REM Sleep Behavior Disorder Clinical Trial
Official title:
Behavioral Treatment for Nightmares in REM Sleep Behavior Disorder
Verified date | June 2024 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 romantic partners. All participants will receive the treatment via videoconference and will complete 2 assessments. Participants with RBD will attend 7 sessions, and their partners will attend 2 of those sessions with them.
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | March 1, 2025 |
Est. primary completion date | March 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 romantic partner 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 (Partners): - Live with a romantic partner who meets all of the above criteria - Age 18 or older - Speak, read, and write English - Live in the United States |
Country | Name | City | State |
---|---|---|---|
United States | Northwestern University | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Northwestern University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disturbing Dream and Nightmare Severity Index (DDNSI) | The DDNSI is a questionnaire which measures the severity of nightmares. | Through study completion (11-13 weeks) | |
Primary | Nightmare frequency (sleep diary) | The number of nightmares experienced each day will be collected on daily sleep diaries completed during each assessment period. | Through study completion (11-13 weeks) |
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