ACTIVE_NOT_RECRUITING

Solriamfetol and CBT-I in Patients With Insomnia Disorder

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Conditions

InsomniaMedicationFatiguePerformanceCBT-I

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-07-31
Study Completion:2026-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05838430

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥ 30 minutes to fall asleep (SL) and/or ≥ 2 awakenings per night of ≥ 15 minutes duration and/or wake after sleep onset (WASO) time of ≥ 30 minutes where total sleep time (TST) did not exceed 6 hours (unless sleep efficiency \[SE\] is ≤ 80%).
  2. * The problem is present for \> 3 nights per week.
  3. * The problem duration exceeds ≥ 6 months.
  4. * The complaint of impaired daytime function must include, although not limited to, the report of daytime fatigue, sleepiness, or both.
  5. * Preferred regular sleep phase between 10:00 PM and 8:00 AM
  6. * Must garner physician's assent from their primary care clinician
  1. * Use of medication expressly for the purpose of falling or staying asleep (e.g., trazodone/ desyrel, melatonin, Tylenol PM, Nyquil, Benadryl).
  2. * Night shift work
  3. * Compromised renal function
  4. * Major Coronary Artery Disease and/or uncontrolled (with meds) Hypertension
  5. * Planning to become pregnant, pregnant, and/or breastfeeding
  6. * Unstable medical or psychiatric illness
  7. * Symptoms suggestive of sleep disorders other than insomnia
  8. * Polysomnographic data indicating sleep disorders other than insomnia
  9. * Evidence of active illicit substance use, abuse, or dependence
  10. * Use of CNS active medications that are for treatment of insomnia or are thought to have caused insomnia as a side effect
  11. * Inadequate language comprehension
  12. * Current or past experience with CBT-I
  13. * No access to the computers, I-Pads, or the internet

Contacts and Locations

Study Locations (Sites)

University of Pennsylvania, Behavioral Sleep Medicine Program
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-31
Study Completion Date2026-04-30

Study Record Updates

Study Start Date2023-07-31
Study Completion Date2026-04-30

Terms related to this study

Keywords Provided by Researchers

  • Insomnia
  • Medication
  • Fatigue
  • Performance
  • CBT-I

Additional Relevant MeSH Terms

  • Insomnia