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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
First received
Last updated
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
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 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

Study Design


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)
See also
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