Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| 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) |
From baseline to 9 weeks post randomization |
|
| 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) |
From baseline to 21 weeks post-randomization |
|
| 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) |
From baseline to 35 weeks post-randomization |
|
| 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) |
From baseline to 61 weeks post-randomization |
|
| 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) |
From baseline to 9 weeks post-randomization |
|
| 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) |
From baseline to 21 weeks post-randomization |
|
| 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) |
From baseline to 35 weeks post-randomization |
|
| 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) |
From baseline to 61 weeks post-randomization |
|
| 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. |
From baseline to 9 weeks post-randomization |
|
| 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. |
From baseline to 21 weeks post-randomization |
|
| 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. |
From baseline to 35 weeks post-randomization |
|
| 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. |
From baseline to 61 weeks post-randomization |
|
| 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. |
From baseline to 9 weeks post-randomization |
|
| 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. |
From baseline to 21 weeks post-randomization |
|
| 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. |
From baseline to 35 weeks post-randomization |
|
| 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. |
From baseline to 61 weeks post-randomization |
|
| Secondary |
Change Quality of Life |
Change in quality of life as measured in The Short Form 12 (SF-12). The SF-12 summary scores range from 0-100 with higher scores representing better self-reported health. |
From baseline to 9 weeks post-randomization |
|
| Secondary |
Change Quality of Life |
Change in quality of life as measured in The Short Form 12 (SF-12). The SF-12 summary scores range from 0-100 with higher scores representing better self-reported health. |
From baseline to 21 weeks post-randomization |
|
| Secondary |
Change Quality of Life |
Change in quality of life as measured in The Short Form 12 (SF-12). The SF-12 summary scores range from 0-100 with higher scores representing better self-reported health. |
From baseline to 35 weeks post-randomization |
|
| Secondary |
Change Quality of Life |
Change in quality of life as measured in The Short Form 12 (SF-12). The SF-12 summary scores range from 0-100 with higher scores representing better self-reported health. |
From baseline to 61 weeks post-randomization |
|
| 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) |
From baseline to 9 weeks post-randomization |
|
| 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) |
From baseline to 21 weeks post-randomization |
|
| 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) |
From baseline to 35 weeks post-randomization |
|
| 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) |
From baseline to 61 weeks post-randomization |
|
| Secondary |
Healthcare Utilization |
Healthcare utilization will be reported as the number of outpatient visits with a primary care clinician or specialty care clinician. |
From baseline to 9 weeks post-randomization |
|
| Secondary |
Healthcare Utilization |
Healthcare utilization will be reported as the number of outpatient visits with a primary care clinician or specialty care clinician. |
From baseline to 21 weeks post-randomization |
|
| Secondary |
Healthcare Utilization |
Healthcare utilization will be reported as the number of outpatient visits with a primary care clinician or specialty care clinician. |
From baseline to 35 weeks post-randomization |
|
| Secondary |
Healthcare Utilization |
Healthcare utilization will be reported as the number of outpatient visits with a primary care clinician or specialty care clinician. |
From baseline to 61 weeks post-randomization |
|
| Secondary |
Medication Utilization |
Medication utilization will be reported as the number of medication refills for sleep and/or psychotropic medications. |
From baseline to 9 weeks post-randomization |
|
| Secondary |
Medication Utilization |
Medication utilization will be reported as the number of medication refills for sleep and/or psychotropic medications. |
From baseline to 21 weeks post-randomization |
|
| Secondary |
Medication Utilization |
Medication utilization will be reported as the number of medication refills for sleep and/or psychotropic medications. |
From baseline to 35 weeks post-randomization |
|
| Secondary |
Medication Utilization |
Medication utilization will be reported as the number of medication refills for sleep and/or psychotropic medications. |
From baseline to 61 weeks post-randomization |
|
| 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%) |
From baseline to 9 weeks post-randomization |
|
| 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%) |
From baseline to 21 weeks post-randomization |
|
| 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%) |
From baseline to 35 weeks post-randomization |
|
| 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%) |
From baseline to 61 weeks post-randomization |
|
| Secondary |
Change in Sleep Onset Latency |
Sleep-onset latency (SOL; min), is based on the participants sleep diary and how many minutes it took the participants to fall asleep. |
From baseline to 9 weeks post-randomization |
|
| Secondary |
Change in Sleep Onset Latency |
Sleep-onset latency (SOL; min), is based on the participants sleep diary and how many minutes it took the participants to fall asleep. |
From baseline to 21 weeks post-randomization |
|
| Secondary |
Change in Sleep Onset Latency |
Sleep-onset latency (SOL; min), is based on the participants sleep diary and how many minutes it took the participants to fall asleep. |
From baseline to 35 weeks post-randomization |
|
| Secondary |
Change in Sleep Onset Latency |
Sleep-onset latency (SOL; min), is based on the participants sleep diary and how many minutes it took the participants to fall asleep. |
From baseline to 61 weeks post-randomization |
|
| Secondary |
Change in Health Utility Score |
Change in health utility score will be generated by applying the Short Form-6D algorithm to Short Form-12 responses. Utility values for SF-6D health states can fall between 0.30 and 1.0, where 1.0 represents full health and 0 represents death. |
From baseline to 9 weeks post-randomization |
|
| Secondary |
Change in Health Utility Score |
Change in health utility score will be generated by applying the Short Form-6D algorithm to Short Form-12 responses. Utility values for SF-6D health states can fall between 0.30 and 1.0, where 1.0 represents full health and 0 represents death. |
From baseline to 21 weeks post-randomization |
|
| Secondary |
Change in Health Utility Score |
Change in health utility score will be generated by applying the Short Form-6D algorithm to Short Form-12 responses. Utility values for SF-6D health states can fall between 0.30 and 1.0, where 1.0 represents full health and 0 represents death. |
From baseline to 35 weeks post-randomization |
|
| Secondary |
Change in Health Utility Score |
Change in health utility score will be generated by applying the Short Form-6D algorithm to Short Form-12 responses. Utility values for SF-6D health states can fall between 0.30 and 1.0, where 1.0 represents full health and 0 represents death. |
From baseline to 61 weeks post-randomization |
|
