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Central Nervous System Stimulant
Solriamfetol + CBT-I for Insomnia
Phase 4
Recruiting
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of treatment (12 weeks)
Awards & highlights
Study Summary
This trial will test if a medication and/or therapy can help treat insomnia and improve sleep quality.
Who is the study for?
This trial is for adults with Insomnia Disorder as per DSM-5, experiencing specific sleep disturbances more than three nights a week for over six months. They must have daytime impairment and prefer to sleep between 10 PM and 8 AM. Excluded are pregnant or breastfeeding individuals, those with unstable health conditions, no internet access, night shift workers, renal issues, severe heart disease or hypertension, other sleep disorders, using certain medications or substances.Check my eligibility
What is being tested?
The study tests the effectiveness of solriamfetol (a medication) alone and combined with Cognitive Behavioral Therapy for Insomnia (CBT-I). It aims to see if extending wakefulness can improve sleep quality. Participants will be monitored and may receive either the drug at a specified dose, CBT-I therapy sessions, placebo pills that contain no active drug or just monitoring without intervention.See study design
What are the potential side effects?
Solriamfetol may cause side effects such as headache, nausea, increased blood pressure or heart rate; trouble falling asleep; decreased appetite; anxiety; dizziness; dry mouth. The severity of these side effects can vary among individuals.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ end of treatment (12 weeks)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of treatment (12 weeks)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Sleep Continuity
Secondary outcome measures
Adherence to "sleep rescheduling"
Alertness
Daytime Function
+4 moreTrial Design
4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Solriamfetol+ CBT-IExperimental Treatment2 Interventions
Group II: Solriamfetol OnlyExperimental Treatment2 Interventions
Group III: Placebo + CBT-IActive Control2 Interventions
Group IV: Placebo OnlyPlacebo Group2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Solriamfetol 75 MG
2021
Completed Phase 3
~70
Cognitive Behavioral Therapy for Insomnia (CBT-I)
2014
N/A
~720
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Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,882,227 Total Patients Enrolled
15 Trials studying Insomnia
4,556 Patients Enrolled for Insomnia
Axsome Therapeutics, Inc.Industry Sponsor
28 Previous Clinical Trials
8,132 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I often feel tired or sleepy during the day.I often feel very tired or sleepy during the day.My condition has lasted for more than 6 months.I experience symptoms of sleep disorders other than insomnia.I do not have any unstable medical or mental health conditions.I have serious heart disease or high blood pressure that medication can't control.I am taking medication for sleep problems or medication that causes sleep problems.I often struggle to fall asleep, wake up frequently, or sleep less than 6 hours.I have been experiencing the problem for more than 3 nights a week.I have undergone or am undergoing cognitive behavioral therapy for insomnia.My kidney function is not normal.I use medication to help me sleep.My health issue has lasted for more than 6 months.I have trouble sleeping, taking over 30 minutes to fall asleep or waking up often.My issue occurs more than 3 nights a week.You have been diagnosed with Insomnia Disorder according to the guidelines in the DSM-5.You usually sleep at night between 10:00 PM and 8:00 AM.
Research Study Groups:
This trial has the following groups:- Group 1: Solriamfetol+ CBT-I
- Group 2: Solriamfetol Only
- Group 3: Placebo + CBT-I
- Group 4: Placebo Only
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who is eligible for participation in this medical study?
"This trial, which has a target recruitment of 60 individuals, is seeking applicants aged 25 to 60 who suffer from insomnia."
Answered by AI
Do you have any age restrictions for participants in this trial?
"The inclusion criteria for this medical trial dictate that participants must between the ages of 25 and 60."
Answered by AI
Does this research still have openings for participants?
"According to information hosted on clinicaltrials.gov, it is evident that this medical trial has stopped recruiting patients as of April 28th 2023; however, 223 other studies are actively enrolling participants right now. This investigation was initially posted in May 1st 2023."
Answered by AI
To what extent is Solriamfetol+ CBT-I a potential risk to human health?
"Our analysis at Power gives Solriamfetol+ CBT-I a score of 3, as this treatment is officially approved by the relevant regulatory bodies and has thus gone through multiple safety checks."
Answered by AI
Who else is applying?
What site did they apply to?
University of Pennsylvania, Behavioral Sleep Medicine Program
What portion of applicants met pre-screening criteria?
Met criteria
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