Narcolepsy Nightmare Study

NCT05709873 | Completed Results

• 1 other identifier: STU00218129
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to test two behavioral treatments for nightmares in adults with narcolepsy. The main questions it aims to answer are:

• Is imagery rehearsal therapy (IRT) effective for narcolepsy-related nightmares?
• Does adding targeted dream control (TDC) to IRT make it more effective? Participants will be randomized to one of two treatment groups and will be asked to:
• Complete a daily log of sleep symptoms for up to 13 weeks.
• Attend 7 sessions of treatment.
• Complete questionnaires before and after treatment.
• Go to the research lab in Evanston, IL to complete a sleep study during a daytime nap (Chicago area residents only).

Conditions

Narcolepsy; Narcolepsy Type 1; Narcolepsy With Cataplexy; Narcolepsy Type 2; Narcolepsy Without Cataplexy

Outcome Measures

Primary Outcomes (2)

• Nightmare Frequency

  Frequency of nightmares as measured by daily diary

  Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11)

• Disturbing Dream and Nightmare Severity Scale

  Measures nightmare severity. Minimum = 0, maximum = 37. Higher scores represent a worse severity of nightmares.

  Baseline and posttreatment (up to 13 weeks)

Secondary Outcomes (2)

• Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale

  Baseline and posttreatment (up to 13 weeks)

• Patient Reported Outcomes Measurement Information System (PROMIS) Depression Scale

  Baseline and posttreatment (up to 13 weeks)

Other Outcomes (15)

• Dream Enactment Frequency

  Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11)

• Sleep Talking Frequency

  Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11)

• Lucid Dreams Without Control Frequency

  Baseline (assessed daily for 2 or 4 weeks) and posttreatment (assessed daily for 2 weeks beginning in week 9 or 11)

Study Arms (2)

Imagery rehearsal therapy (IRT)

EXPERIMENTAL

Participants randomized to this group will receive 7 sessions of IRT.

Behavioral: Imagery rehearsal therapy

Imagery rehearsal therapy and targeted dream control (IRT+TDC)

EXPERIMENTAL

Participants randomized to this group will receive 7 sessions of IRT+TDC.

Behavioral: Imagery rehearsal therapy; Behavioral: Targeted dream control

Interventions

Imagery rehearsal therapy BEHAVIORAL

Therapy to reduce nightmares, delivered via videoconference sessions

Also known as: IRT

Imagery rehearsal therapy (IRT); Imagery rehearsal therapy and targeted dream control (IRT+TDC)

Targeted dream control BEHAVIORAL

Therapy to reduce nightmares, delivered in videoconference sessions and lab session. Lab session will involve a sleep study during a daytime nap.

Also known as: TDC

Imagery rehearsal therapy and targeted dream control (IRT+TDC)

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
• Age 18 or older
• Speak English
• Live in the United States
• Receiving standard medical care for narcolepsy
• Sleep and psychiatric medications stable for at least 3 months
• Nightmare frequency of ≥3 times per week
• Nightmare Disorder Index score indicates probable nightmare disorder
• Able to attend a study appointment in Evanston, IL
• Able and willing to not take wake-promoting medications on day of lab visit

You may not qualify if:

• History of a neurological disorder that might alter EEG
• Currently engaged in sleep- or trauma-focused psychotherapy
• Previous behavioral treatment for nightmares
• Medical, psychiatric, or cognitive condition which would interfere with ability to engage in the treatment
• Untreated sleep apnea (AHI ≥ 5)

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Narcolepsy

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Jennifer Mundt
• Organization: Northwestern University

jennifer.mundt@northwestern.edu

312-503-2846

Study Officials

• Jennifer Mundt, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: February 2, 2023
• Study Start: February 22, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: June 30, 2026
• Results First Posted: June 30, 2026

Record last verified: 2026-04

Locations

US (1)