Clinical trial NCT05838430: Solriamfetol and CBT-I in Patients With Insomnia Disorder
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Insomnia
Keywords: Insomnia
Medication
Fatigue
Performance
CBT-I
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Axsome Therapeutics, Inc.
First posted: 2023-05-01
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: A 2x2 mixed model design. The two factors will be 1) treatment (+/- solriamfetol and +/- CBT-I) and 2) Time (pre-post assessment, with additional follow-up data).
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

• Participants will meet the diagnostic criteria for Insomnia Disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5).

In addition, the complaint of disturbed sleep will meet the following criteria:

* ≥ 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%).
* The problem is present for \> 3 nights per week.
* The problem duration exceeds ≥ 6 months.
* The complaint of impaired daytime function must include, although not limited to, the report of daytime fatigue, sleepiness, or both.
* Preferred regular sleep phase between 10:00 PM and 8:00 AM
* Must garner physician's assent from their primary care clinician

Exclusion Criteria:

* Use of medication expressly for the purpose of falling or staying asleep (e.g., trazodone/ desyrel, melatonin, Tylenol PM, Nyquil, Benadryl).
* Night shift work
* Compromised renal function
* Major Coronary Artery Disease and/or uncontrolled (with meds) Hypertension
* Planning to become pregnant, pregnant, and/or breastfeeding
* Unstable medical or psychiatric illness
* Symptoms suggestive of sleep disorders other than insomnia
* Polysomnographic data indicating sleep disorders other than insomnia
* Evidence of active illicit substance use, abuse, or dependence
* Use of CNS active medications that are for treatment of insomnia or are thought to have caused insomnia as a side effect
* Inadequate language comprehension
* Current or past experience with CBT-I
* No access to the computers, I-Pads, or the internet

Primary outcomes:
measure: Sleep Continuity
timeFrame: End of Treatment (12 Weeks)
Secondary outcomes:
measure: Insomnia Severity
timeFrame: End of Treatment (12 Weeks)
measure: Daytime Sleepiness
timeFrame: End of Treatment (12 Weeks)
measure: Fatigue
timeFrame: End of Treatment (12 Weeks)
measure: Adherence to "sleep rescheduling"
timeFrame: Throughout treatment (over 8 weeks)
measure: Daytime Function
timeFrame: End of Treatment (12 Weeks)
measure: Mood Disturbance
timeFrame: End of Treatment (12 Weeks)
measure: Alertness
timeFrame: Throughout treatment (over 8 weeks)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania, Behavioral Sleep Medicine Program
state: Pennsylvania
Study officials:
References: