Prescription Digital Therapeutic for the Treatment of Insomnia (SLEEP-I)

Yale University

Status: Completed

Conditions: Insomnia Chronic

Treatments: Device: PEAR-003b PDT Intervention; Device: Fitbit; Behavioral: Sleep education materials

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04909229

2000029050

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 22 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• • 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups, including a placebo group

PEAR-003b PDT Intervention

Experimental group

Description:

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:

Behavioral: Sleep education materials

Device: Fitbit

Device: PEAR-003b PDT Intervention

Control Arm

Placebo Comparator group

Description:

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:

Behavioral: Sleep education materials

Device: Fitbit