A Novel Wearable Device to Improve Sleep Quality
Phase: PHASE2
Conditions: Insomnia
Sponsor: University of Utah

1 
 
 
 
Study Protocol 
Date: 7/20/2023 
IRB Approval date: 
NCT05952297 
 
 
 
 
 
A randomized pilot study of a wearable device using variable complex weak magnetic fields (VCMFs) 
among participant with poor sleep quality 
Daniel J. Anderson1, Wendy M. Troxel2, Joshua Landvatter,1 and Kelly Glazer Baron1 
1 Department of Family and Preventive Medicine, University of Utah, Salt Lake City, UT 
2 Rand Corporation, Santa Monica, CA 
Ver 7/20/2023 
 
 
 
 
 
 
 

2 
 
 
INTRODUCTION 
  
Poor sleep quality is a prevalent and global health problem. Roughly one-third of the world’s 
population reports insufficient sleep duration and as much 70% report poor quality or non-restorative 
sleep1 which can have cascading impacts on an individual’s health and wellbeing, including increased risk 
for cardiovascular morbidity and mortality, depression, and accidents.2-4 Beyond these individual health 
consequences, there are also substantial societal implications of poor sleep quality. Insomnia is associated 
with reduced productivity in the workplace due to absenteeism and presenteeism, resulting in the loss of 
an average of 44–54 working days per year.5 A recent RAND report estimated the economic losses 
associated with insomnia in several of the world’s largest economies, including an estimated $207.5 
billion dollar loss annually.6 
Given the profound consequences to public health and the economy, it is important to identify 
novel and scalable treatment options to aid the millions of individuals worldwide experiencing poor sleep 
quality. Importantly, the front-line treatment for insomnia is cognitive-behavioral therapy for insomnia.7 
However, this treatment remains underutilized due to a combination of factors, including a lack of 
specialty trained providers and lack of time and resources by both providers and patients.8 Furthermore, 
the typical course of behavioral treatment for insomnia is 6 to 8 sessions, which may be a time burden for 
many patients, especially for in-person treatment. Moreover, from a prevention perspective, there is an 
acute need to identify safe, effective, and non-invasive treatments to improve sleep quality, in those 
experiencing poor sleep quality though not necessarily meeting diagnostic criteria for clinical insomnia. 
This perspective is also consistent with current recommendations to consider sleep health on a continuum, 
as opposed to discrete clinical disorders only, and to promote sleep health across the continuum.9  
Recognizing this need, the current study investigates a novel device (Evolv28) designed to 
improve sleep through the application of variable weak magnetic frequencies. Evolv28 is a wearable sleep 
wellness device that contains coils that emits variable complex weak magnetic fields (VCMFs) through a 
neckband. The device is classified as a low-risk wellness device that does not require FDA approval.  

3 
 
 
Variable weak magnetic frequencies are proposed to interact with neural activity by subtly 
altering the brain's electromagnetic environment. Results of a pilot study testing Evolv28 suggest that 
device users may experience reductions in perceived stress and anxiety. Given strong associations 
between stress, anxiety, and poor sleep quality,10 the application of variable weak magnetic fields may 
also have benefits for sleep quality.  Preliminary studies have indicated that these frequencies can 
influence brainwave patterns associated with different sleep stages, suggesting their potential to enhance 
the restorative aspects of sleep.11-13 By targeting specific frequencies, it may be possible to facilitate 
transitions between sleep stages, potentially helping to consolidate sleep (i.e., improve sleep efficiency) 
and improve sleep quality. 
The goal of the current study was to conduct a randomized pilot study to evaluate the efficacy of 
the Evolv28 device for improving sleep quality among individuals reporting poor sleep quality. If 
successful, this intervention could represent a novel and scalable solution to the widespread global 
problem of poor sleep quality and its downstream consequences. 
 
 
METHOD 
Study Design 
The study was a randomized, double blinded, placebo-controlled trial with 4-week intervention followed 
by a two-month open label follow-up period. This study was approved by the University of Utah 
Institutional Review Board (IRB_00165943) and registered on clinicaltrials.gov 
(https://clinicaltrials.gov/study/NCT05952297). 
 
Participants 
Participants were recruited from the United States via social media advertising and the University 
of Utah research study locator portal. Inclusion criteria included the following: age 18-65, read and write 
in English, smartphone user and reporting moderate to severe insomnia symptoms, defined as an 

4 
 
 
Insomnia Severity Index score of >15. Participants were excluded if they had diagnosed sleep disorders 
other than insomnia (e.g., sleep apnea or restless legs syndrome) or were currently receiving additional 
treatment for insomnia (e.g., hypnotic medication, cognitive behavioral therapy, etc.). Further exclusion 
criteria include a history of serious mental health conditions (e.g., Patient Health Questionnaire 8 score of 
>15, psychosis, Bipolar I or the use of antipsychotic or mood stabilizing drugs), serious physical 
conditions (e.g., current cancer treatment, neurological illness), drug use (as defined by >14 alcoholic 
beverages per week, the use of cannabis >3 times in the past month, any use of illicit street drugs), 
caffeine intake of >400mg per day, overnight work more than once a month, frequent moderate to severe 
migraine attacks or headaches, pregnancy, and traveling across time zones >3 times throughout the study 
period. 
Procedure 
All study procedures were performed remotely. Interested participants completed a screening 
survey, then if eligible, a study coordinator contacted the participant via email to review study 
information and schedule a time to complete informed consent. Upon completion of informed consent, 
study materials were sent to the participant that consisted of the Evolv28 device (inactive), a Fitbit and 
device instructions. Upon receipt of the study materials, participants completed an instructional meeting 
with study staff, where they reviewed baseline procedures and Fitbit setup. Participants then completed 
online surveys, 7 days of daily electronic sleep diary surveys (SurveySignal) and wore the Fitbit for 7 
days. 
After participants completed their baseline week, a staff member, who was not associated with 
the study, determined each participant’s group assignment and then sent that participant’s device serial 
number to programmers. Participants were randomized 1:1 between intervention and control groups. The 
randomization table was generated using a random number table stratified by gender using permuted 
blocks of 4 to 6 participants. Study staff and participants were both blinded to treatment group 
assignment. To begin the 4-week trial period, the study coordinator met with each participant to ensure 
the device was activated and confirmed the participant’s understanding of how to use it. The intervention 

5 
 
 
group received the active program, and the control group received an inactive program. In both 
conditions, the device and application appeared to be active. Participants were asked to wear the device 
for at least 3 hours per day. If any technical issues occurred, the intervention time was extended to allow 
for at least four weeks of use before the post-intervention assessment. Participant adherence to the Fitbit 
and Evolv28 were monitored by the study statistician throughout the trial and reminders were sent to 
participants who were non-adherent in wearing either device for more than 2 days. 
For the follow-up assessment, participants wore the Fitbit again for 7 days and completed 
electronic sleep diaries for 7 days. Upon completion of the 4-week trial, participants completed a set of 
follow-up surveys to assess changes in sleep and mood. After the post-trial assessment, all Evolv28 were 
transitioned to run the active treatment program between week 4 and 3 months. At the end of 3 months, 
participants completed online questionnaires. Participants were compensated with $100 via an 
Amazon.com gift card and kept the study Fitbit and Evolv28 device. 
 
Measures 
Demographics: Participants filled out a brief demographic measure that contained questions on age, sex, 
gender, race/ethnicity, marital status, education level, household income level, and employment status.  
 
Insomnia Severity Index (ISI): The ISI is a widely used tool that assesses the severity of insomnia.14 It 
consists of questions that evaluate various aspects of insomnia, including difficulty sleeping, staying 
asleep, waking up too early, and the impact of these on daily functioning. Each question is scored 0-4 and 
summed, allowing for a total range of 0 to 28. Higher scores indicate a greater severity of insomnia, with 
15-21 interpreted as moderate insomnia and 22-28 interpreted as severe insomnia. 
 
Sleep Disturbance and Sleep-Related Impairment: Participants completed PROMIS sleep disturbance and 
sleep-related impairment,15 which are both 8-question adaptive measures that assess the degree to which 
participants have difficulty sleeping and the degree to which it impacts their lives, respectively. Raw 

6 
 
 
scores are converted to a standardized t score that has a mean of 50 and SD of 10. Higher scores indicate 
worse sleeping or impact of sleep, with scores greater than 60 considered elevated. 
 
Functional Outcomes of Sleep Questionnaire 10-item (FOSQ-10): The FOSQ-1016 is a 10-item 
assessment that assesses the impact of sleep on daily functioning, such as driving and working. Each item 
was scored on a 4-point Likert scale and summed. Lower scores suggest greater impairment due to sleep-
related issues. 
 
General Anxiety Disorder 7 (GAD-7): The GAD-717 is a 7-item questionnaire designed to assess the 
severity of generalized anxiety disorder symptoms. Each item is scored on a 4-point Likert scale. 
Questions indicating negative affect were coded and summed. Questions indicating positive affect were 
reverse scored, then summed for a total score. Higher scores indicate more severe general anxiety. 
 
Perceived Stress Scale (PSS): The PSS18 is a 10-item questionnaire that measures the degree to which 
individuals are stressed in the past month. Each item is scored on a 5-point Likert scale. Questions 
indicating negative affect were coded and summed. Questions indicating positive affect were reverse 
scored. Higher scores indicate a greater amount of perceived stress. 
 
Patient Health Questionnaire 8: The Patient Health Questionnaire 819 is an 8-item assessment to determine 
the degree to which a respondent experiences depressive symptoms. Each item corresponds to diagnostic 
criteria for major depressive disorder, such as little interest in doing things, or trouble concentrating. Each 
question is scored and added together on a 4-point Likert scale. Higher scores indicate a greater severity 
of depressive symptoms. Scores > 10 indicate the presence of depressive symptoms. 
 
Sleep Diary: Participants completed items from the Consensus Sleep diary.20 Items include bedtime, sleep 
latency, number of awakenings, total duration of awakenings, final wake time and rise time. It also 

7 
 
 
provided the opportunity to comment on any unusual event that may have occurred. Using these diaries, 
we calculated sleep latency, sleep duration, wake after sleep onset, and sleep efficiency. Sleep diary data 
was cleaned (e.g., reviewed for AM/PM errors, negative sleep efficiencies and sleep efficiencies >1) 
diaries were considered valid if participants had at least 4 valid days completed. 
 
Objective sleep/wake estimation: Sleep-wake data was estimated using a Charge 5 Fitbit that was worn 
during the baseline week, the first week of the trial, and the last week of the trial. Fitbits are comparable 
to research-grade actigraphy for estimating sleep duration.21 Fitbit data was collected and aggregated 
using the Fitabase platform. Fitbit-derived sleep variables included total sleep time, wake after sleep onset 
(WASO) and sleep efficiency (percent asleep divided by the sleep period time). Sleep periods were auto-
scored, and therefore the sleep latency variable was not valid. The sleep variables were scored by the 
Fitbit algorithm, using the stages algorithm (with heart rate data) when possible, and if not available using 
the classic (movement only) algorithm. Most days both pre and post for each group were scored using the 
stages algorithm (>90%) and therefore all valid days were used in the analysis. To determine a valid day, 
we first identified the primary sleep period. Primary sleep periods <2 h were excluded if the sleep diary 
did not corroborate the very short sleep period. Fitbit data were considered valid if participants had at 
least 4 nights of valid data. 
 
Evolv28 adherence: Evolv28 adherence was collected via the company’s dashboard. The dashboard was 
password protected and only study staff not associated with screening and assessments had access to this 
data. The dashboard contained participant ID, group assignment (intervention or control) and device 
usage (average and total). 
 
Adverse events: At 4-weeks and 3-months, participants completed a measure that asked if they 
experienced any symptoms while wearing the sleep device, when they developed, and their degree of 

8 
 
 
severity. In addition, if participants reported to study staff any effects of the device, these were recorded 
in an adverse event log and if necessary, reported to the IRB. 
 
Data analysis 
Data were analyzed using R version 4.2.2. We utilized descriptive statistics to describe the sample 
statistics at baseline. Then, we conducted linear mixed models to the effect for time and time x group 
interaction. The primary outcome was defined as change in ISI at 1-month. We also conducted linear 
mixed models to examine change over time and time x group changes from baseline to 3-months. 
Analyses were conducted as intention to treat and all participants who completed baseline data and were 
randomized were included in the mixed models. We utilized chi-square tests to evaluate percentage with a 
response to the intervention (decrease of 6 points or more on the ISI) and remission (ISI post-intervention 
score <7). An a-priori power analysis, assuming a medium-to-large effect size of d = 0.74, indicated that a 
total sample size of 60 participants (30 per group) would provide a power of 80% to detect significant 
differences with a two-sided alpha level of 0.05.  
 
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Figure Captions 
Figure 1 
CONSORT Flowchart of Participants 
Figure 2 
Response and Remission 
Note. Response and remission scores of participants are shown for control and intervention groups. 
Response is a clinically meaningful reduction in Insomnia Severity Index score (change of 6 or more) 
from screening to end of the 1-month trial. Remission is an Insomnia Severity Index score of 7 or below 
at the end of the 1-month trial.

13 
 
 
           Table 1 
Baseline characteristics 
Intervention  
M, SD or N, % 
Control 
M, SD or N, % 
Full sample 
M, SD or N, % 
Age (years) 
38.9 
12.5 
41.6 
11.8 
40.4 12.1 
Sex 
 
 
   Female 
19 
68 
20 
65 
39 66 
   Male 
9 
32 
11 
35 
20 34 
 
Race 
 
 
 
 
 
   White 
20 
71 
22 
71 
42 71 
   Asian 
6 
21 
4 
13 
10 17 
   Black/African American 
2 
7 
4 
13 
6 
10 
   Native Hawaiian or other 
     Pacific Islander 
0 
0 
1 
3 
1 
2 
 
Ethnicity 
 
 
 
 
 
    Hispanic/Latino 
1 
4 
4 
13 
5 
8 
   Non-Hispanic/Latino 
27 
96 
27 
87 
54 92 
 
Employment Status 
 
 
 
 
 
   Full-timea 
13 
46 
18 
58 
31 53 
   Part-timea 
5 
18 
6 
18 
11 19 
   Student 
3 
11 
3 
11 
6 
10 
   Not employed 
5 
18 
3 
10 
8 
14 
   Retired 
2 
7 
1 
4 
3 
5 
Highest level of education 
 
 
 
 
   Completed high school or some high 
    school 
5 
18 
5 
16 
10 17 
   Associate degree or trade school 
8 
29 
6 
19 
14 24 
   Bachelor’s degree 
8 
29 
9 
29 
17 29 
   Graduate degree 
7 
25 
11 
35 
18 31 
 
 
 
 

14 
 
 
 
Sociodemographic Characteristics of Participants at Baseline 
 
Note. N = 59 (n = 28 for intervention and n = 31 for control). Participants were on average 40.4 years old (SD = 
12.1), and participant age did not differ by condition. a Full-time reflects 32 hours or more of work per week. Part-
time reflects less than 32 hours of work per week. 
Combined yearly household income 
 
 
 
 
$25,000 or below 
3 
11 
6 
19 
9 
15 
$26,000-$50,000 
6 
21 
4 
13 
10 17 
$51,000-$75,000 
8 
29 
6 
19 
14 24 
$76,000-$100,000 
4 
14 
6 
19 
10 17 
>$101,000 
6 
21 
6 
19 
12 20 
Prefer not to say 
1 
4 
3 
10 
4 
7 

15 
 
 
Table 2. Self-Reported Outcomes at 1 Month 
Assessment 
Intervention 
Control 
pbetween pwithin 
Baseline 
1-month 
Change 
Baseline 
1-month 
Change 
M 
SD 
M 
SD 
M 
SD 
M 
SD 
M 
SD 
M 
SD 
Insomnia 
Severity 
 Index 
19.1 3.3 
11.8 
5.2 
-7.34 a 1.87 
18.6 3.2 
11.0 
4.0 
-7.58 a .84 
0.88 
0.001 
PROMIS Sleep 
 Disturbance 
60.6 5.9 
7.9 
7.9 
-6.80 a 2.02 
60.8 4.9 
53.5 
4.9 
-7.28 a .05 
0.98 
0.001 
PROMIS Sleep- 
 Related 
Impairment 
61.0 6.1 
56.0 
8.0 
-4.97 a 1.85 
60.4 6.2 
53.4 
8.1 
-7.02 a 1.97 
0.37 
0.001 
General Anxiety  
  Disorder 
7.00 4.9 
5.72 
4.6 
-1.28 a -0.27 
6.71 4.2 
4.90 
3.5 
-1.81 a -0.65 
0.53 
0.005 
Perceived Stress 
  Scale 
16.9 6.4 
15.8 
7.6 
-1.13  1.19 
16.4 6.7 
15.7 
6.2 
-0.76 
-.49 
0.87 
0.44 
Functional 
  Outcomes of 
Sleep 
32.8 3.9 
35.8 
4.9 
+3.05 a 1.00 
31.8 5.6 
35.2 
4.7 
+3.44 a -0.90 
0.81 
0.002 
Patient Health 
  Questionnaire 
7.40 3.6 
5.4 
3.6 
-2.00 a -0.07 
7.7 
3.6 
4.7 
3.4 
-2.99 a -0.23 
0.39 
0.001 
 
Note.  Missing questionnaire data N = 3 in the intervention group and N  = 2 for the control group. Pbetween= p value for the time x condition effect, 
pwithin= p value for the time effect.  
 
 

16 
 
 
Table 3. Fitbit and Sleep Diary Outcomes at 1 Month 
Assessment 
Intervention 
Control 
pbetween pwithin 
Baseline 
1-month 
Change 
Baseline 
1-month 
Change 
M 
SD 
M 
SD 
M 
SD 
M 
SD 
M 
SD 
M 
SD 
Sleep diary 
 
 
  Sleep duration (h) 
6.36 1.77 
6.89 
2.08 
+0.53 a +0.30 
6.36 1.5 
6.64 
1.86 
+.28 a 
+0.34 0.25 
0.046 
  Wakefulness after 
    sleep onset (m) 
34.8 53.4 
28.8 
49.8 
-6.0 
-3.39 
29.3 44.4 
31.8 
42.0 
+2.4 
-2.67 
0.37 
0.73 
  Efficiency (%) 
75.0 0.16 
79 
0.15 
+0.04 -0.01 
78.0 0.14 
77.0 
0.16 
-0.01 
+0.02 0.03 
0.90 
  Sleep latency (m) 
43.2 46.2 
39 
42.0 
-4.2 
-4.69 
41.4 41.4 
43.2 
52.2 
+1.8 
+10.70 0.07 
0.63 
Fitbit 
 
 
  Sleep Duration (h) 
6.28 0.58 
6.47 
1.02 
+0.19 +0.43 
6.37 0.88 
6.47 
1.45 
+0.1 
+0.57 0.80 
0.70 
  Wake after 
    sleep onset (m) 
48.8 8.1 
51.4 
17.7 
+2.6 
+9.60 
50.9 17.2 
49.8 
16.9 
-0.9 
-0.33 
0.46 
0.74 
  Efficiency (%) 
93.6 2.6 
92.9 
5.8 
-0.7 
+3.22 
93.9 2.4 
94.1 
2.80 
+0.2 
+0.34 0.55 
0.81 
 
Note. Missing data for actigraphy (n=23), missing data for sleep diaries (n= ).  p= pbetween= p value for the time x condition effect, pwithin= p value 
for the time effect.  
 
 

17 
 
 
Table 4. Results of Self-Reported Outcomes at 3-Months 
Assessment 
Intervention 
Control 
pbetween pwithin 
Baseline 
3-month 
Change 
Baseline 
3-month 
Change 
M 
SD 
M 
SD 
M 
SD 
M 
SD 
M 
SD 
M 
SD 
Insomnia Severity 
  Index 
19.1 3.3 
11.2 
4.7 
-7.98 a +1.36 
18.6 3.2 
9.3 
4.5 
-9.31 a +1.29 0.360 0.001 
PROMIS Sleep 
  Disturbance 
60.6 5.9 
53.7 
8.0 
-6.84 a +2.16 
60.8 4.9 
52.4 
6.5 
-8.37 a +1.67 0.478 0.001 
PROMIS Sleep- 
 Related Impairment 
61.0 6.1 
56.2 
9.4 
-4.81 a +3.30 
60.4 6.2 
52.6 
9.1 
-7.84 a +2.94 0.246 0.001 
General Anxiety  
  Disorder 
7.0 
4.85 
7.24 
5.6 
+0.24 +5.06 
6.71 4.2 
5.13 
5.4 
-1.58 
+5.83 0.284 0.338 
Perceived Stress 
  Scale 
16.9 6.37 
17.5 
7.6 
+0.6 
+1.23 
16.4 6.7 
15.0 
7.8 
-1.4 
+1.10 0.254 0.227 
Functional 
  Outcomes of Sleep 
32.8 3.85 
34.6 
5.9 
+1.8 a +2.07 
31.8 5.6 
35.2 
5.4 
+3.4 a -0.13 
0.319 0.004 
Patient Health 
  Questionnaire 
7.4 
3.64 
7.1 
4.8 
-0.3 a 
+1.20 
7.6 
3.6 
5.4 
4.7 
-2.2 a 
+1.09 0.111 0.007 
 
Note.  Missing data n=1 at the 3-month assessment. Pbetween= p value for the time x condition effect, pwithin= p value for the time effect.