Decreasing Nightmares in Adults With Narcolepsy

Narcolepsy Clinical Trial

— DAWN  

Official title:

Imagery Rehearsal Therapy for the Treatment of Nightmares in Narcolepsy: A Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06383806
• Other study ID #: STU00219933
• Secondary ID: 315-SR-23
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: September 2026

Study information

• Verified date: April 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 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

Related Conditions & MeSH terms

• Cataplexy
• Narcolepsy
• Narcolepsy Type 1
• Narcolepsy With Cataplexy
• Narcolepsy Without Cataplexy
• Nightmare
• Sleep Wake Disorders

Intervention

Behavioral:
• Imagery Rehearsal Therapy (IRT)
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

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.	2 weeks, completed at each of the three assessments (baseline, 10 weeks, 19 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.	2 weeks, completed at each of the three assessments (baseline, 10 weeks, 19 weeks)
Secondary	PROMIS Anxiety	Questionnaire which measures the severity of anxiety symptoms.	1 week, completed at each of the three assessments (baseline, 10 weeks, 19 weeks)
Secondary	PROMIS Depression	Questionnaire which measures the severity of depressive symptoms.	1 week, completed at each of the three assessments (baseline, 10 weeks, 19 weeks)