Insomnia Chronic
Conditions
Keywords
insomnia, CBT-I
Brief summary
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
Detailed description
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.
Interventions
DEVICEPEAR-003b PDT Intervention
The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.
DEVICEFitbit
Patients will receive a Fitbit and receive standard of care
BEHAVIORALSleep education materials
Patients will receive sleep hygiene and healthy sleep tips.
Sponsors
Mayo Clinic
National Evaluation System for health Technology Coordinating Center
Pear Therapeutics, Inc.
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* • 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Insomnia Severity | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Depressive Symptoms | From baseline to 9 weeks post-randomization | 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) |
| Change in Anxiety | From baseline to 9 weeks post-randomization | 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. |
| Change in Stress | From baseline to 9 weeks post-randomization | 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. |
| Change in Quality of Life (PCS) | From baseline to 9 weeks post-randomization | 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. |
| Change in Daytime Sleepiness | From baseline to 9 weeks post-randomization | Daytime sleepiness is measured by the Epworth Sleepiness Scale (ESS) The ESS total score ranges from 0 (not clinically significant) to 24 (clinically significant) |
| Change in Insomnia Severity | From baseline to 21 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) |
| Medication Utilization | From baseline to 9 weeks post-randomization | Medication utilization will be reported as the number of medication refills for sleep and/or psychotropic medications. |
| Change in Sleep Efficiency | From baseline to 9 weeks post-randomization | 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) |
| Change in Sleep Onset Latency | From baseline to 9 weeks post-randomization | 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. |
| Change in Health Utility Score | From baseline to 9 weeks post-randomization | 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. |
| Change in Quality of Life (MCS) | From baseline to 9 weeks post-randomization | 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. |
| Healthcare Utilization | From baseline to 9 weeks post-randomization | Healthcare utilization will be reported as the number of outpatient visits with a primary care clinician or specialty care clinician. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
PEAR-003b PDT Intervention: The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips. | 48 |
| 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.
Fitbit: Patients will receive a Fitbit and receive standard of care
Sleep education materials: Patients will receive sleep hygiene and healthy sleep tips. | 50 |
| Total | 98 |
Baseline characteristics
| Characteristic | PEAR-003b PDT Intervention | Total | Control Arm |
|---|---|---|---|
| Age, Continuous | 46.3 years STANDARD_DEVIATION 12.09 | 45.1 years STANDARD_DEVIATION 12.4 | 43.9 years STANDARD_DEVIATION 12.69 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 6 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 44 Participants | 89 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 43 Participants | 86 Participants | 43 Participants |
| Sex/Gender, Customized Female | 35 Participants | 69 Participants | 34 Participants |
| Sex/Gender, Customized Male | 13 Participants | 27 Participants | 14 Participants |
| Sex/Gender, Customized Non-binary/third gender | 0 Participants | 2 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
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
Population: Primary outcome measure was erased from study surveys and therefore not collected.
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PEAR-003b PDT Intervention | Change in Anxiety | -2.0 units on a scale |
| Control Arm | Change in Anxiety | -1.0 units on a scale |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PEAR-003b PDT Intervention | Change in Anxiety | -2.0 score on a scale |
| Control Arm | Change in Anxiety | -1.0 score on a scale |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PEAR-003b PDT Intervention | Change in Anxiety | -1.0 score on a scale |
| Control Arm | Change in Anxiety | -1.0 score on a scale |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PEAR-003b PDT Intervention | Change in Anxiety | -1.0 score on a scale |
| Control Arm | Change in Anxiety | -1.0 score on a scale |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PEAR-003b PDT Intervention | Change in Daytime Sleepiness | -2.0 score on a scale |
| Control Arm | Change in Daytime Sleepiness | 0.0 score on a scale |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PEAR-003b PDT Intervention | Change in Daytime Sleepiness | -2.0 score on a scale |
| Control Arm | Change in Daytime Sleepiness | 0.0 score on a scale |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PEAR-003b PDT Intervention | Change in Daytime Sleepiness | -1.0 score on a scale |
| Control Arm | Change in Daytime Sleepiness | 0.0 score on a scale |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PEAR-003b PDT Intervention | Change in Daytime Sleepiness | 0.0 score on a scale |
| Control Arm | Change in Daytime Sleepiness | -2.0 score on a scale |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PEAR-003b PDT Intervention | Change in Depressive Symptoms | -2.0 score on a scale |
| Control Arm | Change in Depressive Symptoms | -2.0 score on a scale |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PEAR-003b PDT Intervention | Change in Depressive Symptoms | -2.0 score on a scale |
| Control Arm | Change in Depressive Symptoms | -1.5 score on a scale |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PEAR-003b PDT Intervention | Change in Depressive Symptoms | -2.0 score on a scale |
| Control Arm | Change in Depressive Symptoms | -4.0 score on a scale |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PEAR-003b PDT Intervention | Change in Depressive Symptoms | -2.0 score on a scale |
| Control Arm | Change in Depressive Symptoms | 0.0 score on a scale |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PEAR-003b PDT Intervention | Change in Health Utility Score | 3.7 percentage change | Standard Error 2.8 |
| Control Arm | Change in Health Utility Score | 0.5 percentage change | Standard Error 2.2 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PEAR-003b PDT Intervention | Change in Health Utility Score | -3.8 percentage change | Standard Error 2.5 |
| Control Arm | Change in Health Utility Score | 2.6 percentage change | Standard Error 1.8 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PEAR-003b PDT Intervention | Change in Health Utility Score | 6.8 percentage change | Standard Error 3.1 |
| Control Arm | Change in Health Utility Score | -1.6 percentage change | Standard Error 1.5 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PEAR-003b PDT Intervention | Change in Health Utility Score | 1.7 percent change | Standard Error 1.8 |
| Control Arm | Change in Health Utility Score | -0.3 percent change | Standard Error 1.3 |
Secondary
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 61 weeks post-randomization
Population: The primary outcome measure was not asked in the study surveys and therefore not collected. As a result, this secondary outcome measure, a component of the primary outcome, cannot be calculated.
Secondary
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
Population: The primary outcome measure was not asked in the study surveys and therefore not collected. As a result, this secondary outcome measure, a component of the primary outcome, cannot be calculated.
Secondary
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
Population: The primary outcome measure was not asked in the study surveys and therefore not collected. As a result, this secondary outcome measure, a component of the primary outcome, cannot be calculated.
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PEAR-003b PDT Intervention | Change in Quality of Life (MCS) | 1.9 score on a scale |
| Control Arm | Change in Quality of Life (MCS) | 2.2 score on a scale |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PEAR-003b PDT Intervention | Change in Quality of Life (MCS) | 2.2 score on a scale |
| Control Arm | Change in Quality of Life (MCS) | 3.0 score on a scale |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PEAR-003b PDT Intervention | Change in Quality of Life (MCS) | 1.7 score on a scale |
| Control Arm | Change in Quality of Life (MCS) | 2.0 score on a scale |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PEAR-003b PDT Intervention | Change in Quality of Life (MCS) | 3.2 score on a scale |
| Control Arm | Change in Quality of Life (MCS) | 5.7 score on a scale |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PEAR-003b PDT Intervention | Change in Quality of Life (PCS) | -3.0 score on a scale |
| Control Arm | Change in Quality of Life (PCS) | -1.1 score on a scale |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PEAR-003b PDT Intervention | Change in Quality of Life (PCS) | -1.0 score on a scale |
| Control Arm | Change in Quality of Life (PCS) | -4.1 score on a scale |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PEAR-003b PDT Intervention | Change in Quality of Life (PCS) | -1.2 score on a scale |
| Control Arm | Change in Quality of Life (PCS) | -2.4 score on a scale |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PEAR-003b PDT Intervention | Change in Quality of Life (PCS) | 0.5 score on a scale |
| Control Arm | Change in Quality of Life (PCS) | -2.6 score on a scale |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PEAR-003b PDT Intervention | Change in Sleep Efficiency | 14 percentage points | Standard Deviation 21.1 |
| Control Arm | Change in Sleep Efficiency | 12.1 percentage points | Standard Deviation 11.5 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PEAR-003b PDT Intervention | Change in Sleep Efficiency | 11.6 percentage points | Standard Deviation 15.6 |
| Control Arm | Change in Sleep Efficiency | 15.8 percentage points | Standard Deviation 11.4 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PEAR-003b PDT Intervention | Change in Sleep Efficiency | 14.9 percentage points | Standard Deviation 16.4 |
| Control Arm | Change in Sleep Efficiency | 13.5 percentage points | Standard Deviation 15.8 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PEAR-003b PDT Intervention | Change in Sleep Efficiency | 17.5 percentage points | Standard Deviation 12.7 |
| Control Arm | Change in Sleep Efficiency | 13.8 percentage points | Standard Deviation 14.9 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PEAR-003b PDT Intervention | Change in Sleep Onset Latency | -0.926 hours | Standard Deviation 1.729 |
| Control Arm | Change in Sleep Onset Latency | -0.94 hours | Standard Deviation 1.636 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PEAR-003b PDT Intervention | Change in Sleep Onset Latency | 0.15 hours | Standard Deviation 2.21 |
| Control Arm | Change in Sleep Onset Latency | -0.193 hours | Standard Deviation 2.14 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PEAR-003b PDT Intervention | Change in Sleep Onset Latency | -0.513 hours | Standard Deviation 2.058 |
| Control Arm | Change in Sleep Onset Latency | -0.765 hours | Standard Deviation 1.728 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PEAR-003b PDT Intervention | Change in Sleep Onset Latency | -0.955 hours | Standard Deviation 1.35 |
| Control Arm | Change in Sleep Onset Latency | 0.184 hours | Standard Deviation 1.826 |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PEAR-003b PDT Intervention | Change in Stress | -1.0 score on a scale |
| Control Arm | Change in Stress | -3.0 score on a scale |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PEAR-003b PDT Intervention | Change in Stress | 0.0 score on a scale |
| Control Arm | Change in Stress | -1.5 score on a scale |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PEAR-003b PDT Intervention | Change in Stress | -1.0 score on a scale |
| Control Arm | Change in Stress | -0.5 score on a scale |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PEAR-003b PDT Intervention | Change in Stress | 0.0 score on a scale |
| Control Arm | Change in Stress | -1.0 score on a scale |
Secondary
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
Population: The healthcare utilization outcomes data were not collected due to broken connections between the data aggregating platform and both the participant's wearable device and electronic health record. The team did not discover this until after the participant follow-up period concluded.
Secondary
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
Population: The healthcare utilization outcomes data were not collected due to broken connections between the data aggregating platform and both the participant's wearable device and electronic health record. The team did not discover this until after the participant follow-up period concluded.
Secondary
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
Population: The healthcare utilization outcomes data were not collected due to broken connections between the data aggregating platform and both the participant's wearable device and electronic health record. The team did not discover this until after the participant follow-up period concluded.
Secondary
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
Population: The healthcare utilization outcomes data were not collected due to broken connections between the data aggregating platform and both the participant's wearable device and electronic health record. The team did not discover this until after the participant follow-up period concluded.
Secondary
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
Population: The healthcare utilization outcomes data were not collected due to broken connections between the data aggregating platform and both the participant's wearable device and electronic health record. The team did not discover this until after the participant follow-up period concluded.
Secondary
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
Population: The healthcare utilization outcomes data were not collected due to broken connections between the data aggregating platform and both the participant's wearable device and electronic health record. The team did not discover this until after the participant follow-up period concluded.
Secondary
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
Population: The healthcare utilization outcomes data were not collected due to broken connections between the data aggregating platform and both the participant's wearable device and electronic health record. The team did not discover this until after the participant follow-up period concluded.
Secondary
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
Population: The healthcare utilization outcomes data were not collected due to broken connections between the data aggregating platform and both the participant's wearable device and electronic health record. The team did not discover this until after the participant follow-up period concluded.