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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up matched period

Awards & highlights

DREAM Trial 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.Check my eligibility

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.See study design

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.

DREAM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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.

DREAM Trial 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 63, day 243, day 428, day 610, day 793 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Insomnia Severity Index (ISI)

Secondary outcome measures

Evaluate PEAR-003A Adherence Data

Evaluate PEAR-003A Engagement Data

Examine change in anxiety symptoms

+1 more

Other outcome measures

Describe user experience diary data

Describe user experience interviews

Describe user experience surveys

+6 more

DREAM Trial Design

1Treatment groups

Experimental Treatment

Group I: PEAR-003AExperimental Treatment1 Intervention

Digital Therapeutic

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Pear Therapeutics, Inc.Lead Sponsor

5 Previous Clinical Trials

327 Total Patients Enrolled

Abby DoctoleroStudy DirectorPear Therapeutics, Inc.

Paula WalkerStudy DirectorPear Therapeutics, Inc.

Media Library

PEAR-003A (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04325464 — N/A

Chronic Insomnia Research Study Groups: PEAR-003A

Chronic Insomnia Clinical Trial 2023: PEAR-003A Highlights & Side Effects. Trial Name: NCT04325464 — N/A

PEAR-003A (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04325464 — N/A

Chronic Insomnia Patient Testimony for trial: Trial Name: NCT04325464 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible to enroll in this clinical trial?

"1590 patients that fit the following criteria are needed for this study: They must provide electronic informed consent, be between 22-75 years old, have an ISI score of 8 or greater, have insomnia symptoms for a minimum of 3 months, sleep 6.5 hours or less per night on average, have access to a mobile device, and finally they must be residents of the United States that will remain in the country for the duration of the trial."

Answered by AI

Are people still able to sign up for this clinical trial?

"Unfortunately, this trial is not currently recruiting patients. The last update on the website clinicaltrials.gov was on September 13th, 2022. Although there are 216 other trials actively recruiting right now, this one is not seeking any more participants."

Answered by AI

Does this research involve any geriatric patients?

"This particular clinical trial is for patients that are between 22 and 75 years old. However, there are 21 other studies for people under 18 and 168 studies for those over 65."

Answered by AI

Who else is applying?

What state do they live in?

Colorado

New Hampshire

How old are they?

18 - 65

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

What site did they apply to?

Pear Therapeutics, Inc.

How many prior treatments have patients received?

Why did patients apply to this trial?

I have not tried anything for this insomnia. I have tried many different sleep medications without success.

PatientReceived no prior treatments

I have been on numerous kinds of medications that either have bad side effects or don't work. I am currently taking medicine to go to sleep and once I get to sleep, I wake up every 2 to 3 hours, and medication to keep me awake during the day. I am desperate to be able to get good, restorative sleep without having to take medication.

PatientReceived 2+ prior treatments