Clincosm LogoSign in Get a demo

Narcolepsy Nightmare Study

Sponsor
Northwestern University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05709873
Collaborator
(none)
10
Enrollment
1
Location
2
Arms
6
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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 5-7 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Imagery rehearsal therapy
  • Behavioral: Targeted dream control
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Behavioral Treatment of Narcolepsy-Related Nightmares
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Imagery rehearsal therapy (IRT)

Participants randomized to this group will receive 5 sessions of IRT.

Behavioral: Imagery rehearsal therapy
Therapy to reduce nightmares, delivered in 5 videoconference sessions
Other Names:
  • IRT

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

    Participants randomized to this group will receive 5 sessions of IRT followed by 2 sessions of TDC.

    Behavioral: Imagery rehearsal therapy
    Therapy to reduce nightmares, delivered in 5 videoconference sessions
    Other Names:
  • IRT

    • Behavioral: Targeted dream control
    Therapy to reduce nightmares, delivered in 1 videoconference session and 1 lab session. Lab session will involve a sleep study during a daytime nap.
    Other Names:
  • TDC

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Daily diary [Duration of study (11-13 weeks)]

      Nightmare severity/frequency

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosis of narcolepsy

    • Age 18 or older

    • Speak English

    • Live in the United States and able to attend study appointments in Evanston, IL

    • 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 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 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Northwestern University Chicago Illinois United States 60611

    Sponsors and Collaborators

    • Northwestern University

    Investigators

    • Principal Investigator: Jennifer Mundt, PhD, Northwestern University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jennifer Mundt, PhD, Assistant Professor, Northwestern University
    ClinicalTrials.gov Identifier:
    NCT05709873
    Other Study ID Numbers:
    • STU00218129
    First Posted:
    Feb 2, 2023
    Last Update Posted:
    Feb 2, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Narcolepsy
    Cataplexy

    Study Results

    No Results Posted as of Feb 2, 2023