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| Name | Class |
|---|---|
| Axsome Therapeutics, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Solriamfetol+ CBT-I | Experimental |
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| Solriamfetol Only | Experimental |
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| Placebo + CBT-I | Active Comparator |
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| Placebo Only | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solriamfetol 75 MG | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Daytime Sleepiness | As measured by the Epworth Sleepiness Scale. Range of scores = 0 to 24, with a higher score indicating more severe daytime sleepiness. |
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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:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania, Behavioral Sleep Medicine Program | Philadelphia | Pennsylvania | 19104 | United States |
The investigators do not plan on sharing IPD with other researchers.
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000623308 | solriamfetol |
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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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).
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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:
All conditions engage in monitoring and assessment.
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| Cognitive Behavioral Therapy for Insomnia (CBT-I) | Behavioral | 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. |
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| Monitoring | Other | 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. |
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| Placebo | Other | Placebo, identical in appearance to the active drug. |
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| End of Treatment (12 Weeks) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| D001523 |
| Mental Disorders |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |