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A Remote, 9-week Insomnia Treatment Trial to Collect Real World Data for a Digital Therapeutic (DREAM)

Primary Purpose

Chronic Insomnia

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

PEAR-003A

About this trial

This is an interventional treatment trial for Chronic Insomnia focused on measuring Digital Therapeutic, CBT-I, Chronic Insomnia

Eligibility Criteria

22 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Provide electronic informed consent prior to any study specific assessments being performed
Between 22 and 75 years old, inclusively
Insomnia as defined by an ISI score of 8 or above
Insomnia symptoms for at least 3 months
< or = 6.5 hours of sleep per night
Access to a mobile device
Resident of the United States and currently living in the United States for the duration of the trial.

Exclusion Criteria:

Presence of an active and/or progressive physical illness (e.g., congestive-heart failure, chronic obstructive pulmonary disease, acute pain), neurological disorder (e.g., epilepsy) or neurological degenerative diseases (e.g., dementia, multiple sclerosis)
Unstable medication regimen (change to schedule or dosage within the past 3 months)
Diagnosis of a psychotic disorder or bipolar disorder or medical condition contraindicated by sleep restriction
Have family or work schedules that prevent them from having normal sleep schedules defined as bedtime between 8:00 pm and 2:00 am and/or waking times between 4:00 am and 10:00 am.
Individuals who need to be alert or cautious to avoid serious accidents in their job or daily life. Examples include: Long-haul truck drivers, Long-distance bus drivers, Air traffic controllers, Operators of heavy machinery, some assembly line jobs.
Pregnant or planning to become pregnant during the course of the trial.
Other untreated sleep disorders as self-reported by the participant (e.g., obstructive sleep apnea, periodic leg movements, parasomnias)
Participated in an investigational research study in the past 30 days

Sites / Locations

Pear Therapeutics, Inc.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PEAR-003A

Arm Description

Digital Therapeutic

Outcomes

Primary Outcome Measures

Change in Insomnia Severity Index (ISI)

Change in the Insomnia Severity Index's (ISI) total score from Baseline to End of Treatment and Follow-up. The ISI's total score ranges from 0 (not clinically significant) to 28 (clinically significant)

Secondary Outcome Measures

Evaluate PEAR-003A Engagement Data

Evaluate PEAR-003A engagement rates

Evaluate PEAR-003A Adherence Data

Evaluate PEAR-003A adherence rates

Examine change in depression symptoms

Change in the eight-item Patient Health Questionnaire (PHQ-8) scores from Baseline to End of Treatment and Follow-up. The PHQ's total score ranges from 0 (not clinically significant) to 24 (clinically significant)

Examine change in anxiety symptoms

Change in the Generalized Anxiety Disorder-7's (GAD-7) scores from Baseline to End of Treatment and Follow-up. The GAD-7's total score ranges from 0 (not clinically significant) to 21 (clinically significant)

Full Information

NCT ID

NCT04325464

First Posted

February 20, 2020

Last Updated

January 31, 2023

Sponsor

Pear Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04325464

Brief Title

A Remote, 9-week Insomnia Treatment Trial to Collect Real World Data for a Digital Therapeutic

Acronym

DREAM

Official Title

Open-label, 9-week Treatment, De-centralized Trial to Collect Real World Evidence for a Digital Therapeutic (DT) Delivering Cognitive Behavioral Therapy for Insomnia (CBT-I) for Participants With Chronic Insomnia

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

February 18, 2020 (Actual)

Primary Completion Date

October 21, 2022 (Actual)

Study Completion Date

October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pear Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of the study is to collect data in a real-world environment, for a digital therapeutic that delivers CBT-I through a decentralized clinical trial, open to participants with chronic insomnia.

Detailed Description

This is an open-access, open-label, decentralized clinical trial to collect real-world evidence for PEAR-003A, a digital therapeutic delivering CBT-I. Potential participants will answer an online prescreening questionnaire to determine eligibility. Qualifying participants will proceed to complete 6 weekly modules through their personal mobile phone or tablet in nine weeks. A series of the assessment and questionnaires will be administered at set points during the study. Participants will be asked to complete a follow-up module about 26 weeks, and at Days 243 (6-month), 428 (12-month), 610 (18-month) and 793 (24-month) after completing treatment. A subset of approximately 34 participants may be asked to partake in a optional user experience sub study. The participant will be asked to provide study feedback by either completing a five-day diary or an interview.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Insomnia

Keywords

Digital Therapeutic, CBT-I, Chronic Insomnia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1590 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PEAR-003A

Arm Type

Experimental

Arm Description

Digital Therapeutic

Intervention Type

Device

Intervention Name(s)

PEAR-003A

Intervention Description

PEAR-003A delivers CBT-I through a decentralized clinical trial open to participants with chronic insomnia

Primary Outcome Measure Information:

Title

Change in Insomnia Severity Index (ISI)

Description

Time Frame

From Baseline to Day 63 (End of Treatment) and Days 243, 428, 610, 793 (Follow-up)

Secondary Outcome Measure Information:

Title

Evaluate PEAR-003A Engagement Data

Description

Evaluate PEAR-003A engagement rates

Time Frame

Baseline, Day 63, Day 243, Day 428, Day 610, Day 793

Title

Evaluate PEAR-003A Adherence Data

Description

Evaluate PEAR-003A adherence rates

Time Frame

Baseline, Day 63, Day 243, Day 428, Day 610, Day 793

Title

Examine change in depression symptoms

Description

Time Frame

Baseline, Day 63, Day 243, Day 428, Day 610, Day 793

Title

Examine change in anxiety symptoms

Description

Time Frame

Baseline, Day 63, Day 243, Day 428, Day 610, Day 793

Other Pre-specified Outcome Measures:

Title

Examine treatment responders' data

Description

Treatment responders are those whose ISI decreased by more than 7 points. Responders ISI score will be evaluated at the end of treatment and follow-up.

Time Frame

Baseline, Day 63, Day 243, Day 428, Day 610, Day 793

Title

Examine Insomnia Remission

Description

Subjects in treatment remission are those whose ISI score is 8 or less. Subjects in treatment remission ISI scores will be evaluated at end of treatment and follow-up

Time Frame

Day 63, Day 243, Day 428, Day 610, Day 793

Title

Describe user experience surveys

Description

Summarize user experience surveys through descriptive statistics

Time Frame

Baseline, Day 63

Title

Describe user experience diary data

Description

Summarize qualitative diary data through descriptive statistics

Time Frame

Baseline, Day 63

Title

Describe user experience interviews

Description

Summarize user experience interviews through descriptive statistics

Time Frame

Baseline, Day 63

Title

To determine if there is a change in daytime sleepiness

Description

Change in Epworth Sleepiness Scale from baseline to end of treatment and follow-up. The ESS total score ranges from 0 (not clinically significant) to 24 (clinically significant)

Time Frame

Baseline, Day 63, Day 243, Day 428, Day 610, Day 793

Title

To determine change in quality of life

Description

Change in quality of life as measured in The Short Form 12 (SF-12). The SF-12 summary scores range from 0-100 with higher scores representing better self-reported health

Time Frame

Baseline, Day 63, Day 243, Day 428, Day 610, Day 793

Title

To determine change in work attendance and productivity

Description

Change in presenteeism/absenteeism work questions based on a survey. Subject answers Yes/No questions of whether continuously employed during the time period. If not, they can enter number of days employed or missed. Survey also contains a question regarding rating of productivity in %.

Time Frame

Baseline, Day 63, Day 243, Day 428, Day 610, Day 793

Title

To evaluate potential changes in healthcare utilization and costs identified in claims

Description

Change in tokenized health claims from a specified period (up to 24 months) prior to intervention and a similar period after intervention

Time Frame

Matched period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Provide electronic informed consent prior to any study specific assessments being performed Between 22 and 75 years old, inclusively Insomnia as defined by an ISI score of 8 or above Insomnia symptoms for at least 3 months < or = 6.5 hours of sleep per night Access to a mobile device Resident of the United States and currently living in the United States for the duration of the trial. Exclusion Criteria: Presence of an active and/or progressive physical illness (e.g., congestive-heart failure, chronic obstructive pulmonary disease, acute pain), neurological disorder (e.g., epilepsy) or neurological degenerative diseases (e.g., dementia, multiple sclerosis) Unstable medication regimen (change to schedule or dosage within the past 3 months) Diagnosis of a psychotic disorder or bipolar disorder or medical condition contraindicated by sleep restriction Have family or work schedules that prevent them from having normal sleep schedules defined as bedtime between 8:00 pm and 2:00 am and/or waking times between 4:00 am and 10:00 am. Individuals who need to be alert or cautious to avoid serious accidents in their job or daily life. Examples include: Long-haul truck drivers, Long-distance bus drivers, Air traffic controllers, Operators of heavy machinery, some assembly line jobs. Pregnant or planning to become pregnant during the course of the trial. Other untreated sleep disorders as self-reported by the participant (e.g., obstructive sleep apnea, periodic leg movements, parasomnias) Participated in an investigational research study in the past 30 days

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Abby Doctolero

Organizational Affiliation

Pear Therapeutics, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Pear Therapeutics, Inc.

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02109

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33682430

Citation

Thorndike FP, Berry RB, Gerwien R, Braun S, Maricich YA. Protocol for Digital Real-world Evidence trial for Adults with insomnia treated via Mobile (DREAM): an open-label trial of a prescription digital therapeutic for treating patients with chronic insomnia. J Comp Eff Res. 2021 May;10(7):569-581. doi: 10.2217/cer-2021-0004. Epub 2021 Mar 8.

Results Reference

derived

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A Remote, 9-week Insomnia Treatment Trial to Collect Real World Data for a Digital Therapeutic

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