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 Details — Status: Recruiting

Administrative data

• NCT number: NCT05838430
• Other study ID #: 850945
• Status: Recruiting
• Phase: Phase 4
• Start date: July 31, 2023
• Est. completion date: February 28, 2025

Study information

• Verified date: August 2023
• Source: University of Pennsylvania
• Contact: Mark Seewald, BS
• Phone: 215-746-4378
• Email: Mark.Seewald[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 28, 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• Solriamfetol 75 MG
Solriamfetol (trade name Sunosi), is a norepinephrine-dopamine reuptake inhibitor available in 75mg and 150mg tablets for oral administration during the day. Solriamfetol's primary indication is to treat excessive daytime sleepiness (EDS) in patients diagnosed with obstructive sleep apnea or Narcolepsy. It binds to the dopamine and the norepinephrine transporters with affinities (Ki) of 14.2 µM and 3.7 µM, respectively),does not undergo significant metabolism in humans, and has a Tmax of ~2 hours (range 1.25-3.0 hours) and a T1/2 of ~7.1 hours.

Behavioral:
• Cognitive Behavioral Therapy for Insomnia (CBT-I)
Treatment will be conducted via a HIPAA compliant video link (Zoom). Sessions 1-8 will follow our published protocol (published in 2005 by Springer). Each session will be conducted individually and have a singular focus per session. All sessions following the delivery of sleep restriction therapy & stimulus control instructions (post Session 2) will include, as needed, management of non-adherence and/or time-in-bed titration.

Other:
• Monitoring
No CBT-I will be administered, however, the tracking system used for CBT-I will be used for all subject conditions. This includes a sleep disorder symptoms screener, the administration of several questionnaires on a weekly basis, and the administration of daily sleep diaries online or via iPhone. Note: it is a common effect that regular monitoring of this type produces perceived clinical benefit.
• Placebo
Placebo, identical in appearance to the active drug.

Locations

Country	Name	City	State
United States	University of Pennsylvania, Behavioral Sleep Medicine Program	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Axsome Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep Continuity	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).	End of Treatment (12 Weeks)
Secondary	Insomnia Severity	As measured by the Insomnia Severity Index. Range of scores = 0 to 28, with a higher score indicating more severe insomnia.	End of Treatment (12 Weeks)
Secondary	Daytime Sleepiness	As measured by the Epworth Sleepiness Scale. Range of scores = 0 to 24, with a higher score indicating more severe daytime sleepiness.	End of Treatment (12 Weeks)
Secondary	Fatigue	As measured by Fatigue Severity Scale. Range of scores = 9 to 63, with a higher score indicating more severe fatigue.	End of Treatment (12 Weeks)
Secondary	Adherence to "sleep rescheduling"	Sleep rescheduling is a core component of Cognitive Behavioral Therapy for Insomnia, and adherence to it will be measured by the difference between prescribed time to bed and time out of bed and actual time to bed and time out of bed as reported on daily sleep diary entries.	Throughout treatment (over 8 weeks)
Secondary	Daytime Function	As measured by Functional Outcomes of Sleep Questionnaire (FOSQ-10) Range of scores = 10-40, with lower scores indicating more severe daytime function impairment.	End of Treatment (12 Weeks)
Secondary	Mood Disturbance	Total Mood Disturbance Score on Profile of Mood States Range of scores = 0-20, with higher scores indicating more severe mood disturbance.	End of Treatment (12 Weeks)
Secondary	Alertness	As measured by average response time (milliseconds) on a Psychomotor Vigilance Test.; Range of scores = 0 to 180000 milliseconds, with a higher score indicating lower levels of alertness.	Throughout treatment (over 8 weeks)