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NCT05838430 · ClinicalTrials.gov registry record · Phase 4
Solriamfetol and CBT-I in Patients With Insomnia Disorder
A Phase 4 study of Insomnia, sponsored by University of Pennsylvania.
- Active
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT05838430 is a Phase 4 study of Insomnia that is active but no longer recruiting, run by University of Pennsylvania. The registered enrollment target is 60 participants, below the 170-participant average among 151 other Insomnia trials with a reported enrollment target (65% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05838430, a Phase 4 study of Insomnia, is active but no longer recruiting, sponsored by University of Pennsylvania.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
Medication is FDA approved. The objective of this project is to test the efficacy of solriamfetol for treating insomnia (alone and in combination with Cognitive Behavioral Therapy for Insomnia \[CBT-I\]). Ultimately, this study will test whether wake extension (regardless of how it is achieved) will consolidate sleep and improve sleep continuity.
Conditions Studied
Interventions
- OTHER Placebo
- BEHAVIORAL Cognitive Behavioral Therapy for Insomnia (CBT-I)
- OTHER Monitoring
- DRUG Solriamfetol 75 MG
Study Locations (1)
Pennsylvania
- University of Pennsylvania, Behavioral Sleep Medicine Program - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-07-31 |
| Est. Completion | 2026-04-30 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05838430
The ClinicalTrials.gov registry entry for NCT05838430 describes a study currently listed as active not recruiting, categorized as Phase 4. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 170-participant average among 151 other Insomnia trials with a reported enrollment target (65% lower). The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Insomnia appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT05838430 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05838430 about?
NCT05838430 is a clinical study titled "Solriamfetol and CBT-I in Patients With Insomnia Disorder". Medication is FDA approved. The objective of this project is to test the efficacy of solriamfetol for treating insomnia (alone and in combination with Cognitive Behavioral Therapy for Insomnia \[CBT-I\]). Ultimately, this study will test whether wake extension (regardless of how it is achieved) will...
What is the current status of trial NCT05838430?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2023-07-31. Estimated completion is 2026-04-30.
What conditions does trial NCT05838430 study?
This clinical trial studies the following conditions: Insomnia.
What interventions are being tested in trial NCT05838430?
The interventions under investigation include: Placebo (OTHER), Cognitive Behavioral Therapy for Insomnia (CBT-I) (BEHAVIORAL), Monitoring (OTHER), Solriamfetol 75 MG (DRUG).
Who is sponsoring clinical trial NCT05838430?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05838430 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.