Hempzorb81 – Sleep Analysis

Technical Memo

TO: MATT SMITH-MED7, LLC

FROM: SHAUNNA K. BURBIDGE, PHD

PROJECT: STATISTICAL ANALYSIS OF FITBIT DATA AND HEMPZORB 81 (MED7) BY DOSAGE

DATE: JANUARY 28, 2021

1.0 Summary Statistics

Before a full statistical panel could be run and evaluated, a baseline evaluation was established. Subjects in this study received 0ml (placebo), 3ml, or 4ml of Hempzorb81 daily during the 90-day study period. Tables 1-3 below show the summary statistics for the Med? and placebo groups.

Table 1. Summary Statistics-Placebo Group

Table 2. Summary Statistics-Med 7 (3ml)

Table 3. Summary Statistics-Med 7 (4ml)

2.0 Statistical Analysis

This section utilizes an analysis of variance (ANOVA) and mean comparisons (paired sampled and independent samples t-test) methods to evaluate the impact that the Hempzorb81 product has on study participant health outcomes. Outcomes analyzed include oxygen saturation, calories burned, sleep phases and resting heart rate.

Oxygen Saturation

Table 4 shows the distribution of change in oxygen saturation over the 90-day study period for each of the three dosage groups.

Table 4. Oxygen Saturation over Study Period: by dose

A paired samples t-test was employed to identify any significant changes in oxygen saturation over the course of the study (90 days). The analysis found that there was no significant change in oxygen saturation among the placebo group during the study period. However, participants receiving 3ml saw significant increases in oxygen saturation from day zero to 45 and day 45 to 90. Additionally, participants receiving a daily 4ml dose saw significant increases in oxygen saturation from day zero to 45 and day zero to day 90.

Table 5. Paired Samples t-Test: Oxygen Saturation 0-90 days

Table 6 shows the average change in daily calorie burn over the 90-day study period for each of the three dosage groups.

Table 6. Daily Calories Burned over Study Period: by dose

A paired samples t-test was employed to identify any significant changes in calorie burn over the course of the study (90 days). The analysis found no significant change in calorie burn among the placebo group during the study period. However, participants receiving 3ml saw a significant increase in calorie burn from day zero to 45 and day zero to 90. Additionally, participants receiving a daily 4ml dose saw significant increases in calorie burn from day zero to 45.

Table 7.  Paired Samples t-Test: Daily Calories Burned 0-90 days

Sleep

Fitbit estimates users' sleep stages using a combination of movement and heart-rate patterns. When the user has not moved for about an hour, the tracker or watch assumes that they are asleep. Additional data-such as the length of time that movements are indicative of sleep behavior (such as rolling over, etc.)-help confirm that a user is asleep. While sleeping, the device tracks the beat-to-beat changes in the user's heart rate, known as heart rate variability (HRV), which fluctuate as individuals transition between light sleep, deep sleep, and REM sleep stages. When the device is synced in the morning, movement and heart rate patterns from the previous night are used to estimate sleep cycles.¹

¹ "What should I know about Fitbit sleep stages". Accessed 1/25/21 at www.help.fitbit.com

Table 8 below shows the average number of minutes spent in deep sleep (per night). The Placebo group saw a reduction in deep sleep minutes, while 3ml and 4ml groups saw an increase in deep sleep minutes (primarily from baseline to day 45).

Table 8. Deep Sleep (minutes per night) over Study Period: by dose

A paired samples t-test was employed to identify any significant changes in average nightly deep sleep over the course of the study (90 days). The analysis found no significant change in deep sleep among the placebo and the 4ml dose groups during the study period (Table 9). The group receiving a 3ml dose per day saw a significant increase in deep sleep minutes from day zero to day 45 (approx. 28 minutes) and from day zero to day 90 (approx. 51 minutes total).

Table 9. Paired Samples t-Test: Deep Sleep (minutes per night) 0-90 days

² "What does each sleep stage mean?'' Accessed 1/25/21 at www.help.fitbit.com

The first phase of REM sleep occurs after an initial stage of deep sleep. REM sleep cycles are typically longer during sleep cycles occurring in the second half of the night. During this final stage of sleep, the brain becomes more active. Dreams mainly occur during REM sleep, and the eyes move quickly in different directions. Heart rate increases and breathing becomes more irregular. In principle, muscles below the neck are inactive to avoid acting out dreams. REM sleep has been shown to play an important role in mood regulation, learning, and memory as your brain processes and consolidates information from the previous day so that it can be stored in your long-term memory.

Table 10 below shows the average number of minutes spent in REM sleep (per night). The Placebo group saw no notable change in REM sleep minutes, while 3ml and 4ml groups saw an increase in REM sleep minutes (primarily from baseline to day 45).

Table 10. REM Sleep (minutes per night) over Study Period: by dose

A paired samples t-test was employed to identify any significant changes in average nightly REM sleep over the course of the study (90 days). The analysis found no significant change in REM sleep among the placebo group during the study period (Table 11). The group receiving a 3ml dose per day saw a significant increase in REM sleep minutes from day zero to day 45 (approx. 14 minutes) and from day zero to day 90 (approx. 9 minutes total). The group receiving 4ml per day saw a marginally significant increase in REM sleep minutes from day zero to day 45 (approx. 3 minutes).

Table 11. Paired Samples t-Test: REM Sleep (minutes per night) 0-90 days

Studies have shown a typical adult could wake up briefly between 10-30 times per night.³ Each Fitbit measures minutes of awake time using the metrics described previously. As sleep health improves, the number of minutes awake will decrease. Table 12 shows the distribution of change in Systolic BP over the 90-day study period for each of the dosage groups.

Table 12. Awake (minutes per night) over Study Period: by dose

A paired samples t-test was employed to identify any significant changes in average nightly awake minutes over the course of the study (90 days). The analysis found significant changes in awake minutes among all groups during the study period (Table 13). The Placebo group had a significant increase in the average number of awake minutes from day zero to day 45 (approximately 2 minutes) and day zero to day 90 (approximately 2 ½ minutes). The group receiving a 3ml dose per day saw a significant decrease in awake minutes from day zero to day 45 (approximately 12.5 minutes), from day 45 to day 90 (approximately 3 ½ minutes), and from day zero to day 90 (approximately 16 minutes total). The group receiving 4ml per day saw a significant decrease in awake minutes from day zero to day 45 (5.4 minutes), from day 45 to day 90 (2 minutes), and day zero to day 90 (7.5 minutes).

Table 13. Paired Samples t-Test: Awake (minutes per night) 0-90 days

³ "Measuring Sleep Efficiency: What should the denominator be?" Journal of Clinical Sleep Medicine. V.8(5). Pp 597-619.

Fitbit calculates your resting heart rate by measuring your heart rate when it detects sleep, and by measuring it throughout the day while you are awake but inactive (no steps detected).⁴

Table 14. Resting Heart Rate over Study Period: by dose

A paired samples t-test was employed to identify any significant changes in average resting heart rate over the course of the study (90 days). The analysis found significant changes in average resting heart rate among the experimental groups during the study period (Table 15). The Placebo group saw no significant changes in the average resting heart rate during the study period. The group receiving a 3ml dose per day saw a significant decrease in resting heart rate from day zero to day 45 (approximately 3 beats per minute) and from day zero to day 90 (approximately 4 beats per minute). The group receiving 4ml per day saw a significant decrease in resting heart rate from day zero to day 45 (approximately 3 ½ beats per minute) and day zero to day 90 (4 beats per minute).

Table 15. Table. Samples t-Test: Awake (minutes per night) 0-90 days

Regression Analysis

To conclude this analysis, a generalized least squares regression analysis was employed to identify the impact of Hempzorb81 dose on health metric outcomes. As shown below, each 1ml increase in daily med? dose resulted in significant changes to key health metrics. Each 1 ml increase in Hempzorb81 resulted in a 0.37 percent increase in oxygen saturation. Additionally, each 1 ml increase in dose resulted in a 0.4 minute decrease in awake minutes per night, and a 0.3 beats per minute decrease in resting heart rate.

⁴ "How does Fitbit detect resting heart rate?". Accessed 1/28/21 at https://community.fitbit.com

Table 16. Least Squares Regression Health Metrics and Hempzorb81 dose