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NCT03904238 · ClinicalTrials.gov registry record · NA
Psychosocial Adjunctive Treatment for Hypersomnia (PATH)
A NA study of Narcolepsy and Idiopathic Hypersomnia, sponsored by Northwestern University.
- Completed
- Registry status
- NA
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT03904238: Completed NA study of Narcolepsy and Idiopathic Hypersomnia, sponsored by Northwestern University.
NCT03904238 is a NA study of Narcolepsy and Idiopathic Hypersomnia that has completed, run by Northwestern University. The registered enrollment target is 35 participants, below the 378-participant average among 12 other Narcolepsy trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03904238, a NA study of Narcolepsy and Idiopathic Hypersomnia, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- NA
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study Summary
Current pharmacological treatments for chronic hypersomnia (narcolepsy, idiopathic hypersomnia) can effectively reduce excessive daytime sleepiness but a high proportion of patients experience depressive symptoms and poor health-related quality of life. Unfortunately, there are currently no psychosocial interventions that directly addresses this issue. Therefore, the overall goal of this project is to gather initial outcome data and work out methodological issues to determine if a future pragmatic clinical trial is warranted.
Primary Outcome
The PHQ is a 9-item self-report scale of depressive symptoms that has been validated to assess the severity of depression in clinical practice. PHQ-9 cut scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively.
Conditions Studied
Interventions
- BEHAVIORAL Cognitive-Behavior Therapy for Hypersomnia (CBT-H)
Study Locations (1)
Illinois
- Center for Circadian and Sleep Medicine, Northwestern University - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2018-12-10 |
| Est. Completion | 2019-10-07 |
| Phase | NA |
What the finished NCT03904238 record still lists
NCT03904238 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 378-participant average among 12 other Narcolepsy trials with a reported enrollment target (91% lower).
The record links to 2 conditions, with Narcolepsy appearing as the primary indexed condition, and to 1 intervention - of which Cognitive-Behavior Therapy for Hypersomnia (CBT-H) is the first listed.
NCT03904238 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT03904238 about?
NCT03904238 is a clinical study titled "Psychosocial Adjunctive Treatment for Hypersomnia (PATH)". Current pharmacological treatments for chronic hypersomnia (narcolepsy, idiopathic hypersomnia) can effectively reduce excessive daytime sleepiness but a high proportion of patients experience depressive symptoms and poor health-related quality of life. Unfortunately, there are currently no psychoso...
What is the current status of trial NCT03904238?
This trial is currently completed. It is a NA study. The enrollment target is 35 participants. The study started on 2018-12-10. Estimated completion is 2019-10-07.
What conditions does trial NCT03904238 study?
This clinical trial studies the following conditions: Narcolepsy, Idiopathic Hypersomnia.
What interventions are being tested in trial NCT03904238?
The interventions under investigation include: Cognitive-Behavior Therapy for Hypersomnia (CBT-H) (BEHAVIORAL).
Who is sponsoring clinical trial NCT03904238?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03904238 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03904238's enrollment target sits among peer trials
35 10th of 12 higher than 3 of 12 other Narcolepsy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Narcolepsy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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