Narcolepsy Nightmare Study

NCT ID: NCT05709873

Last Updated: 2024-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-22

Study Completion Date

2024-04-30

Brief Summary

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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).

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Imagery rehearsal therapy (IRT)

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

Group Type EXPERIMENTAL

Imagery rehearsal therapy

Intervention Type BEHAVIORAL

Therapy to reduce nightmares, delivered via videoconference sessions

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

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

Group Type EXPERIMENTAL

Imagery rehearsal therapy

Intervention Type BEHAVIORAL

Therapy to reduce nightmares, delivered via videoconference sessions

Targeted dream control

Intervention Type BEHAVIORAL

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

Interventions

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Imagery rehearsal therapy

Therapy to reduce nightmares, delivered via videoconference sessions

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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IRT TDC

Eligibility Criteria

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Inclusion Criteria

* 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

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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jennifer Mundt, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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STU00218129

Identifier Type: -

Identifier Source: org_study_id

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