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Behavioural Intervention
Digital CBT-I Therapy for Chronic Insomnia (DREAM Trial)
N/A
Waitlist Available
Research Sponsored by Pear Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Insomnia as defined by an ISI score of 8 or above
Between 22 and 75 years old, inclusively
Must not have
Presence of an active and/or progressive physical illness (e.g., congestive-heart failure, chronic obstructive pulmonary disease, acute pain), neurological disorder (e.g., epilepsy) or neurological degenerative diseases (e.g., dementia, multiple sclerosis)
Diagnosis of a psychotic disorder or bipolar disorder or medical condition contraindicated by sleep restriction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up matched period
Awards & highlights
Summary
This trial is collecting data for a digital therapeutic that uses CBT-I to treat chronic insomnia. The trial is open to anyone with chronic insomnia.
Who is the study for?
This trial is for U.S. residents aged 22-75 with chronic insomnia, sleeping less than 6.5 hours per night and an ISI score of at least 8. Participants must have had insomnia symptoms for over three months and be able to give electronic consent using a mobile device.
What is being tested?
PEAR-003A, a digital therapeutic delivering CBT-I (Cognitive Behavioral Therapy for Insomnia), is being tested in this study through a remote, decentralized clinical trial lasting nine weeks to gather real-world data from individuals with chronic insomnia.
What are the potential side effects?
Since PEAR-003A is a digital therapeutic based on cognitive behavioral therapy rather than medication, it may not have traditional side effects but could include increased stress or anxiety due to changes in sleep patterns during the treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have insomnia with an ISI score of 8 or higher.
Select...
I am between 22 and 75 years old.
Select...
I have had trouble sleeping for at least 3 months.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a serious ongoing illness like heart failure or dementia.
Select...
I do not have a psychotic or bipolar disorder, nor a condition worsened by less sleep.
Select...
My job requires me to be highly alert, such as driving long distances or operating heavy machinery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 63, day 243, day 428, day 610, day 793
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 63, day 243, day 428, day 610, day 793
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Insomnia Severity Index (ISI)
Secondary study objectives
Evaluate PEAR-003A Adherence Data
Evaluate PEAR-003A Engagement Data
Examine change in anxiety symptoms
+1 moreOther study objectives
Describe user experience diary data
Describe user experience interviews
Describe user experience surveys
+6 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: PEAR-003AExperimental Treatment1 Intervention
Digital Therapeutic
Find a Location
Who is running the clinical trial?
Pear Therapeutics, Inc.Lead Sponsor
5 Previous Clinical Trials
267 Total Patients Enrolled
Abby DoctoleroStudy DirectorPear Therapeutics, Inc.
Paula WalkerStudy DirectorPear Therapeutics, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You sleep 6.5 hours or less each night.I have a serious ongoing illness like heart failure or dementia.I have insomnia with an ISI score of 8 or higher.I do not have a psychotic or bipolar disorder, nor a condition worsened by less sleep.I am between 22 and 75 years old.I have had trouble sleeping for at least 3 months.My job requires me to be highly alert, such as driving long distances or operating heavy machinery.I have not been treated for any sleep disorders I know I have.
Research Study Groups:
This trial has the following groups:- Group 1: PEAR-003A
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Chronic Insomnia Patient Testimony for trial: Trial Name: NCT04325464 — N/A
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