Prescription Digital Therapeutic for the Treatment of Insomnia
Key facts
- Who runs it
- Yale University
- Where
- New Haven and Rochester, United StatesSee the 2 sites
- Trial code
- Status
- Completed
- People taking part
- 100 people enrolled
- Started
- 20 Dec 2021
- Ended
- 1 Mar 2024
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- PEAR-003b PDT Intervention
- Fitbit
- Sleep education materials
- Record updated
- 28 July 2025
Who can take part
- Age
- 22 years to 64 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- • 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
Who cannot take part
- Current involvement in a non-medication treatment program for insomnia (participants are still eligible if they are taking traditional sleep medications)
- A reported diagnosis of psychosis, schizophrenia or bipolar disorder, or any medical disorders contraindicated with sleep restriction
- Those with untreated co-existing sleep conditions (e.g. sleep apnea)
- 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
- Those who have failed CBT for insomnia in the past
Where in United States
- Yale New Haven HospitalNew Haven, United StatesNo longer taking part
- Mayo ClinicRochester, United StatesNo longer taking part
About the trial
What the trial wants to find out
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
The 2 groups in the trial
- PEAR-003b PDT InterventionTreatment being tested
Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
Treatment: PEAR-003b PDT Intervention, Fitbit, and Sleep education materials
- Control ArmPlacebo, for comparison
Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
Treatment: Fitbit and Sleep education materials
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Randomized Controlled Trial Examining Real-World Effectiveness of a Prescription Digital Therapeutic for the Treatment of Insomnia
- Record updated
- 28 July 2025