A Remote, 9-week Insomnia Treatment Trial to Collect Real World Data for a Digital Therapeutic

NCT04325464 | Unknown FDA Device

• 2 other identifiers: PEAR-003-101DREAM Study
• Study Type: interventional
• Target: 1,590
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to collect data in a real-world environment, for a digital therapeutic that delivers CBT-I through a decentralized clinical trial, open to participants with chronic insomnia.

Conditions

Chronic Insomnia

Keywords

Digital Therapeutic; CBT-I; Chronic Insomnia

Outcome Measures

Primary Outcomes (1)

• Change in Insomnia Severity Index (ISI)

  Change in the Insomnia Severity Index's (ISI) total score from Baseline to End of Treatment and Follow-up. The ISI's total score ranges from 0 (not clinically significant) to 28 (clinically significant)

  From Baseline to Day 63 (End of Treatment) and Days 243, 428, 610, 793 (Follow-up)

Secondary Outcomes (4)

• Evaluate PEAR-003A Engagement Data

  Baseline, Day 63, Day 243, Day 428, Day 610, Day 793

• Evaluate PEAR-003A Adherence Data

  Baseline, Day 63, Day 243, Day 428, Day 610, Day 793

• Examine change in depression symptoms

  Baseline, Day 63, Day 243, Day 428, Day 610, Day 793

• Examine change in anxiety symptoms

  Baseline, Day 63, Day 243, Day 428, Day 610, Day 793

Other Outcomes (9)

• Examine treatment responders' data

  Baseline, Day 63, Day 243, Day 428, Day 610, Day 793

• Examine Insomnia Remission

  Day 63, Day 243, Day 428, Day 610, Day 793

• Describe user experience surveys

  Baseline, Day 63

Study Arms (1)

PEAR-003A

EXPERIMENTAL

Digital Therapeutic

Device: PEAR-003A

Interventions

PEAR-003A DEVICE

PEAR-003A delivers CBT-I through a decentralized clinical trial open to participants with chronic insomnia

PEAR-003A

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide electronic informed consent prior to any study specific assessments being performed
• Between 22 and 75 years old, inclusively
• Insomnia as defined by an ISI score of 8 or above
• Insomnia symptoms for at least 3 months
• \< or = 6.5 hours of sleep per night
• Access to a mobile device
• Resident of the United States and currently living in the United States for the duration of the trial.

You may not qualify if:

• 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)
• Unstable medication regimen (change to schedule or dosage within the past 3 months)
• Diagnosis of a psychotic disorder or bipolar disorder or medical condition contraindicated by sleep restriction
• Have family or work schedules that prevent them from having normal sleep schedules defined as bedtime between 8:00 pm and 2:00 am and/or waking times between 4:00 am and 10:00 am.
• Individuals who need to be alert or cautious to avoid serious accidents in their job or daily life. Examples include: Long-haul truck drivers, Long-distance bus drivers, Air traffic controllers, Operators of heavy machinery, some assembly line jobs.
• Pregnant or planning to become pregnant during the course of the trial.
• Other untreated sleep disorders as self-reported by the participant (e.g., obstructive sleep apnea, periodic leg movements, parasomnias)
• Participated in an investigational research study in the past 30 days

Sponsors & Collaborators

• Pear Therapeutics, Inc.: lead

Study Sites (1)

Pear Therapeutics, Inc.

Boston, Massachusetts, 02109, United States

Location

Related Publications (2)

• Thorndike FP, Morin CM, Ojile J, Edington S, Gerwien R, Ong JC, Wickwire EM, Ritterband LM, Riney H. Effect of a prescription digital therapeutic for chronic insomnia on post-treatment insomnia severity, depression, and anxiety symptoms: results from the real-world DREAM study. Front Psychiatry. 2024 Sep 10;15:1450615. doi: 10.3389/fpsyt.2024.1450615. eCollection 2024.

  PMID: 39319356 DERIVED

• Thorndike FP, Berry RB, Gerwien R, Braun S, Maricich YA. Protocol for Digital Real-world Evidence trial for Adults with insomnia treated via Mobile (DREAM): an open-label trial of a prescription digital therapeutic for treating patients with chronic insomnia. J Comp Eff Res. 2021 May;10(7):569-581. doi: 10.2217/cer-2021-0004. Epub 2021 Mar 8.

  PMID: 33682430 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Abby Doctolero

  Pear Therapeutics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: March 27, 2020
• Study Start: February 18, 2020
• Primary Completion: October 21, 2022
• Study Completion: October 31, 2024
• Last Updated: February 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)