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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: Active Phase 4 study of Insomnia, sponsored by University of Pennsylvania.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Reflected by total wake time \[time spent awake in bed\] as measured via a web based self-report Sleep Diary. This variable is calculated by summing the estimates for sleep latency (SL), sleep after wake onset (WASO), and early morning awakening (EMA).
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 |
What the registry record for NCT05838430 still lists
NCT05838430 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 170-participant average among 151 other Insomnia trials with a reported enrollment target (65% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Insomnia
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 NCT05838430's enrollment target sits among peer trials
60 89th of 151 higher than 58 of 151 other Insomnia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Insomnia 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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