- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06383806
Decreasing Nightmares in Adults With Narcolepsy (DAWN)
July 14, 2026 updated by: Jennifer Mundt, University of Utah
Imagery Rehearsal Therapy for the Treatment of Nightmares in Narcolepsy: A Pilot Randomized Controlled Trial
The purpose of this clinical trial is learn whether a behavioral (non-medication) treatment can reduce nightmares in adults with narcolepsy.
All participants will receive the treatment and will complete three assessments.
Half of the participants will receive the treatment after the first assessment, and half will receive it after the second assessment.
Romantic partners of participants with narcolepsy will also be eligible to enroll in the study.
Partners will complete three assessments but will not participate in the treatment.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jennifer Mundt, PhD
- Phone Number: 801-646-8287
- Email: DAWNstudy@utah.edu
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84108
- Recruiting
- University of Utah
-
Contact:
- Jennifer Mundt, PhD
- Phone Number: 801-646-8287
- Email: DAWNstudy@utah.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
PARTICIPANTS WITH NARCOLEPSY/NIGHTMARES
Inclusion Criteria:
- Diagnosis of narcolepsy type 1 or narcolepsy type 2
- Nightmare frequency of ≥1 times per week
- Age 18 or older
- Able to speak, read, and write in English
- Live in the United States
- Sleep and psychiatric medications stable for ≥ 1 month and willing to keep medications stable for the duration of the study
Exclusion Criteria:
- Currently engaged in trauma- or sleep-related psychotherapy
- Previous behavioral treatment for nightmares
- Medical, psychiatric, or cognitive condition which would interfere with ability to engage in the treatment
- Untreated moderate-severe sleep apnea
PARTICIPANTS WHO ARE PARTNERS OF SOMEONE WITH NARCOLEPSY
Inclusion Criteria:
- Live with a romantic partner who meets the above criteria and has agreed to participate in the study
- Age 18 or older
- Able to speak, read, and write in English
- Live in the United States
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment
The Treatment arm will receive the intervention immediately following the first assessment.
|
The intervention will consist of 7 therapy sessions (once per week for 7 weeks) which will be delivered via videoconference.
During the sessions, participants will learn techniques for managing and changing nightmares.
Other Names:
|
|
Other: Waitlist
The Waitlist arm will undergo a waiting period following the first assessment and then will receive the treatment after the second assessment.
|
The intervention will consist of 7 therapy sessions (once per week for 7 weeks) which will be delivered via videoconference.
During the sessions, participants will learn techniques for managing and changing nightmares.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Disturbing Dream and Nightmare Severity Index (DDNSI)
Time Frame: Completed at each of the three assessments (baseline, 10 weeks, 19 weeks)
|
The DDNSI is a questionnaire which measures the severity of nightmares.
|
Completed at each of the three assessments (baseline, 10 weeks, 19 weeks)
|
|
Nightmare frequency (sleep diary)
Time Frame: Completed at each of the three assessments (baseline, 10 weeks, 19 weeks)
|
The number of nightmares experienced each day will be collected on daily sleep diaries completed during each assessment period.
|
Completed at each of the three assessments (baseline, 10 weeks, 19 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PROMIS Anxiety
Time Frame: Completed at each of the three assessments (baseline, 10 weeks, 19 weeks)
|
Questionnaire which measures the severity of anxiety symptoms.
|
Completed at each of the three assessments (baseline, 10 weeks, 19 weeks)
|
|
PROMIS Depression
Time Frame: Completed at each of the three assessments (baseline, 10 weeks, 19 weeks)
|
Questionnaire which measures the severity of depressive symptoms.
|
Completed at each of the three assessments (baseline, 10 weeks, 19 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Pisko J, Pastorek L, Buskova J, Sonka K, Nevsimalova S. Nightmares in narcolepsy: underinvestigated symptom? Sleep Med. 2014 Aug;15(8):967-72. doi: 10.1016/j.sleep.2014.03.006. Epub 2014 Apr 13.
- Schredl M. Editorial for "Nightmares in narcolepsy--under-investigated symptom?" (SLEEP-D-13-00591) Understanding and treating nightmares in patients with narcolepsy. Sleep Med. 2014 Aug;15(8):851-2. doi: 10.1016/j.sleep.2014.05.003. Epub 2014 May 16. No abstract available.
- Leu-Semenescu S, Maranci JB, Lopez R, Drouot X, Dodet P, Gales A, Groos E, Barateau L, Franco P, Lecendreux M, Dauvilliers Y, Arnulf I. Comorbid parasomnias in narcolepsy and idiopathic hypersomnia: more REM than NREM parasomnias. J Clin Sleep Med. 2022 May 1;18(5):1355-1364. doi: 10.5664/jcsm.9862.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2026
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 1, 2027
Study Registration Dates
First Submitted
April 22, 2024
First Submitted That Met QC Criteria
April 22, 2024
First Posted (Actual)
April 25, 2024
Study Record Updates
Last Update Posted (Actual)
July 15, 2026
Last Update Submitted That Met QC Criteria
July 14, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB_00188162
- 372-SR-25 (Other Grant/Funding Number: American Academy of Sleep Medicine Foundation)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.