Status:
UNKNOWN
A Remote, 9-week Insomnia Treatment Trial to Collect Real World Data for a Digital Therapeutic
Lead Sponsor:
Pear Therapeutics, Inc.
Conditions:
Chronic Insomnia
Eligibility:
All Genders
22-75 years
Phase:
NA
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 insomni...
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 pre...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2024
Estimated Enrollment :
1590 Patients enrolled
Trial Details
Trial ID
NCT04325464
Start Date
February 18 2020
End Date
October 31 2024
Last Update
February 1 2023
Active Locations (1)
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1
Pear Therapeutics, Inc.
Boston, Massachusetts, United States, 02109