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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06441864
Other study ID # STU00220863
Secondary ID 09-SRG-23
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2024
Est. completion date March 1, 2025

Study information

Verified date June 2024
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 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.


Recruitment information / eligibility

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

Study Design


Intervention

Behavioral:
Cognitive Behavioral Therapy for Nightmares
The intervention will consist of 7 therapy sessions (once per week for 7 weeks) which will be delivered via videoconference. Partners will attend 2 of the 7 treatment sessions. During the sessions, participants will learn techniques for managing and changing nightmares.

Locations

Country Name City State
United States Northwestern University Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

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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