Narcolepsy Nightmare Study

June 10, 2024 updated by: Northwestern University

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Daily diary
Time Frame: Duration of study (11-13 weeks)
Nightmare severity/frequency
Duration of study (11-13 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Jennifer Mundt, PhD, Northwestern University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 12, 2024

Last Update Submitted That Met QC Criteria

June 10, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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