Narcolepsy Clinical Trial
— DAWNOfficial title:
Imagery Rehearsal Therapy for the Treatment of Nightmares in Narcolepsy: A Pilot Randomized Controlled Trial
Verified date | April 2024 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this clinical trial is learn whether a behavioral (non-medication) treatment can reduce nightmares in adults with narcolepsy. All participants will receive the treatment and will complete three assessments. Half of the participants will receive the treatment after the first assessment, and half will receive it after the second assessment.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | September 2026 |
Est. primary completion date | September 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Diagnosis of narcolepsy type 1 or narcolepsy type 2 - Nightmare frequency of =1 times per week - Age 18 or older - Able to speak, read, and write in English - Live in the United States - Sleep and medications stable for = 1 month and willing to keep medications stable for the duration of the study Exclusion Criteria: - Currently engaged in trauma- or sleep-related psychotherapy - Previous behavioral treatment for nightmares - Medical, psychiatric, or cognitive condition which would interfere with ability to engage in the treatment - Untreated moderate-severe sleep apnea |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Northwestern University |
Leu-Semenescu S, Maranci JB, Lopez R, Drouot X, Dodet P, Gales A, Groos E, Barateau L, Franco P, Lecendreux M, Dauvilliers Y, Arnulf I. Comorbid parasomnias in narcolepsy and idiopathic hypersomnia: more REM than NREM parasomnias. J Clin Sleep Med. 2022 May 1;18(5):1355-1364. doi: 10.5664/jcsm.9862. — View Citation
Pisko J, Pastorek L, Buskova J, Sonka K, Nevsimalova S. Nightmares in narcolepsy: underinvestigated symptom? Sleep Med. 2014 Aug;15(8):967-72. doi: 10.1016/j.sleep.2014.03.006. Epub 2014 Apr 13. — View Citation
Schredl M. Editorial for "Nightmares in narcolepsy--under-investigated symptom?" (SLEEP-D-13-00591) Understanding and treating nightmares in patients with narcolepsy. Sleep Med. 2014 Aug;15(8):851-2. doi: 10.1016/j.sleep.2014.05.003. Epub 2014 May 16. No abstract available. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disturbing Dream and Nightmare Severity Index (DDNSI) | The DDNSI is a questionnaire which measures the severity of nightmares. | 2 weeks, completed at each of the three assessments (baseline, 10 weeks, 19 weeks) | |
Primary | Nightmare frequency (sleep diary) | The number of nightmares experienced each day will be collected on daily sleep diaries completed during each assessment period. | 2 weeks, completed at each of the three assessments (baseline, 10 weeks, 19 weeks) | |
Secondary | PROMIS Anxiety | Questionnaire which measures the severity of anxiety symptoms. | 1 week, completed at each of the three assessments (baseline, 10 weeks, 19 weeks) | |
Secondary | PROMIS Depression | Questionnaire which measures the severity of depressive symptoms. | 1 week, completed at each of the three assessments (baseline, 10 weeks, 19 weeks) |
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 |
NCT01681121 -
A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy
|
Phase 2 | |
Completed |
NCT01789398 -
Patient Narcoleptic Treated With BF2.649 (Pitolisant) in add-on to Sodium Oxybate (HARMONY IV)
|
Phase 3 | |
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 |
NCT00107796 -
Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy
|
Phase 3 | |
Completed |
NCT00132873 -
Trial of Xyrem® (Sodium Oxybate) for the Treatment of 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'
|