PEAR-003A for Sleeplessness

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Sleeplessness+1 More
PEAR-003A - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Sleeplessness
  • Insomnia Chronic

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Sleeplessness

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Baseline, Day 63, Day 243, Day 428, Day 610, Day 793

Baseline, Day 63
Describe user experience diary data
Describe user experience interviews
Describe user experience surveys
Day 793
Evaluate PEAR-003A Adherence Data
Evaluate PEAR-003A Engagement Data
Examine change in anxiety symptoms
Examine change in depression symptoms
Examine treatment responders' data
To determine change in quality of life
To determine change in work attendance and productivity
To determine if there is a change in daytime sleepiness
Day 793
Examine Insomnia Remission
Day 243
Change in Insomnia Severity Index (ISI)
Matched period
To evaluate potential changes in healthcare utilization and costs identified in claims

Trial Safety

Safety Progress

1 of 3

Other trials for Sleeplessness

Trial Design

1 Treatment Group

PEAR-003A
1 of 1
Experimental Treatment

1590 Total Participants · 1 Treatment Group

Primary Treatment: PEAR-003A · No Placebo Group · N/A

PEAR-003A
Device
Experimental Group · 1 Intervention: PEAR-003A · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, day 63, day 243, day 428, day 610, day 793

Who is running the clinical trial?

Pear Therapeutics, Inc.Lead Sponsor
5 Previous Clinical Trials
422 Total Patients Enrolled
Paula WalkerStudy DirectorPear Therapeutics, Inc.
Abby DoctoleroStudy DirectorPear Therapeutics, Inc.

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You sleep less than 6.5 hours per night.
You have access to a mobile device.
You are a resident of the United States and currently living in the United States for the duration of the trial.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 13th, 2021

Last Reviewed: October 7th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Colorado100.0%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%