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NCT05709873 Clinical Trial

Narcolepsy Nightmare Study

Narcolepsy Clinical Trial

Official title:
Behavioral Treatment of Narcolepsy-Related Nightmares

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05709873
Other study ID # STU00218129
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 22, 2023
Est. completion date April 30, 2024

Study information
Verified date June 2024
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 7
Est. completion date April 30, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Imagery rehearsal therapy
Therapy to reduce nightmares, delivered via videoconference sessions
• 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.

Locations
Country Name City State
United States Northwestern University Chicago Illinois

Sponsors (1)
Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Daily diary Nightmare severity/frequency Duration of study (11-13 weeks)
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