Nightmare Severity Index score indicative of nightmare disorder
* Sleep, neurological, and psychiatric medications stable for at least 1 month and willing to keep medications stable through the course of the study
* Live with a family member who is willing to participate in the study
Exclusion Criteria:
* Possible dementia
* Narcolepsy
* Posttraumatic stress disorder
* Previous behavioral treatment for nightmares
* Currently engaged in sleep- or trauma-focused psychotherapy
* Taking a medication that could cause RBD, if the medication was started prior to onset of RBD symptoms
Inclusion Criteria (Family Members):
* Live with a family member who meets all of the above criteria
* Age 18 or older
* Speak, read, and write English
* Live in the United States
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Disturbing Dream and Nightmare Severity Index (DDNSI)