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Narcolepsy Nightmare Study

Primary Purpose

Narcolepsy, Narcolepsy Type 1, Narcolepsy With Cataplexy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Imagery rehearsal therapy
Targeted dream control
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Narcolepsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Northwestern UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Imagery rehearsal therapy (IRT)

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

Arm Description

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

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

Outcomes

Primary Outcome Measures

Daily diary
Nightmare severity/frequency

Secondary Outcome Measures

Full Information

First Posted
January 24, 2023
Last Updated
June 21, 2023
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT05709873
Brief Title
Narcolepsy Nightmare Study
Official Title
Behavioral Treatment of Narcolepsy-Related Nightmares
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2023 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Narcolepsy, Narcolepsy Type 1, Narcolepsy With Cataplexy, Narcolepsy Type 2, Narcolepsy Without Cataplexy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Imagery rehearsal therapy (IRT)
Arm Type
Experimental
Arm Description
Participants randomized to this group will receive 7 sessions of IRT.
Arm Title
Imagery rehearsal therapy and targeted dream control (IRT+TDC)
Arm Type
Experimental
Arm Description
Participants randomized to this group will receive 7 sessions of IRT+TDC.
Intervention Type
Behavioral
Intervention Name(s)
Imagery rehearsal therapy
Other Intervention Name(s)
IRT
Intervention Description
Therapy to reduce nightmares, delivered via videoconference sessions
Intervention Type
Behavioral
Intervention Name(s)
Targeted dream control
Other Intervention Name(s)
TDC
Intervention Description
Therapy to reduce nightmares, delivered in videoconference sessions and lab session. Lab session will involve a sleep study during a daytime nap.
Primary Outcome Measure Information:
Title
Daily diary
Description
Nightmare severity/frequency
Time Frame
Duration of study (11-13 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Mundt, PhD
Phone
312-503-2846
Email
NightmareStudy@northwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Mundt, PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Mundt, PhD
Email
NightmareStudy@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Jennifer Mundt, PhD
First Name & Middle Initial & Last Name & Degree
Ken Paller, PhD

12. IPD Sharing Statement

Learn more about this trial

Narcolepsy Nightmare Study

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