Prescription Digital Therapeutic for the Treatment of Insomnia

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-20

Study Completion Date

2024-03-01

Brief Summary

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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

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Detailed Description

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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

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Insomnia Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PEAR-003b PDT Intervention

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.

Group Type EXPERIMENTAL

PEAR-003b PDT Intervention

Intervention Type DEVICE

The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.

Fitbit

Intervention Type DEVICE

Patients will receive a Fitbit and receive standard of care

Sleep education materials

Intervention Type BEHAVIORAL

Patients will receive sleep hygiene and healthy sleep tips.

Control Arm

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.

Group Type PLACEBO_COMPARATOR

Fitbit

Intervention Type DEVICE

Patients will receive a Fitbit and receive standard of care

Sleep education materials

Intervention Type BEHAVIORAL

Patients will receive sleep hygiene and healthy sleep tips.

Interventions

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PEAR-003b PDT Intervention

The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.

Intervention Type DEVICE

Fitbit

Patients will receive a Fitbit and receive standard of care

Intervention Type DEVICE

Sleep education materials

Patients will receive sleep hygiene and healthy sleep tips.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

22 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No