Clinical trial
Prescription Digital Therapeutic for the Treatment of Insomnia
NCT04909229 · Yale University, Other · Completed
Key facts
| NCT number | NCT04909229 |
|---|---|
| Title | Prescription Digital Therapeutic for the Treatment of Insomnia |
| Official title | Randomized Controlled Trial Examining Real-World Effectiveness of a Prescription Digital Therapeutic for the Treatment of Insomnia |
| Acronym | SLEEP-I |
| Lead sponsor | Yale University, Other |
| Collaborators | Mayo Clinic National Evaluation System for health Technology Coordinating Center Pear Therapeutics, Inc. Industry |
| Status | Completed |
| Study type | Interventional |
| Conditions | Insomnia Chronic |
| Intervention type | Behavioral, Device |
| Interventions | PEAR-003b PDT Intervention, Fitbit, Sleep education materials |
| Enrollment | 100 |
| Start date | Dec 20, 2021 |
| Primary completion | Mar 3, 2023 |
| Completion | Mar 1, 2024 |
| First posted | Jun 1, 2021 |
| Last update posted | Jul 28, 2025 |
| Countries | United States |
At a glance
- 1–9 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: