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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,590
- 试验地点
- 2
- 主要终点
- Change in Insomnia Severity Index (ISI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Change in Insomnia Severity Index (ISI)
时间窗: From Baseline to Day 63 (End of Treatment) and Days 243, 428, 610, 793 (Follow-up)
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)
次要结局
- Evaluate PEAR-003A Engagement Data(Baseline, Day 63, Day 243, Day 428, Day 610, Day 793)
- Evaluate PEAR-003A Adherence Data(Baseline, Day 63, Day 243, Day 428, Day 610, Day 793)
- Examine change in depression symptoms(Baseline, Day 63, Day 243, Day 428, Day 610, Day 793)
- Examine change in anxiety symptoms(Baseline, Day 63, Day 243, Day 428, Day 610, Day 793)