NCT04909229

Prescription Digital Therapeutic for the Treatment of Insomnia

Randomized Controlled Trial Examining Real-World Effectiveness of a Prescription Digital Therapeutic for the Treatment of Insomnia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 22 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This will be a prospective multi-center controlled trial of 100 patients conducted to assess the real-world effectiveness of a mobile-delivered, prescription digital therapeutic (PDT) device delivering Cognitive Behavioral Therapy for Insomnia using a novel patient-centered data-sharing platform with linkage to Fitbit for 61 weeks

Detailed description

This is a multi-center, randomized, controlled trial to assess the real-world effectiveness of a mobile-delivered, prescription digital therapeutic (PDT) device delivering Cognitive Behavioral Therapy for Insomnia (i.e., Somryst, herein called PEAR-003b) using a novel patient-centered data sharing platform (called Hugo), with linkage to Fitbit (Inspire 2), among 100 patients with chronic insomnia. Half of the patients with insomnia will receive the PEAR-003b digital therapeutic with linkage to the Hugo platform and Fitbit (Inspire 2) and half of the patients with insomnia will not receive the PDT but will receive a Fitbit and be enrolled in the Hugo platform. The treatment duration will be 9 weeks with a 21-, 35-, and 61-week follow-up. All patients will be evaluated at baseline, as well as prompted to complete additional assessments at weeks 9, 21, 35, and 61. The PEAR-003b intervention will deliver CBT-I via mobile devices as 6 treatment core modules over 9 weeks. Additionally, the Hugo platform will be used to collect patient-generated engagement data, healthcare utilization outcomes, and patient activity/clinical outcomes. These real-world data points and trends collected as part of this pilot investigation will help inform a future larger healthcare effectiveness and outcomes research study.

Conditions

• Insomnia Chronic

Interventions

Type	Name	Description
DEVICE	PEAR-003b PDT Intervention	The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.
DEVICE	Fitbit	Patients will receive a Fitbit and receive standard of care
BEHAVIORAL	Sleep education materials	Patients will receive sleep hygiene and healthy sleep tips.

Timeline

• Start date: 2021-12-20
• Primary completion: 2023-03-03
• Completion: 2024-03-01
• First posted: 2021-06-01
• Last updated: 2025-07-28
• Results posted: 2024-03-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study