Decreasing Nightmares in Adults With Narcolepsy

NCT06383806 | Not Yet Recruiting DMC

• 2 other identifiers: IRB_00188162372-SR-25
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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. 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.

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

Outcome Measures

Primary Outcomes (2)

• Disturbing Dream and Nightmare Severity Index (DDNSI)

  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)

  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 Outcomes (2)

• PROMIS Anxiety

  Completed at each of the three assessments (baseline, 10 weeks, 19 weeks)

• PROMIS Depression

  Completed at each of the three assessments (baseline, 10 weeks, 19 weeks)

Study Arms (2)

Treatment

EXPERIMENTAL

The Treatment arm will receive the intervention immediately following the first assessment.

Behavioral: Imagery Rehearsal Therapy (IRT)

Waitlist

OTHER

The Waitlist arm will undergo a waiting period following the first assessment and then will receive the treatment after the second assessment.

Behavioral: Imagery Rehearsal Therapy (IRT)

Interventions

Imagery Rehearsal Therapy (IRT) BEHAVIORAL

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.

Also known as: Cognitive Behavioral Therapy for Nightmares (CBT-N)

Treatment; Waitlist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Narcolepsy

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Disorders of Excessive Somnolence; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Jennifer Mundt, PhD

CONTACT

801-646-8287; DAWNstudy@utah.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Waitlist control

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 25, 2024
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)