Clinical Trials Logo
  1. Home
  2. Narcolepsy
  3. NCT05709873
  4. Details
NCT05709873 Clinical Trial

Narcolepsy Nightmare Study

Narcolepsy Clinical Trial

Official title:
Behavioral Treatment of Narcolepsy-Related Nightmares

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05709873
Other study ID # STU00218129
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 22, 2023
Est. completion date May 2024

Study information
Verified date March 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 Active, not recruiting
Enrollment 6
Est. completion date May 2024
Est. primary completion date May 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)
See also
  Status Clinical Trial Phase
Completed NCT04072380 - A Study to Evaluate Safety, and Efficacy of SUVN-G3031 (Samelisant) in Patients With Narcolepsy With and Without Cataplexy Phase 2
Withdrawn NCT03626727 - Evaluation of the Efficacy of Sodium Oxybate (Xyrem®) in Treatment of Post-traumatic Narcolepsy and Post-traumatic Hypersomnia Early Phase 1
Completed NCT02821715 - Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients Phase 2
Completed NCT01789398 - Patient Narcoleptic Treated With BF2.649 (Pitolisant) in add-on to Sodium Oxybate (HARMONY IV) Phase 3
Completed NCT01681121 - A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy Phase 2
Completed NCT00174174 - Provigil (Modafinil) Study by Taiwan Biotech Co. N/A
Completed NCT05059223 - A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy Phase 3
Completed NCT04923594 - Four-week Study of the Safety and Efficacy of NLS-2 (Mazindol Extended Release) in the Treatment of Narcolepsy Phase 2
Recruiting NCT06279247 - Proteomics and Metabolomics of Body Fluid in Patients With Narcolepsy
Completed NCT04647903 - Study to Evaluate the Abuse Liability, Pharmacokinetics, Safety and Tolerability of an Abuse-Deterrent d-Amphetamine Sulfate Immediate Release Formulation (ADAIR) Phase 1
Completed NCT03267303 - A Study to Evaluate the Safety and Efficacy of TS-091 in Patients With Narcolepsy Phase 2
Completed NCT03173378 - Evaluation of Academic and Professional Trajectories of Narcoleptic Patients
Completed NCT05055024 - An Open Label Study of NLS-2 (Mazindol Extended Release) in Subjects With Narcolepsy Phase 2
Completed NCT01067235 - Efficacy and Safety Study of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With Narcolespy Phase 3
Completed NCT00228566 - Study to Assess Patient Reported Outcomes With Armodafinil Treatment for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome Phase 3
Completed NCT00132873 - Trial of Xyrem® (Sodium Oxybate) for the Treatment of Narcolepsy Phase 3
Completed NCT00107796 - Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy Phase 3
Completed NCT00107848 - PROVIGIL® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome Phase 3
Enrolling by invitation NCT05113745 - A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy Phase 3
Suspended NCT04419792 - 'A Profile of Physical Performance Variables in an Out-patient Adult Population With Narcolepsy'