NCT04325464

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

Open-label, 9-week Treatment, De-centralized Trial to Collect Real World Evidence for a Digital Therapeutic (DT) Delivering Cognitive Behavioral Therapy for Insomnia (CBT-I) for Participants With Chronic Insomnia

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,590 (actual)
• Sponsor: Pear Therapeutics, Inc. · Industry
• Sex: All
• Age: 22 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an open-access, open-label, decentralized clinical trial to collect real-world evidence for PEAR-003A, a digital therapeutic delivering CBT-I. Potential participants will answer an online prescreening questionnaire to determine eligibility. Qualifying participants will proceed to complete 6 weekly modules through their personal mobile phone or tablet in nine weeks. A series of the assessment and questionnaires will be administered at set points during the study. Participants will be asked to complete a follow-up module about 26 weeks, and at Days 243 (6-month), 428 (12-month), 610 (18-month) and 793 (24-month) after completing treatment. A subset of approximately 34 participants may be asked to partake in a optional user experience sub study. The participant will be asked to provide study feedback by either completing a five-day diary or an interview.

Conditions

• Chronic Insomnia

Interventions

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

Timeline

• Start date: 2020-02-18
• Primary completion: 2022-10-21
• Completion: 2024-10-31
• First posted: 2020-03-27
• Last updated: 2023-02-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study