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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 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.

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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.

Interventions

  • BEHAVIORAL Cognitive-Behavior Therapy for Hypersomnia (CBT-H)

Study Locations (1)

Illinois

  • Center for Circadian and Sleep Medicine, Northwestern University - Chicago

Trial Details

FieldValue
Enrollment Target 35 participants
Start Date 2018-12-10
Est. Completion 2019-10-07
Phase NA

Sponsor

Northwestern University

1,209 total trials

What the Registry Record Tells You About NCT03904238

The ClinicalTrials.gov registry entry for NCT03904238 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 378-participant average among 12 other Narcolepsy trials with a reported enrollment target (91% lower). The listed sponsor is Northwestern University, which has 1,209 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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