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Completed

NCT Number: NCT05709873

Narcolepsy Nightmare Study

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).

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Key information

Conditions

Narcolepsy Disorders of Excessive Somnolence Dyssomnias Mental Disorders Narcolepsy Type 1 Narcolepsy Type 2 Narcolepsy With Cataplexy Narcolepsy Without Cataplexy Nervous System Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Imagery Rehearsal Therapy

Behavioral

Therapy to reduce nightmares, delivered via videoconference sessions

Other names: IRT

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.

Other names: TDC

Primary outcomes

  1. Nightmare Frequency

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

    Frequency of nightmares as measured by daily diary

  2. Disturbing Dream and Nightmare Severity Scale

    Time frame: Baseline and posttreatment (up to 13 weeks)

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

Secondary outcomes

  1. Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale

    Time frame: Baseline and posttreatment (up to 13 weeks)

    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.

  2. Patient Reported Outcomes Measurement Information System (PROMIS) Depression Scale

    Time frame: Baseline and posttreatment (up to 13 weeks)

    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.

Other outcomes

  1. Dream Enactment Frequency

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

    Frequency of dream enactment as measured by daily diary

  2. Sleep Talking Frequency

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

    Frequency of sleep talking as measured by daily diary

  3. Lucid Dreams Without Control Frequency

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

    Frequency of lucid dreams without control as measured by daily diary

  4. Lucid Dreams With Control Frequency

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

    Frequency of lucid dreams with control as measured by daily diary

  5. Sleep-related Hallucinations Frequency

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

    Frequency of sleep-related hallucinations as measured by daily diary

  6. Sleep Paralysis Frequency

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

    Frequency of sleep paralysis as measured by daily diary

  7. Patient Reported Outcomes Measurement Information System (PROMIS) General Self-Efficacy

    Time frame: Baseline and posttreatment (up to 13 weeks)

    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.

  8. Patient Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy for Managing Symptoms

    Time frame: Baseline and posttreatment (up to 13 weeks)

    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.

  9. Nightmare Disorder Index

    Time frame: Baseline and posttreatment (up to 13 weeks)

    Measures nightmare severity. Minimum = 0, maximum = 20. Higher scores represent a worse severity of nightmares.

  10. Epworth Sleepiness Scale

    Time frame: Baseline and posttreatment (up to 13 weeks)

    Measures daytime sleepiness. Minimum = 0, maximum = 24. Higher scores represent worse daytime sleepiness.

  11. Hypersomnia Severity Index

    Time frame: Baseline and posttreatment (up to 13 weeks)

    Measures the severity of hypersomnia symptoms. Minimum = 0, maximum = 36. Higher scores represent worse symptoms.

  12. Functional Outcomes of Sleep Questionnaire-10

    Time frame: Baseline and posttreatment (up to 13 weeks)

    Measures daytime functioning related to hypersomnia. Minimum = 5, maximum = 20. Higher scores represent better functioning.

  13. Paris Arousal Disorders Severity Scale

    Time frame: Baseline and posttreatment (up to 13 weeks)

    Measures the severity of non-REM parasomnia symptoms. Minimum = 0, maximum = 50. Higher scores represent worse symptoms.

  14. Lucid Dream Skills Questionnaire (LUSK)

    Time frame: Baseline and posttreatment (up to 13 weeks)

    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.

  15. Dream Delusions Scale

    Time frame: Baseline and posttreatment (up to 13 weeks)

    Measures the severity of dream delusions. Minimum = 0, maximum = 12. Higher scores represent worse dream delusions.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

Behavioral Treatment of Narcolepsy-Related Nightmares

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 2, 2023
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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