Narcolepsy Nightmare Study
Behavioral Treatment of Narcolepsy-Related Nightmares
1 other identifier
interventional
7
1 country
1
Brief Summary
The goal of this clinical trial is to test two behavioral treatments for nightmares in adults with narcolepsy. The main questions it aims to answer are:
- Is imagery rehearsal therapy (IRT) effective for narcolepsy-related nightmares?
- Does adding targeted dream control (TDC) to IRT make it more effective? Participants will be randomized to one of two treatment groups and will be asked to:
- Complete a daily log of sleep symptoms for up to 13 weeks.
- Attend 7 sessions of treatment.
- Complete questionnaires before and after treatment.
- Go to the research lab in Evanston, IL to complete a sleep study during a daytime nap (Chicago area residents only).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2023
CompletedFirst Posted
Study publicly available on registry
February 2, 2023
CompletedStudy Start
First participant enrolled
February 22, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2024
CompletedJune 12, 2024
June 1, 2024
1.2 years
January 24, 2023
June 10, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Daily diary
Nightmare severity/frequency
Duration of study (11-13 weeks)
Study Arms (2)
Imagery rehearsal therapy (IRT)
EXPERIMENTALParticipants randomized to this group will receive 7 sessions of IRT.
Imagery rehearsal therapy and targeted dream control (IRT+TDC)
EXPERIMENTALParticipants randomized to this group will receive 7 sessions of IRT+TDC.
Interventions
Therapy to reduce nightmares, delivered via videoconference sessions
Therapy to reduce nightmares, delivered in videoconference sessions and lab session. Lab session will involve a sleep study during a daytime nap.
Eligibility Criteria
You may qualify if:
- Diagnosis of narcolepsy
- Age 18 or older
- Speak English
- Live in the United States
- Receiving standard medical care for narcolepsy
- Sleep and psychiatric medications stable for at least 3 months
- Nightmare frequency of ≥3 times per week
- Nightmare Disorder Index score indicates probable nightmare disorder
- Able to attend a study appointment in Evanston, IL
- Able and willing to not take wake-promoting medications on day of lab visit
You may not qualify if:
- History of a neurological disorder that might alter EEG
- Currently engaged in sleep- or trauma-focused psychotherapy
- Previous behavioral treatment for nightmares
- Medical, psychiatric, or cognitive condition which would interfere with ability to engage in the treatment
- Untreated sleep apnea (AHI ≥ 5)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northwestern University
Chicago, Illinois, 60611, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Mundt, PhD
Northwestern University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2023
First Posted
February 2, 2023
Study Start
February 22, 2023
Primary Completion
April 30, 2024
Study Completion
April 30, 2024
Last Updated
June 12, 2024
Record last verified: 2024-06