Randomized Controlled Trial Examining Real-World Effectiveness of a Prescription Digital Therapeutic for the Treatment of Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in Insomnia Severity
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• 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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: PEAR-003b PDT Intervention (Device)
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.
干预措施: Fitbit (Device)
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.
干预措施: Sleep education materials (Behavioral)
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.
干预措施: Fitbit (Device)
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.
干预措施: Sleep education materials (Behavioral)
结局指标
主要结局
Change in Insomnia Severity
时间窗: From baseline to 9 weeks post randomization
Insomnia will be measured by the Insomnia Severity Index (ISI) score. Participants rate the severity of sleep problems (e.g. problems with sleep onset, sleep maintenance, and early morning awakening), interference with daytime functioning, how noticeable the impairment is to others, distress or concern caused by the sleep problem(s), as well as satisfaction with the current sleep pattern on a 5-point Likert scale. The ISI's total score ranges from 0 (not clinically significant) to 28 (clinically significant)
次要结局
- Change in Insomnia Severity(From baseline to 61 weeks post-randomization)
- Change in Depressive Symptoms(From baseline to 61 weeks post-randomization)
- Change in Anxiety(From baseline to 61 weeks post-randomization)
- Change in Stress(From baseline to 61 weeks post-randomization)
- Change in Quality of Life (PCS)(From baseline to 61 weeks post-randomization)
- Change in Daytime Sleepiness(From baseline to 61 weeks post-randomization)
- Healthcare Utilization(From baseline to 61 weeks post-randomization)
- Medication Utilization(From baseline to 61 weeks post-randomization)
- Change in Sleep Efficiency(From baseline to 61 weeks post-randomization)
- Change in Sleep Onset Latency(From baseline to 61 weeks post-randomization)
- Change in Health Utility Score(From baseline to 61 weeks post-randomization)
- Change in Quality of Life (MCS)(From baseline to 61 weeks post-randomization)
- Change in Insomnia Severity(From baseline to 61 weeks post-randomization)
- Change in Depressive Symptoms(From baseline to 61 weeks post-randomization)
- Change in Anxiety(From baseline to 61 weeks post-randomization)
- Change in Stress(From baseline to 61 weeks post-randomization)
- Change in Quality of Life (PCS)(From baseline to 61 weeks post-randomization)
- Change in Daytime Sleepiness(From baseline to 61 weeks post-randomization)
- Healthcare Utilization(From baseline to 61 weeks post-randomization)
- Medication Utilization(From baseline to 61 weeks post-randomization)
- Change in Sleep Efficiency(From baseline to 61 weeks post-randomization)
- Change in Sleep Onset Latency(From baseline to 61 weeks post-randomization)
- Change in Health Utility Score(From baseline to 61 weeks post-randomization)
- Change in Quality of Life (MCS)(From baseline to 61 weeks post-randomization)
- Change in Quality of Life (PCS)(From baseline to 9 weeks post-randomization)
- Change in Quality of Life (PCS)(From baseline to 21 weeks post-randomization)
- Change in Insomnia Severity(From baseline to 21 weeks post-randomization)
- Change in Insomnia Severity(From baseline to 35 weeks post-randomization)
- Change in Depressive Symptoms(From baseline to 9 weeks post-randomization)
- Change in Depressive Symptoms(From baseline to 21 weeks post-randomization)
- Change in Depressive Symptoms(From baseline to 35 weeks post-randomization)
- Change in Anxiety(From baseline to 9 weeks post-randomization)
- Change in Anxiety(From baseline to 21 weeks post-randomization)
- Change in Anxiety(From baseline to 35 weeks post-randomization)
- Change in Stress(From baseline to 9 weeks post-randomization)
- Change in Stress(From baseline to 21 weeks post-randomization)
- Change in Stress(From baseline to 35 weeks post-randomization)
- Change in Quality of Life (PCS)(From baseline to 35 weeks post-randomization)
- Change in Daytime Sleepiness(From baseline to 9 weeks post-randomization)
- Change in Daytime Sleepiness(From baseline to 21 weeks post-randomization)
- Change in Daytime Sleepiness(From baseline to 35 weeks post-randomization)
- Healthcare Utilization(From baseline to 9 weeks post-randomization)
- Healthcare Utilization(From baseline to 21 weeks post-randomization)
- Healthcare Utilization(From baseline to 35 weeks post-randomization)
- Medication Utilization(From baseline to 9 weeks post-randomization)
- Medication Utilization(From baseline to 21 weeks post-randomization)
- Medication Utilization(From baseline to 35 weeks post-randomization)
- Change in Sleep Efficiency(From baseline to 9 weeks post-randomization)
- Change in Sleep Efficiency(From baseline to 21 weeks post-randomization)
- Change in Sleep Efficiency(From baseline to 35 weeks post-randomization)
- Change in Sleep Onset Latency(From baseline to 9 weeks post-randomization)
- Change in Sleep Onset Latency(From baseline to 21 weeks post-randomization)
- Change in Sleep Onset Latency(From baseline to 35 weeks post-randomization)
- Change in Health Utility Score(From baseline to 9 weeks post-randomization)
- Change in Health Utility Score(From baseline to 21 weeks post-randomization)
- Change in Health Utility Score(From baseline to 35 weeks post-randomization)
- Change in Quality of Life (MCS)(From baseline to 9 weeks post-randomization)
- Change in Quality of Life (MCS)(From baseline to 21 weeks post-randomization)
- Change in Quality of Life (MCS)(From baseline to 35 weeks post-randomization)