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

Pear Therapeutics

Status: Active, not recruiting

Conditions: Chronic Insomnia

Treatments: Device: PEAR-003A

Study type: Interventional

Funder types: Industry

Identifiers

NCT04325464

PEAR-003-101

DREAM Study (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,590 patients

Sex: All

Ages: 22 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. 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)
2. Unstable medication regimen (change to schedule or dosage within the past 3 months)
3. Diagnosis of a psychotic disorder or bipolar disorder or medical condition contraindicated by sleep restriction
4. 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.
5. 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.
6. Pregnant or planning to become pregnant during the course of the trial.
7. Other untreated sleep disorders as self-reported by the participant (e.g., obstructive sleep apnea, periodic leg movements, parasomnias)
8. Participated in an investigational research study in the past 30 days

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,590 participants in 1 patient group

PEAR-003A

Experimental group

Description:

Digital Therapeutic

Treatment:

Device: PEAR-003A