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Solriamfetol and CBT-I in Patients With Insomnia Disorder

Insomnia Clinical Trial

Official title:
The Effects of Solriamfetol and CBT-I (Alone and in Combination) on Sleep Continuity, Sleepiness, Fatigue, and Performance in Patients With Insomnia Disorder

Clinical Trial 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.

Clinical Trial Description

The current proposal is for a one-year study to investigate whether solriamfetol can improve sleep continuity and daytime performance, alone and in combination with Cognitive Behavioral Therapy for Insomnia. It is expected (given a common mechanism [wake extension]) that both Cognitive Behavioral Therapy for Insomnia and treatment with solriamfetol will improve sleep continuity, and that such effects will potentially be additive. ;

Study Design

Related Conditions & MeSH terms

  • Insomnia
  • Sleep Initiation and Maintenance Disorders
Clinical Trial Details
NCT number NCT05838430
Study type Interventional
Source University of Pennsylvania
Contact Mark Seewald, BS
Phone 215-746-4378
Email Mark.Seewald@pennmedicine.upenn.edu
Status Recruiting
Phase Phase 4
Start date July 31, 2023
Completion date February 28, 2025
View Details
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