Status:
COMPLETED
Prescription Digital Therapeutic for the Treatment of Insomnia
Lead Sponsor:
Yale University
Collaborating Sponsors:
Mayo Clinic
National Evaluation System for health Technology Coordinating Center
Conditions:
Insomnia Chronic
Eligibility:
All Genders
22-64 years
Phase:
NA
Brief 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 deliverin...
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...
Eligibility Criteria
Inclusion
- • Age between 22-64 years
- English-speaking (both reading and writing in English required)
- Diagnosis of chronic insomnia
- Participant is willing and able to give consent and participate in study
- Participant has an email account or is willing to create one and a smartphone able to download the necessary applications
- Participant is willing and able to use the PDT, the Hugo data sharing platform and the syncable devices (e.g. Fitbit)
- Participant has primary care at YNHH or Mayo Clinic
Exclusion
- Pregnancy
- Shift work or family/other commitments that interfere with establishment of regular night-time sleep patterns, and if wake/sleep time is outside the ranges of 4:00h - 10:00h (wake time) and 20:00h - 02:00h (bed time)
- Absence of a reliable internet access and smartphone
- A reported diagnosis of psychosis, schizophrenia or bipolar disorder, or any medical disorders contraindicated with sleep restriction
- Current involvement in a non-medication treatment program for insomnia (participants are still eligible if they are taking traditional sleep medications)
- Those with untreated co-existing sleep conditions (e.g. sleep apnea)
- Those who have failed CBT for insomnia in the past
Key Trial Info
Start Date :
December 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04909229
Start Date
December 20 2021
End Date
March 1 2024
Last Update
July 28 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Yale-New Haven Hospital
New Haven, Connecticut, United States, 06510
2
Mayo Clinic
Rochester, Minnesota, United States, 55905