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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.
Patients will receive a Fitbit and receive standard of care
Patients will receive sleep hygiene and healthy sleep tips.
Yale-New Haven Hospital
New Haven, Connecticut, United States
Mayo Clinic
Rochester, Minnesota, United States
Change in Insomnia Severity
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)
Time frame: From baseline to 9 weeks post randomization
Change in Insomnia Severity
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)
Time frame: From baseline to 21 weeks post-randomization
Change in Insomnia Severity
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)
Time frame: From baseline to 35 weeks post-randomization
Change in Insomnia Severity
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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: From baseline to 61 weeks post-randomization
Change in Depressive Symptoms
Depressive symptoms will be measured by the Patient Health Questionnaire (PHQ-8. The PHQ-8 is an 8 item 0 to 3 scale questionnaire. Total score ranges from 0 (not clinically significant) to 24 (clinically significant)
Time frame: From baseline to 9 weeks post-randomization
Change in Depressive Symptoms
Depressive symptoms will be measured by the Patient Health Questionnaire (PHQ-8. The PHQ-8 is an 8 item 0 to 3 scale questionnaire. Total score ranges from 0 (not clinically significant) to 24 (clinically significant)
Time frame: From baseline to 21 weeks post-randomization
Change in Depressive Symptoms
Depressive symptoms will be measured by the Patient Health Questionnaire (PHQ-8. The PHQ-8 is an 8 item 0 to 3 scale questionnaire. Total score ranges from 0 (not clinically significant) to 24 (clinically significant)
Time frame: From baseline to 35 weeks post-randomization
Change in Depressive Symptoms
Depressive symptoms will be measured by the Patient Health Questionnaire (PHQ-8. The PHQ-8 is an 8 item 0 to 3 scale questionnaire. Total score ranges from 0 (not clinically significant) to 24 (clinically significant)
Time frame: From baseline to 61 weeks post-randomization
Change in Anxiety
The General Anxiety Disorder-7 (GAD-7) is a widely used diagnostic self-report scale that screens, diagnoses, and assesses the severity of anxiety disorder. The GAD-7 is a 7-item 0 to 3 (0 = Not at all, 3 = Nearly every day) scale that measures the degree of severity of anxiety over the last 2 weeks with a total score ranging from 0 to 21, with a higher score indicating a more severe anxiety.
Time frame: From baseline to 9 weeks post-randomization
Change in Anxiety
The General Anxiety Disorder-7 (GAD-7) is a widely used diagnostic self-report scale that screens, diagnoses, and assesses the severity of anxiety disorder. The GAD-7 is a 7-item 0 to 3 (0 = Not at all, 3 = Nearly every day) scale that measures the degree of severity of anxiety over the last 2 weeks with a total score ranging from 0 to 21, with a higher score indicating a more severe anxiety.
Time frame: From baseline to 21 weeks post-randomization
Change in Anxiety
The General Anxiety Disorder-7 (GAD-7) is a widely used diagnostic self-report scale that screens, diagnoses, and assesses the severity of anxiety disorder. The GAD-7 is a 7-item 0 to 3 (0 = Not at all, 3 = Nearly every day) scale that measures the degree of severity of anxiety over the last 2 weeks with a total score ranging from 0 to 21, with a higher score indicating a more severe anxiety.
Time frame: From baseline to 35 weeks post-randomization
Change in Anxiety
The General Anxiety Disorder-7 (GAD-7) is a widely used diagnostic self-report scale that screens, diagnoses, and assesses the severity of anxiety disorder. The GAD-7 is a 7-item 0 to 3 (0 = Not at all, 3 = Nearly every day) scale that measures the degree of severity of anxiety over the last 2 weeks with a total score ranging from 0 to 21, with a higher score indicating a more severe anxiety.
Time frame: From baseline to 61 weeks post-randomization
Change in Stress
The Perceived Stress Scale (PSS) is a widely used self-reported 10-item questionnaire that assesses how stressful participants believe their life is. Scores range from 0 - 40 with higher scores pointing to more perceived stress.
Time frame: From baseline to 9 weeks post-randomization
Change in Stress
The Perceived Stress Scale (PSS) is a widely used self-reported 10-item questionnaire that assesses how stressful participants believe their life is. Scores range from 0 - 40 with higher scores pointing to more perceived stress.
Time frame: From baseline to 21 weeks post-randomization
Change in Stress
The Perceived Stress Scale (PSS) is a widely used self-reported 10-item questionnaire that assesses how stressful participants believe their life is. Scores range from 0 - 40 with higher scores pointing to more perceived stress.
Time frame: From baseline to 35 weeks post-randomization
Change in Stress
The Perceived Stress Scale (PSS) is a widely used self-reported 10-item questionnaire that assesses how stressful participants believe their life is. Scores range from 0 - 40 with higher scores pointing to more perceived stress.
Time frame: From baseline to 61 weeks post-randomization
Change in Quality of Life (PCS)
Change in quality of life as measured in the Short Form 12 (SF-12). The physical health component (PCS) score ranges from 0-100 with higher scores representing better self-reported physical health.
Time frame: From baseline to 9 weeks post-randomization
Change in Quality of Life (PCS)
Change in quality of life as measured in the Short Form 12 (SF-12). The physical health component (PCS) score ranges from 0-100 with higher scores representing better self-reported physical health.
Time frame: From baseline to 21 weeks post-randomization
Change in Quality of Life (PCS)
Change in quality of life as measured in the Short Form 12 (SF-12). The physical health component (PCS) score ranges from 0-100 with higher scores representing better self-reported physical health.
Time frame: From baseline to 35 weeks post-randomization
Change in Quality of Life (PCS)
Change in quality of life as measured in the Short Form 12 (SF-12). The physical health component (PCS) score ranges from 0-100 with higher scores representing better self-reported physical health.
Time frame: From baseline to 61 weeks post-randomization
Change in Daytime Sleepiness
Daytime sleepiness is measured by the Epworth Sleepiness Scale (ESS) The ESS total score ranges from 0 (not clinically significant) to 24 (clinically significant)
Time frame: From baseline to 9 weeks post-randomization
Change in Daytime Sleepiness
Daytime sleepiness is measured by the Epworth Sleepiness Scale (ESS) The ESS total score ranges from 0 (not clinically significant) to 24 (clinically significant)
Time frame: From baseline to 21 weeks post-randomization
Change in Daytime Sleepiness
Daytime sleepiness is measured by the Epworth Sleepiness Scale (ESS) The ESS total score ranges from 0 (not clinically significant) to 24 (clinically significant)
Time frame: From baseline to 35 weeks post-randomization
Change in Daytime Sleepiness
Daytime sleepiness is measured by the Epworth Sleepiness Scale (ESS) The ESS total score ranges from 0 (not clinically significant) to 24 (clinically significant)
Time frame: From baseline to 61 weeks post-randomization
Healthcare Utilization
Healthcare utilization will be reported as the number of outpatient visits with a primary care clinician or specialty care clinician.
Time frame: From baseline to 9 weeks post-randomization
Healthcare Utilization
Healthcare utilization will be reported as the number of outpatient visits with a primary care clinician or specialty care clinician.
Time frame: From baseline to 21 weeks post-randomization
Healthcare Utilization
Healthcare utilization will be reported as the number of outpatient visits with a primary care clinician or specialty care clinician.
Time frame: From baseline to 35 weeks post-randomization
Healthcare Utilization
Healthcare utilization will be reported as the number of outpatient visits with a primary care clinician or specialty care clinician.
Time frame: From baseline to 61 weeks post-randomization
Medication Utilization
Medication utilization will be reported as the number of medication refills for sleep and/or psychotropic medications.
Time frame: From baseline to 9 weeks post-randomization
Medication Utilization
Medication utilization will be reported as the number of medication refills for sleep and/or psychotropic medications.
Time frame: From baseline to 21 weeks post-randomization
Medication Utilization
Medication utilization will be reported as the number of medication refills for sleep and/or psychotropic medications.
Time frame: From baseline to 35 weeks post-randomization
Medication Utilization
Medication utilization will be reported as the number of medication refills for sleep and/or psychotropic medications.
Time frame: From baseline to 61 weeks post-randomization
Change in Sleep Efficiency
Change in sleep efficiency, calculated as time spent sleeping divided by time spent in bed. This data is acquired from sleep diaries filled out by patient. (range 0-100 percentage points)
Time frame: From baseline to 9 weeks post-randomization
Change in Sleep Efficiency
Change in sleep efficiency, calculated as time spent sleeping divided by time spent in bed. This data is acquired from sleep diaries filled out by patient. (range 0-100 percentage points)
Time frame: From baseline to 21 weeks post-randomization
Change in Sleep Efficiency
Change in sleep efficiency, calculated as time spent sleeping divided by time spent in bed. This data is acquired from sleep diaries filled out by patient. (range 0-100 percentage points)
Time frame: From baseline to 35 weeks post-randomization
Change in Sleep Efficiency
Change in sleep efficiency, calculated as time spent sleeping divided by time spent in bed. This data is acquired from sleep diaries filled out by patient. (range 0-100 percentage points)
Time frame: From baseline to 61 weeks post-randomization
Change in Sleep Onset Latency
Change in sleep-onset latency (SOL; hour), is based on the participants sleep diary and how many hours it took the participants to fall asleep.
Time frame: From baseline to 9 weeks post-randomization
Change in Sleep Onset Latency
Change in sleep-onset latency (SOL; hour), is based on the participants sleep diary and how many hours it took the participants to fall asleep.
Time frame: From baseline to 21 weeks post-randomization
Change in Sleep Onset Latency
Change in sleep-onset latency (SOL; hour), is based on the participants sleep diary and how many hours it took the participants to fall asleep.
Time frame: From baseline to 35 weeks post-randomization
Change in Sleep Onset Latency
Change in sleep-onset latency (SOL; hour), is based on the participants sleep diary and how many hours it took the participants to fall asleep.
Time frame: From baseline to 61 weeks post-randomization
Change in Health Utility Score
The Short Form 6 dimensions (SF-6D) is a health-related quality-of-life classification system that was developed from the SF-36 health survey (SF-36) and SF-12 health survey (SF-12). In this study, a scoring method was applied that focuses on seven of the health domains covered by the SF-12: Physical Functioning, Role Limitation (combined Physical and Emotional), Social Functioning, Bodily Pain, Mental Health, and Vitality- to create a single index of health. The resulting SF-6D is scored from 0.0 (worst measured health state) to 1.0 (best measured health state), with the difference being calculated to determine the change in health utility score for each arm in each time period. Data presented here is the percent change in score from baseline to 9 weeks post-randomization.
Time frame: From baseline to 9 weeks post-randomization
Change in Health Utility Score
The Short Form 6 dimensions (SF-6D) is a health-related quality-of-life classification system that was developed from the SF-36 health survey (SF-36) and SF-12 health survey (SF-12). In this study, a scoring method was applied that focuses on seven of the health domains covered by the SF-12: Physical Functioning, Role Limitation (combined Physical and Emotional), Social Functioning, Bodily Pain, Mental Health, and Vitality- to create a single index of health. The resulting SF-6D is scored from 0.0 (worst measured health state) to 1.0 (best measured health state), with the difference being calculated to determine the change in health utility score for each arm in each time period. Data presented here is the percent change in score from baseline to 21 weeks post-randomization.
Time frame: From baseline to 21 weeks post-randomization
Change in Health Utility Score
The Short Form 6 dimensions (SF-6D) is a health-related quality-of-life classification system that was developed from the SF-36 health survey (SF-36) and SF-12 health survey (SF-12). In this study, a scoring method was applied that focuses on seven of the health domains covered by the SF-12: Physical Functioning, Role Limitation (combined Physical and Emotional), Social Functioning, Bodily Pain, Mental Health, and Vitality- to create a single index of health. The resulting SF-6D is scored from 0.0 (worst measured health state) to 1.0 (best measured health state), with the difference being calculated to determine the change in health utility score for each arm in each time period. Data presented here is the percent change in score from baseline to 35 weeks post-randomization.
Time frame: From baseline to 35 weeks post-randomization
Change in Health Utility Score
The Short Form 6 dimensions (SF-6D) is a health-related quality-of-life classification system that was developed from the SF-36 health survey (SF-36) and SF-12 health survey (SF-12). In this study, a scoring method was applied that focuses on seven of the health domains covered by the SF-12: Physical Functioning, Role Limitation (combined Physical and Emotional), Social Functioning, Bodily Pain, Mental Health, and Vitality- to create a single index of health. The resulting SF-6D is scored from 0.0 (worst measured health state) to 1.0 (best measured health state), with the difference being calculated to determine the change in health utility score for each arm in each time period. Data presented here is the percent change in score from baseline to 61 weeks post-randomization.
Time frame: From baseline to 61 weeks post-randomization
Change in Quality of Life (MCS)
Change in quality of life as measured in the Short Form 12 (SF-12). The mental health component (MCS) score ranges from 0-100 with higher scores representing better self-reported mental health.
Time frame: From baseline to 9 weeks post-randomization
Change in Quality of Life (MCS)
Change in quality of life as measured in the Short Form 12 (SF-12). The mental health component (MCS) score ranges from 0-100 with higher scores representing better self-reported mental health.
Time frame: From baseline to 21 weeks post-randomization
Change in Quality of Life (MCS)
Change in quality of life as measured in the Short Form 12 (SF-12). The mental health component (MCS) score ranges from 0-100 with higher scores representing better self-reported mental health.
Time frame: From baseline to 35 weeks post-randomization
Change in Quality of Life (MCS)
Change in quality of life as measured in the Short Form 12 (SF-12). The mental health component (MCS) score ranges from 0-100 with higher scores representing better self-reported mental health.
Time frame: From baseline to 61 weeks post-randomization