Wearable Devices to Assess Effects of Central Nervous Medications on Physical Conditions in Patients With Sleep Problems

Primary outcomes

1. Change of the severity of anxiety measured by Beck Anxiety Inventory (BAI) across three points of the study

   Time frame: Assessed at the second, fourth, and twelfth weeks of the study

   The Beck Anxiety Inventory (BAI) is a 21-question multiple-choice self-report inventory that is used for measuring the severity of anxiety in adolescents and adults ages 17 and older. The questions used in this measure ask about common symptoms of anxiety that the subject has had during the past week (including the day you take it) (such as numbness and tingling, sweating not due to heat, and fear of the worst happening). The BAI contains 21 questions, each answer being scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms.

   The standardized cutoffs are:

   • 0-7: Minimal
   • 8-15: Mild
   • 16-25: Moderate
   • 26-63: Severe

2. Change of the severity of depression measured by Beck Depression Inventory (BDI) across three points of the study

   Time frame: Assessed at the second, fourth, and twelfth weeks of the study

   The Beck Depression Inventory (BDI) is a 21-question multiple-choice self-report inventory, one of the most widely used psychometric tests for measuring the severity of depression. The BDI is designed for individuals aged 13 and over, and is composed of items relating to symptoms of depression such as hopelessness and irritability, cognitions such as guilt or feelings of being punished, as well as physical symptoms such as fatigue, weight loss, and lack of interest in sex. The BDI contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms.

   The standardized cutoffs are:

   • 0-13: minimal depression
   • 14-19: mild depression
   • 20-28: moderate depression
   • 29-63: severe depression.

3. Change of the severity of daytime sleepiness measured by Epworth Sleepiness Scale (ESS) across three points of the study

   Time frame: Assessed at the second, fourth, and twelfth weeks of the study

   The ESS is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. Most people engage in those activities at least occasionally, although not necessarily every day. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'.

   In general ESS scores can be interpreted as follows:

   • 0-5 Lower Normal Daytime Sleepiness
   • 6-10 Higher Normal Daytime Sleepiness
   • 11-12 Mild Excessive Daytime Sleepiness
   • 13-15 Moderate Excessive Daytime Sleepiness
   • 16-24 Severe Excessive Daytime Sleepiness

4. Change of sleep quality measured by Pittsburgh Sleep Quality Index (PSQI) across three points of the study

   Time frame: Assessed at the second, fourth, and twelfth weeks of the study

   The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete. The PSQI measures several different aspects of sleep, offering seven component scores and one composite score. The component scores consist of subjective sleep quality, sleep latency (i.e., how long it takes to fall asleep), sleep duration, habitual sleep efficiency (i.e., the percentage of time in bed that one is asleep), sleep disturbances, use of sleeping medication, and daytime dysfunction. Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, where lower scores denote a healthier sleep quality. A final score >5 be considered as a significant sleep disturbance.

5. Change of autonomic nervous system functioning measured by Heart rate variability (HRV) across three points of the study

   Time frame: Assessed at the second, fourth, and twelfth weeks of the study

   Heart rate variability (HRV) consists of changes in the time intervals between consecutive heartbeats called interbeat intervals (IBIs). HRV indexes neurocardiac function and is generated by heart-brain interactions and dynamic non-linear autonomic nervous system processes. HRV reflects regulation of autonomic balance, blood pressure (BP), gas exchange, gut, heart, and vascular tone, which refers to the diameter of the blood vessels that regulate BP, and possibly facial muscles. HRV can be analyzed through time-domain, frequency-domain, and non-linear metrics. Time-domain indices quantify the amount of HRV observed during monitoring periods that may range from ~2 min to 24 h. Frequency-domain values calculate the absolute or relative amount of signal energy within component bands. Non-linear measurements quantify the unpredictability and complexity of a series of IBIs.