search
Back to results

Solriamfetol and CBT-I in Patients With Insomnia Disorder

Primary Purpose

Insomnia

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Solriamfetol 75 MG
Cognitive Behavioral Therapy for Insomnia (CBT-I)
Monitoring
Placebo
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring Insomnia, Medication, Fatigue, Performance, CBT-I

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pennsylvania, Behavioral Sleep Medicine ProgramRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

Solriamfetol+ CBT-I

Solriamfetol Only

Placebo + CBT-I

Placebo Only

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Insomnia Severity
As measured by the Insomnia Severity Index. Range of scores = 0 to 28, with a higher score indicating more severe insomnia.
Daytime Sleepiness
As measured by the Epworth Sleepiness Scale. Range of scores = 0 to 24, with a higher score indicating more severe daytime sleepiness.
Fatigue
As measured by Fatigue Severity Scale. Range of scores = 9 to 63, with a higher score indicating more severe fatigue.
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.
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.
Mood Disturbance
Total Mood Disturbance Score on Profile of Mood States Range of scores = 0-20, with higher scores indicating more severe mood disturbance.
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.

Full Information

First Posted
March 6, 2023
Last Updated
August 17, 2023
Sponsor
University of Pennsylvania
Collaborators
Axsome Therapeutics, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05838430
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 31, 2023 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
February 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Axsome Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia
Keywords
Insomnia, Medication, Fatigue, Performance, CBT-I

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
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).
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Blinding only applies to the medication arm. The randomization schedule was developed by our statistician and sent directly to research pharmacy for implementation. The four arms are as follows: Solriamfetol + CBT-I Placebo + CBT-I Solriamfetol Only Placebo Only All conditions engage in monitoring and assessment.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Solriamfetol+ CBT-I
Arm Type
Experimental
Arm Title
Solriamfetol Only
Arm Type
Experimental
Arm Title
Placebo + CBT-I
Arm Type
Active Comparator
Arm Title
Placebo Only
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Solriamfetol 75 MG
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for Insomnia (CBT-I)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Monitoring
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo, identical in appearance to the active drug.
Primary Outcome Measure Information:
Title
Sleep Continuity
Description
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).
Time Frame
End of Treatment (12 Weeks)
Secondary Outcome Measure Information:
Title
Insomnia Severity
Description
As measured by the Insomnia Severity Index. Range of scores = 0 to 28, with a higher score indicating more severe insomnia.
Time Frame
End of Treatment (12 Weeks)
Title
Daytime Sleepiness
Description
As measured by the Epworth Sleepiness Scale. Range of scores = 0 to 24, with a higher score indicating more severe daytime sleepiness.
Time Frame
End of Treatment (12 Weeks)
Title
Fatigue
Description
As measured by Fatigue Severity Scale. Range of scores = 9 to 63, with a higher score indicating more severe fatigue.
Time Frame
End of Treatment (12 Weeks)
Title
Adherence to "sleep rescheduling"
Description
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.
Time Frame
Throughout treatment (over 8 weeks)
Title
Daytime Function
Description
As measured by Functional Outcomes of Sleep Questionnaire (FOSQ-10) Range of scores = 10-40, with lower scores indicating more severe daytime function impairment.
Time Frame
End of Treatment (12 Weeks)
Title
Mood Disturbance
Description
Total Mood Disturbance Score on Profile of Mood States Range of scores = 0-20, with higher scores indicating more severe mood disturbance.
Time Frame
End of Treatment (12 Weeks)
Title
Alertness
Description
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.
Time Frame
Throughout treatment (over 8 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mark Seewald, BS
Phone
215-746-4378
Email
Mark.Seewald@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Perlis, PHD
Phone
215-746-3577
Email
mperlis@upenn.edu
Facility Information:
Facility Name
University of Pennsylvania, Behavioral Sleep Medicine Program
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Seewald, BS
First Name & Middle Initial & Last Name & Degree
Michael L Perlis, PHD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The investigators do not plan on sharing IPD with other researchers.

Learn more about this trial

Solriamfetol and CBT-I in Patients With Insomnia Disorder

We'll reach out to this number within 24 hrs