Narcolepsy Nightmare Study

Behavioral Treatment of Narcolepsy-Related Nightmares

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).

Study Overview

• Status: Completed
• Conditions: Narcolepsy; Narcolepsy Type 1; Narcolepsy Without Cataplexy; Narcolepsy With Cataplexy; Narcolepsy Type 2
• Intervention / Treatment: Behavioral: Imagery rehearsal therapy; Behavioral: Targeted dream control

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria (all participants):

• 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

Inclusion Criteria (Chicago area participants):

• Able to attend a study appointment in Evanston, IL
• Able and willing to not take wake-promoting medications on day of lab visit

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Imagery rehearsal therapy (IRT); Participants randomized to this group will receive 7 sessions of IRT.	Behavioral: Imagery rehearsal therapy; Therapy to reduce nightmares, delivered via videoconference sessions; Other Names: IRT
Experimental: Imagery rehearsal therapy and targeted dream control (IRT+TDC); Participants randomized to this group will receive 7 sessions of IRT+TDC.	Behavioral: Imagery rehearsal therapy; Therapy to reduce nightmares, delivered via videoconference sessions; Other Names: IRT; Behavioral: Targeted dream control; Therapy to reduce nightmares, delivered in videoconference sessions and lab session. Lab session will involve a sleep study during a daytime nap.; Other Names: TDC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale	Measures symptoms using Computer Adaptive Testing (CAT) with higher scores reflecting more anxiety symptoms (worse outcome). Population mean (T-score) of 50 with a standard deviation of 10.	Baseline and posttreatment (up to 13 weeks)
Patient Reported Outcomes Measurement Information System (PROMIS) Depression Scale	Measures symptoms using Computer Adaptive Testing (CAT) with higher scores reflecting more depressive symptoms (worse outcome). Population mean (T-score) of 50 with a standard deviation of 10.	Baseline and posttreatment (up to 13 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dream Enactment Frequency	Frequency of dream enactment 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)
Sleep Talking Frequency	Frequency of sleep talking 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)
Lucid Dreams Without Control Frequency	Frequency of lucid dreams without control 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)
Lucid Dreams With Control Frequency	Frequency of lucid dreams with control 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)
Sleep-related Hallucinations Frequency	Frequency of sleep-related hallucinations 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)
Sleep Paralysis Frequency	Frequency of sleep paralysis 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)
Patient Reported Outcomes Measurement Information System (PROMIS) General Self-Efficacy	Measures symptoms using Computer Adaptive Testing (CAT) with higher scores reflecting more self-efficacy (better outcome). Population mean (T-score) of 50 with a standard deviation of 10.	Baseline and posttreatment (up to 13 weeks)
Patient Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Symptoms	Measures symptoms using Computer Adaptive Testing (CAT) with higher scores reflecting more self-efficacy (better outcome). Population mean (T-score) of 50 with a standard deviation of 10.	Baseline and posttreatment (up to 13 weeks)
Nightmare Disorder Index	Measures nightmare severity. Minimum = 0, maximum = 20. Higher scores represent a worse severity of nightmares.	Baseline and posttreatment (up to 13 weeks)
Epworth Sleepiness Scale	Measures daytime sleepiness. Minimum = 0, maximum = 24. Higher scores represent worse daytime sleepiness.	Baseline and posttreatment (up to 13 weeks)
Hypersomnia Severity Index	Measures the severity of hypersomnia symptoms. Minimum = 0, maximum = 36. Higher scores represent worse symptoms.	Baseline and posttreatment (up to 13 weeks)
Functional Outcomes of Sleep Questionnaire-10	Measures daytime functioning related to hypersomnia. Minimum = 5, maximum = 20. Higher scores represent better functioning.	Baseline and posttreatment (up to 13 weeks)
Paris Arousal Disorders Severity Scale	Measures the severity of non-REM parasomnia symptoms. Minimum = 0, maximum = 50. Higher scores represent worse symptoms.	Baseline and posttreatment (up to 13 weeks)
Lucid Dream Skills Questionnaire (LUSK)	The Lucid Dream Skills Questionnaire (LUSK) measures the frequency of lucid dreaming. The LUSK total score ranges from 0-4 (the mean of the item scores), with higher scores representing a higher frequency of lucid dreaming. In general, a higher frequency of lucid dreaming is not inherently "better" or "worse." For the purpose of this trial, one of the intervention components (Targeted Dream Control) attempted to increase lucid dreaming, so a higher score for this trial would indicate an improvement.	Baseline and posttreatment (up to 13 weeks)
Dream Delusions Scale	Measures the severity of dream delusions. Minimum = 0, maximum = 12. Higher scores represent worse dream delusions.	Baseline and posttreatment (up to 13 weeks)

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Jennifer Mundt, PhD, Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2023
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: January 24, 2023
• First Submitted That Met QC Criteria: January 24, 2023
• First Posted (Actual): February 2, 2023

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Disorders of Excessive Somnolence; Narcolepsy
• Other Study ID Numbers: STU00218129

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No