Clinical trial NCT06383806: Decreasing Nightmares in Adults with Narcolepsy
Official title: Imagery Rehearsal Therapy for the Treatment of Nightmares in Narcolepsy: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Narcolepsy
Narcolepsy Type 1
Narcolepsy with Cataplexy
Narcolepsy Without Cataplexy
Nightmare
Nightmare Disorder with Associated Other Sleep Disorder
Keywords: Imagery Rehearsal Therapy
Cognitive Behavioral Therapy for Nightmares
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Waitlist control
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Disturbing Dream and Nightmare Severity Index (DDNSI)
timeFrame: Completed at each of the three assessments (baseline, 10 weeks, 19 weeks)
measure: Nightmare frequency (sleep diary)
timeFrame: Completed at each of the three assessments (baseline, 10 weeks, 19 weeks)
Secondary outcomes:
measure: PROMIS Anxiety
timeFrame: Completed at each of the three assessments (baseline, 10 weeks, 19 weeks)
measure: PROMIS Depression
timeFrame: Completed at each of the three assessments (baseline, 10 weeks, 19 weeks)
Other outcomes:
Locations:
Study officials:
References:
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.
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.
citation: 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.