Decreasing Nightmares in Adults with Narcolepsy

Not Applicable

Not yet recruiting

• Conditions: Narcolepsy; Narcolepsy Type 1; Narcolepsy with Cataplexy; Narcolepsy Without Cataplexy; Nightmare; Nightmare Disorder with Associated Other Sleep Disorder
• Interventions: Behavioral: Imagery Rehearsal Therapy (IRT)

• Registration Number: NCT06383806
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-22
• Study First Submitted QC: 2024-04-22
• Study First Posted: 2024-04-25
• Status Verified: 2024-10
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13
• Study Start: 2025-03
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Waitlist	Imagery Rehearsal Therapy (IRT)	The Waitlist arm will undergo a waiting period following the first assessment and then will receive the treatment after the second assessment.
Treatment	Imagery Rehearsal Therapy (IRT)	The Treatment arm will receive the intervention immediately following the first assessment.

Primary Outcome Measures

Name	Time	Method
Disturbing Dream and Nightmare Severity Index (DDNSI)	Completed at each of the three assessments (baseline, 10 weeks, 19 weeks)	The DDNSI is a questionnaire which measures the severity of nightmares.
Nightmare frequency (sleep diary)	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.

Secondary Outcome Measures

Name	Time	Method
PROMIS Anxiety	Completed at each of the three assessments (baseline, 10 weeks, 19 weeks)	Questionnaire which measures the severity of anxiety symptoms.
PROMIS Depression	Completed at each of the three assessments (baseline, 10 weeks, 19 weeks)	Questionnaire which measures the severity of depressive symptoms.