Use of Bioboosti Non-pharmacologic Device for Insomnia Treatment: A Pilot Study
Phase: NA
Conditions: Insomnia
Sponsor: Brigham and Women's Hospital

 
  
Cover page  
  
Study Official Title: Use of Bioboosti Non-pharmacologic Device for Insomnia Treatment - a 
pilot study   
  
NCT#: NCT02924116   
  
Version Date of the Document: 06/04/2018  
 

Partners Human Subjects Research Application Form   
  
Filename: Protocol Summary  
Version Date:  October 15, 2014  
  
   
1  
PARTNERS HUMAN RESEARCH COMMITTEE PROTOCOL 
SUMMARY  
  
Answer all questions accurately and completely in order to provide the PHRC with the relevant 
information to assess the risk-benefit ratio for the study.  Do not leave sections blank.  
  
PRINCIPAL/OVERALL INVESTIGATOR  
Milena Pavlova, MD  
  
PROTOCOL TITLE  
Use of Bioboosti Non-pharmacologic Device for Insomnia Treatment – a pilot 
study  
  
  
FUNDING  
Biomobie (Shanghai) Regenerative Medicine Technology Co., Ltd.  
  
  
VERSION DATE  
  
06/04/2018  
  
SPECIFIC AIMS  
Concisely state the objectives of the study and the hypothesis being tested.  
Hypothesis 1: Patients with insomnia have longer, more consolidated sleep 
after treatment with Bioboosti.     
Specific Aim 1: This hypothesis will be tested in a prospective study, using 
within subject comparisons, whereby sleep measures before treatment are 
compared to those after treatment.   
Hypothesis 2: Sleep improvement will lead to a lesser subjective daytime 
sleepiness and reduction in migraine frequency/intensity.    
Specific Aim 2: This hypothesis will be tested by comparing subjective 
measures of sleepiness, measured by standard instruments (Epworth 
sleepiness scale score, ESS, Karolinska sleepiness scale KSS), relative to 
total sleep time and wake after sleep onset.  Migraine frequency and 
intensity will be recorded using standardized headache diaries.    
Exploratory aim: To evaluate the physiological mechanisms, by which 
Bioboosti may exert its effect on sleep and overall health.  This will be 
accomplished by a measurement of hormones directly affecting sleep and 

Partners Human Subjects Research Application Form   
    
Filename: Protocol Summary  
Version Date:  October 15, 2014  
  
   
2  
sympathetic autonomic nervous system (urinary cortisol and 
catecholamines), immune, as well as autonomic function.  
  
Arm 1   
Aim 1:To test the hypothesis that treatment with BioBoosti has sustained 
efficacy in treating insomnia.  
Our primary endpoint would be insomnia symptoms after 1 year of BioBoosti 
use as compared to initial symptoms (prior to starting treatment).    
Measurement of insomnia will be done in serial comparisons every 3 months 
for ISI, TST(Total Sleep Time), WASO(Wake After Sleep Onset), as well a 
PSQI at year 1.  We will use repeated measures ANOVA to compare ISI, 
TST, WASO, at months 3,6,9, and 12 and a T-test to compare PSQI at 
baseline to that after 1 year.  
Arms 2                                                                                                       
Aim 2: To test the hypothesis that patient with Insomnia and comorbid 
Migraine will have longer, more consolidated sleep with lesser migraine 
frequency/intensity after treatment with BioBoosti.   
  
  
  
BACKGROUND AND SIGNIFICANCE  
Provide a brief paragraph summarizing prior experience important for understanding the 
proposed study and procedures.  
Insomnia is a leading health complaint, seen in almost 25% of the 
population.  Insomnia complaints can be associated not only with discomfort 
for the patient, but also with loss of productivity, poor health, and a higher 
healthcare utilization.  Insufficient or poor quality sleep increases the risk of 
a variety of disorders, leading to abnormalities of endocrine (Buxton, 
Pavlova et al 2010) and immune function (Lange et al 2011). Insomnia 
probably has the some of the same consequences as insufficient sleep from 
other causes. For example, in a recent study in our group (Buxton, Pavlova 
et al, 2011), we found that sleep fragmentation, as measured by wake after 
sleep onset (WASO), predicts diabetes risk in insomnia patients.  
  
Treatment of insomnia is particularly challenging among patients with 
comorbidities, where insomnia is also more common. For example, insomnia 
is seen in 40-51% of patients with epilepsy (Vendrame 2013, Lopez et al 
2013).  Many studies indicate that patients with epilepsy frequently have 
fragmented sleep, as well as excessive daytime somnolence (Holoway et al 
2011, Meyer et al 2011, Manni et al 2010, Krishnan et al 2012). Yet 
treatment of insomnia in these patients is very challenging, as many of the 

Partners Human Subjects Research Application Form   
  
Filename: Protocol Summary  
Version Date:  October 15, 2014  
  
   
3  
frequently used medications may interact with antiepileptic medications, or 
affect seizure threshold.  For example, benzodiazepines, which are among 
the most commonly used of treatment of insomnia, can be associated with 
withdrawal seizures, and are particularly risky in these patients. Similar 
considerations exist for the patients with cardiac disease and dementia.  For 
example, although long term benzodiazepine use can be associated with 
frequent falls (Berry et al, 2015), impaired memory (Billioti et al, 2015) and 
even all-cause mortality (Iennum et al, 2015), they are frequently 
prescribed and needed.  From a recent review (Defrancesco, et al, 2015) it 
can be inferred that every fifth patient with Alzheimer’s disease will need 
benzodiazepine treatment.    
  
Sleep disturbances can serve as a trigger for migraines, and insomnia in 
particular is a common comorbidity in patients with chronic migraine.  
Addressing insomnia in patients with chronic migraine can result in 
reductions in migraine frequency (Smitherman, et al, 2016)   
  
  
The use of non-pharmacologic treatments of insomnia has gained much 
attention in recent years.  For example, lectures on use of yoga in the 
treatment received a very high attendance at a recent CME course lead by 
the principal investigator of this study. This is only one example of the 
importance and high impact of any such research.  
  
A safe, non-pharmacologic treatment of insomnia is very much needed 
to help patients with insomnia, especially those with comorbidities. Studies 
have tested the use of pulsed electromagnetic fields on bone healing 
(Chalidis et al 2011), wound healing (Cheing et al 2014), peripheral nerve 
regeneration (Kim et al 2002), neuropathic pain in diabetics (Weintraub et al 
2009), and cardiac function after a myocardial infarct (Hao et al 2014). A 
post-market follow up has shown that the Bioboosti, a device that emits 
micromagnetic fields, can be effective as an adjuvant therapy for a number 
of conditions including insomnia (Biomobie 2015). We propose a pilot study 
to assess the effectiveness of FDA approved Biomobie device (Bioboosti) for 
the treatment of insomnia.  
  
RESEARCH DESIGN AND METHODS  
Briefly describe study design and anticipated enrollment, i.e., number of subjects to be enrolled 
by researchers study-wide and by Partners researchers.  Provide a brief summary of the eligibility 
criteria (for example, age range, gender, medical condition).  Include any local site restrictions, 
for example, “Enrollment at Partners will be limited to adults although the sponsor’s protocol is 
open to both children and adults.” 
This is an investigator-initiated study looking at the effects of the Bioboosti 
device on sleep for patients who have been diagnosed with insomnia and 
chronic migraine (15 or more headache days per month according to the 
International Classification of Headache Disorders III-Beta). We will screen 

Partners Human Subjects Research Application Form   
    
Filename: Protocol Summary  
Version Date:  October 15, 2014  
  
   
4  
and enroll patients with insomnia and chronic migraine who are >18 years 
old for consistency on sleep data and age range. The study protocol consists 
of enrollment; baseline sleep and headache assessment, actiwatch use and 
set up of EEG; removal of the EEG then two weeks of treatment with 
Bioboosti; a post-treatment sleep assessment followed by a final visit to 
remove the EEG.   
Adult patients >18 years old seen in the BWH and FH sleep and headache 
clinics are eligible for participation in the study. As we are unsure of the 
effects that the Bioboosti has on the general population, and in turn the 
various effects of chronic conditions on a person’s sleep, we will exclude 
patients with known untreated moderate or severe sleep apnea, or with 
major circadian rhythm disorders, as these may confound our analyses. We 
will also exclude patients who are pregnant or breastfeeding; patients with 
cardiac pacemaker; any electrical devices; patients with cancer; patients 
with severe conditions related to heart, brain, kidney and hematopoietic 
system; patients with severe/unstable angina pectoris, arteria 
coronaria/peripheral arterial bypass graft, congestive heart failure, renal 
insufficiency, mechanical intestinal obstruction. Subjects with medication 
overuse headache defined as using specified abortive medications 9 or more 
days per month will also be excluded.  Abortive medications for the purposes 
of this study will include opioids, combinations analgesics (barbiturates 
and/or caffeine contain medications), and triptans.    
We anticipate enrolling 20 subjects at Brigham and Women’s and Faulkner 
Hospitals.  
We do not anticipate all 20 subjects to participate however, interested 
enrolled subjects will also be offered to continue the treatment for one year 
for the evaluation of sustained efficacy of BioBoosti as Insomnia Treatment. 
We anticipate enrolling up to 20 subjects at BWH and Faulkner Hospitals.  
The study will also look at the effects of the BioBoosti device on sleep and 
recurrence of headache for patients who have been diagnosed with both 
insomnia and migraine. The study protocol remains the same besides the 
treatment with BioBoosti will be for 4 weeks to allow adequate headache 
assessment.  
We anticipate enrolling 20 additional subjects with insomnia and comorbid 
migraine at Brigham and Women’s and Faulkner Hospitals.  
  
  
Briefly describe study procedures.  Include any local site restrictions, for example, “Subjects 
enrolled at Partners will not participate in the pharmacokinetic portion of the study.”  Describe 
study endpoints. 

Partners Human Subjects Research Application Form   
  
Filename: Protocol Summary  
Version Date:  October 15, 2014  
  
   
5  
The BWH and FH sleep clinics will be screened for follow-up patients with 
insomnia. Study staff will notify the treating physician to inform them of a 
potential subject. The treating physician will first introduce the study to the 
potential subject. If the subject gives permission and would like to obtain 
more information regarding the study, study staff will approach them and 
provide them with a copy of the consent form to review. Study staff may 
also contact the subject by phone to explain the study and recruit if it is 
more convenient for the subject. Study staff and a physician investigator will 
be available to answer all questions. If the potential subject is interested in 
participating in the study, the Principal Investigator will consult with the 
treating physician prior to enrolling the subject. If the subject decides to 
enroll in the study when approached in the clinic, we will proceed with Visit 1 
(Enrollment Visit) that same day. The physician investigator will be available 
to speak with subjects during the consent process.  
For Insomnia  
Visit 1  
Subjects who are interested in participating will sign the consent form. A 
screening physical exam will be done, and vital signs (blood pressure, heart 
rate, pulse rate, respiratory rate) will be measured. Pregnancy test will be 
done for women of childbearing potential.   
Subjects will go home with sleep logs, which are subject records of when 
they go to sleep and wake up. They will also be given an actiwatch to wear, 
as an objective measure of sleep and wake periods.  
Visit 2  
Subjects will be scheduled for a follow up at FH.  
Subjective sleep symptoms will be evaluated using validated instruments, 
including Pittsburgh Sleep Quality Inventory (PSQI), and severity of 
insomnia - Insomnia Severity Index (ISI), and daytime sleepiness Epworth 
Sleepiness Scale (ESS), and daily visual analog scale (Karolinska sleepiness 
scale, KSS).  
Objective sleep assessment will be performed using ambulatory 72 hour 
EEG, using sleep montage per standard AASM criteria, and scored by a 
registered polysomnography technologist using AASM guidelines. If the 
subject expresses hesitation because of the 72 hour EEG, then a 48 hour 
EEG will be offered.  
  
Assessment of sympathetic autonomic nervous system function will be done 
by measuring cortisol and catecholamine levels using standard assays.   

Partners Human Subjects Research Application Form   
    
Filename: Protocol Summary  
Version Date:  October 15, 2014  
  
   
6  
  
Subjects will continue to wear the actiwatch and complete sleep logs daily.  
  
Visit 3  
Subjects will return for the EEG to be removed. Subjects will be given a 
Bioboosti for the treatment phase and instructed on how to use it. The 
research assistant will be trained in person by a Bioboosti representative. 
Using the device as part of the training, the research assistant will learn the 
proper placement of the device on the hands, what the different buttons 
represent and how to properly charge it. He/she will in turn instruct the 
participants with this information. Subjects will continue to use the 
actiwatch.  
  
  
Treatment phase  
There will be two weeks of treatment with Bioboosti. Subjects will be asked 
to use the device once a day, at approximately one hour prior to initiation of 
habitual sleep time. They will complete up to 6 therapy cycles. A therapy 
cycle consists of placing the Bioboosti on the Laogong point, which is located 
at the center of the palm. The device will remain there for 8 minutes, and 
this counts as 1 cycle. When the light on the device changes, it indicates 
that 8 minutes have passed, and a cycle is completed. The subject will then 
remove the device and replace it on the Laogong point of the other hand. 
The subject will repeat this up to 6 times, alternating the treatment cycles 
between one hand to another.   
They will complete sleep logs for two weeks, as well as wear the actiwatch.  
During this time, subjects should not drive while using the Bioboosti. They 
will also be advised to maintain a healthy lifestyle, as is done during clinic 
visits (light diet, regular exercise, smoking cessation, abstinence and 
sufficient sleep), but these are not terms of exclusion from the study.    
Visit 4  
Subjects will return after the two weeks of treatment. They will return the 
completed sleep logs.   
Subjective sleep symptoms will be evaluated using validated instruments 
including, Pittsburgh Sleep Quality Inventory (PSQI), and severity of 
insomnia - Insomnia Severity Index (ISI), and daytime sleepiness Epworth 
Sleepiness Scale (ESS), and daily visual analog scale (Karolinska sleepiness 
scale, KSS).  

Partners Human Subjects Research Application Form   
  
Filename: Protocol Summary  
Version Date:  October 15, 2014  
  
   
7  
Objective sleep assessment will be performed using ambulatory 72 hour 
EEG, using sleep montage per standard AASM criteria, and scored by a 
registered polysomnography technologist using AASM guidelines. If the 
subject expresses hesitation because of the 72 hour EEG, then a 48 hour 
EEG will be offered.  
  
Assessment of urine cortisol and catecholamines will be done as a measure 
of sympathetic function.  
  
Subjects will continue to wear the actiwatch and complete sleep logs daily.   
Visit 5  
Subjects will return for the EEG to be removed. They will return the 
Bioboosti, actiwatch and completed sleep logs.  
  
The Bioboosti devices will be checked on their return to the study staff. If it 
is determined that the device is not functioning properly, the participant will 
be asked to redo the study.  
  
Testing of each patient requires about one month as outlined above. With 
efficient recruitment and minimal attrition rate, 20 participants can complete 
the study.   
  
Sustained Efficacy Phase  
  
Subjects participating in the study will also be asked if they are interested in 
the long-term use of BioBoosti device. In that case, they will be consented 
again to go forward with the long-term use. At the end of this process, they 
will be given sleep and headache logs.  
  
They will be offered to continue the treatment for one year with regular 
follow-up. One month prior to each follow-up they will be asked to use the 
actiwatch to objectively evaluate the sleep patterns. They will either pick up 
the device or will be offered a home visit for the actiwatch use.  
  
  
  
  
Visit at 3rd,6th, 9th months  
• 
Subjects will complete the Insomnia Severity Index (ISI) and 
Pittsburgh Sleep Quality Inventory (PSQI).   
• 
They will return the completed sleep logs.  
• 
They will be asked to continue filling out new sleep logs for the 
following visit.   
• 
They will return the Actiwatch.  

Partners Human Subjects Research Application Form   
    
Filename: Protocol Summary  
Version Date:  October 15, 2014  
  
   
8  
  
Visit at 12th month  
  
Subjects will be asked to return the sleep logs and actiwatch and will 
be asked to complete the Pittsburgh Sleep Quality Inventory (PSQI), and 
Insomnia Severity Index (ISI), and daytime sleepiness Epworth Sleepiness 
Scale (ESS).  
  
For Patients with Insomnia and Migraine  
We do not anticipate for this longer testing period to increase the risk, as to 
date, none of the individuals with insomnia have reported any negative 
effects from the treatment.  
Visit 1  
Subjects who are interested in participating will sign the consent form. A 
screening physical exam will be done, and vital signs (blood pressure, heart 
rate, pulse rate, respiratory rate) will be measured. Pregnancy test will be 
done for women of childbearing potential.   
Subjects will go home with sleep logs, which are subject records of when 
they go to sleep and wake up. They will also be given an actiwatch to wear, 
as an objective measure of sleep and wake periods.  
The headache diaries are given which are subject records of the frequency 
and intensity of their migraines. They will complete the logs for one month.  
Visit 2  
Subjects will be scheduled for a follow up at FH one month after the first 
Visit.  
Subjective sleep symptoms will be evaluated using validated instruments, 
including Pittsburgh Sleep Quality Inventory (PSQI), and severity of 
insomnia - Insomnia Severity Index (ISI), and daytime sleepiness Epworth 
Sleepiness Scale (ESS), and daily visual analog scale (Karolinska sleepiness 
scale, KSS).  
Objective sleep assessment will be performed using ambulatory 72 hour 
EEG, using sleep montage per standard AASM criteria, and scored by a 
registered polysomnography technologist using AASM guidelines. If the 
subject expresses hesitation because of the 72 hour EEG, then a 48 hour 
EEG will be offered.  
  
Assessment of sympathetic autonomic nervous system function will be done 
by measuring cortisol and catecholamine levels using standard assays.   
  

Partners Human Subjects Research Application Form   
  
Filename: Protocol Summary  
Version Date:  October 15, 2014  
  
   
9  
Subjects will continue to wear the actiwatch and complete sleep/Headache 
logs daily.  
  
Visit 3  
Subjects will return for the EEG to be removed. Subjects will be given a  
Bioboosti for the treatment phase and instructed on how to use it. He/she 
will in turn instruct the participants with this information. Subjects will 
continue to use the actiwatch.  
  
  
Treatment phase  
There will be one month of treatment with Bioboosti. Subjects will be asked 
to use the device once a day, at approximately one hour prior to initiation of 
habitual sleep time. They will complete up to 6 therapy cycles. A therapy 
cycle consists of placing the Bioboosti on the Laogong point, which is located 
at the center of the palm. The device will remain there for 8 minutes, and 
this counts as 1 cycle. When the light on the device changes, it indicates 
that 8 minutes have passed, and a cycle is completed. The subject will then 
remove the device and replace it on the Laogong point of the other hand. 
The subject will repeat this up to 6 times, alternating the treatment cycles 
between one hand to another.   
They will complete sleep/headache logs for one month, as well as wear the 
actiwatch.  
During this time, subjects should not drive while using the Bioboosti. They 
will also be advised to maintain a healthy lifestyle, as is done during clinic 
visits (light diet, regular exercise, smoking cessation, abstinence and 
sufficient sleep), but these are not terms of exclusion from the study.   
They will be instructed to use their usual migraine abortive treatments that 
were utilized during the run-in phase of data collection, and to avoid the 
introduction of any new therapies during the treatment phase.    
  
Visit 4  
Subjects will return after the one month of treatment. They will return the 
completed sleep logs.   
Subjective sleep symptoms will be evaluated using validated instruments 
including, Pittsburgh Sleep Quality Inventory (PSQI), and severity of 
insomnia - Insomnia Severity Index (ISI), and daytime sleepiness Epworth 

Partners Human Subjects Research Application Form   
    
Filename: Protocol Summary  
Version Date:  October 15, 2014  
  
   
10  
Sleepiness Scale (ESS), and daily visual analog scale (Karolinska sleepiness 
scale, KSS).  
Objective sleep assessment will be performed using ambulatory 72 hour 
EEG, using sleep montage per standard AASM criteria, and scored by a 
registered polysomnography technologist using AASM guidelines. If the 
subject expresses hesitation because of the 72 hour EEG, then a 48 hour 
EEG will be offered.  
  
Assessment of urine cortisol and catecholamines will be done as a measure 
of sympathetic function.  
  
Subjects will continue to wear the actiwatch and complete sleep/headache 
logs daily.   
  
Visit 5  
Subjects will return for the EEG to be removed. They will return the 
Bioboosti.  
They will be asked to continue keeping the sleep/headache logs for another 
month.  
  
The Bioboosti devices will be checked on their return to the study staff. If it 
is determined that the device is not functioning properly, the participant will 
be asked to redo the study.  
  
  
Visit 6  
Subjects will return the completed sleep/headache logs. They will return the 
actiwatch.  
  
  
  
For studies involving treatment or diagnosis, provide information about standard of care at  
Partners (e.g., BWH, MGH) and indicate how the study procedures differ from standard care.  
Provide information on available alternative treatments, procedures, or methods of diagnosis. 
This study does not involve diagnosis. Other than the Bioboosti, the Principal  
Investigator will not make changes to the patient’s medication regimen. 
Other treatments that are available to treat insomnia include: healthy sleep 
hygiene, antihistamines and some prescription medicines like Ambien and 
Lunesta.   
  
As an alternative to standard care, we are proposing to test the Bioboosti 
device as a possible safe, non-pharmacologic treatment option for insomnia.  
  

Partners Human Subjects Research Application Form   
  
Filename: Protocol Summary  
Version Date:  October 15, 2014  
  
   
11  
Describe how risks to subjects are minimized, for example, by using procedures which are 
consistent with sound research design and which do not unnecessarily expose subjects to risk or 
by using procedures already being performed on the subject for diagnostic or treatment purposes. 
Risks of participation may include fatigue from completing the questionnaires 
and feelings of unease answering questions. We will make every attempt to 
schedule and perform the tasks so as to reduce these risks. Subjects may 
refuse to answer any question that upsets them.  
  
When wearing the ambulatory EEG, subjects may feel soreness or see 
reddening of the skin from the glue that is used. There is a risk that the 
cables could become wrapped around the neck, so they should tape the 
cables to their back when sleeping. A registered polysomnography 
technologist will administer the ambulatory EEG so as to minimize these 
risks.    
Subjects may feel discomfort when wearing the actiwatch. The strap is 
adjustable for their comfort.  
  
Collection of specimen data will be done as in routine care.  
  
Based on previously acquired data from the company, we do not anticipate 
any significant likelihood of adverse events. The device has been cleared for 
safety by the FDA. While we don’t anticipate any serious adverse events, it is 
possible that the patients enrolled in the study experience adverse effects of 
the Bioboosti. To minimize risks to subjects, proper use of the bioboosti will 
be explained to them once the device is provided. They will be asked to use 
only the charger that accompanies the Bioboosti; they cannot use it while it 
is charging, as it will not be able to provide therapy while charging. They will 
not use the device when engaging in extreme sports, showering or 
immersing in water. As a possible device for treating insomnia, subjects may 
experience sleepiness when using it. As a precaution, they should not to 
drive while using the Bioboosti. Subjects should handle the device with care 
from trauma so as not to damage it, as well as keeping the device from 
places that are damp, extremely cold or hot, exposure to direct sunlight, 
near any strong magnetic field or microwave field.   
  
Risks will be explained and subjects encouraged to ask questions. In addition 
to the treating physician, we will monitor for any adverse events that might 
be related to the device. Side effects subjects might experience due to the 
Bioboosti will be immediately reported to the treating physician, PI, IRB for 
major adverse effects as well as sponsor. If any significant events occur, 
these may lead to the need to discontinue the treatment.  
  
Describe explicitly the methods for ensuring the safety of subjects.  Provide objective criteria for 
removing a subject from the study, for example, objective criteria for worsening disease/lack of 

Partners Human Subjects Research Application Form   
    
Filename: Protocol Summary  
Version Date:  October 15, 2014  
  
   
12  
improvement and/or unacceptable adverse events.  The inclusion of objective drop criteria is 
especially important in studies designed with placebo control groups. 
Based on previously acquired data from the company, we do not anticipate 
any significant likelihood of adverse events. The device has been cleared for 
safety by the FDA. While we do not anticipate any serious adverse events, it 
is possible that the patients enrolled in the study experience adverse effects 
of the Bioboosti.   
  
To minimize risks to subjects, proper use of the Bioboosti will be explained 
to them once the device is provided, as described above. A manual on how 
to use the device will accompany it. A follow-up phone call will be conducted 
1-2 days after the participant receives the Bioboosti to go over proper use if 
needed. A registered polysomnography technologist will administer the 
ambulatory EEG. Collection of specimen data will be done as in routine care. 
Risks will be explained and subjects encouraged to ask questions.  
  
In addition to the treating physician, we will monitor for any adverse events 
that might be related to the device. Side effects subjects might experience 
due to the Bioboosti will be immediately reported to the treating physician, 
PI, IRB for major adverse effects as well as sponsor. If any significant events 
occur, these may lead to the need to discontinue the treatment  
  
FORESEEABLE RISKS AND DISCOMFORTS  
Provide a brief description of any foreseeable risks and discomforts to subjects.  Include those 
related to drugs/devices/procedures being studied and/or administered/performed solely for 
research purposes.  In addition, include psychosocial risks, and risks related to privacy and 
confidentiality.  When applicable, describe risks to a developing fetus or nursing infant. 
We do not anticipate any serious risks to subjects. Subjects may experience 
discomfort due to fatigue from completing the questionnaires and feelings of 
unease answering questions. We will make every attempt to schedule and 
perform the tasks so as to reduce these risks. Subjects may refuse to 
answer any question that upsets them.   
  
When wearing the ambulatory EEG, subjects may feel soreness or see 
reddening of the skin from the glue that is used. There is a risk that the 
cables could become wrapped around the neck, so the cables should be 
taped to the back especially when sleeping.  
  
Subjects may feel discomfort when wearing the actiwatch. The strap is 
adjustable for their comfort.  
  
As subjects will be starting a new treatment as part of their clinical care 
while in the study, they may experience side effects to the Bioboosti. Based 
on previously acquired data from the company, we do not anticipate any 

Partners Human Subjects Research Application Form   
  
Filename: Protocol Summary  
Version Date:  October 15, 2014  
  
   
13  
significant likelihood of adverse events. The device has been cleared for 
safety by the FDA. As a possible device for treating insomnia, subjects may 
experience sleepiness when using it. As a precaution, they should not to 
drive while using the Bioboosti.  
  
Subjects will be instructed to report any side effects and/or adverse events 
they experience. Side effects will be immediately reported to the treating 
physician and PI, and will be addressed accordingly. However, if any 
significant events occur, these may lead to need to discontinue the 
treatment. Per regulatory guidelines, adverse events will be reported to the 
company.  
  
  
EXPECTED BENEFITS  
Describe both the expected benefits to individual subjects participating in the research and the 
importance of the knowledge that may reasonably be expected to result from the study.  Provide 
a brief, realistic summary of potential benefits to subjects, for example, “It is hoped that the 
treatment will result in a partial reduction in tumor size in at least 25% of the enrolled subjects.”  
Indicate how the results of the study will benefit future patients with the disease/condition being 
studied and/or society, e.g., through increased knowledge of human physiology or behavior, 
improved safety, or technological advances.  
There is no direct benefit to subjects. The Bioboosti is an FDA-approved 
device for the treatment of insomnia. If successful, though there is not 
sufficient data, subjects may experience longer, more consolidated sleep 
after treatment with Bioboosti and this improved sleep will lead to lesser 
subjective daytime sleepiness. The device may help patients with migraine 
by lowering the frequency/intensity of headaches, in addition to improving 
their sleep.  
  
  
EQUITABLE SELECTION OF SUBJECTS  
The risks and benefits of the research must be fairly distributed among the populations that stand 
to benefit from it.  No group of persons, for example, men, women, pregnant women, children, 
and minorities, should be categorically excluded from the research without a good scientific or 
ethical reason to do so.  Please provide the basis for concluding that the study population is 
representative of the population that stands to potentially benefit from this research. 
The subjects for this study will be recruited from the sleep clinics at BWH 
and FH, and will be representative of the population. As we are unsure of the 
effects that the Bioboosti has on the general population, and in turn the 
various effects of chronic conditions on a person’s sleep, we will exclude 
patients with known untreated moderate or severe sleep apnea, or with 
major circadian rhythm disorders, as these may confound our analyses. We 
will also exclude patients who are pregnant or breastfeeding; patients with 
cardiac pacemaker; any electrical devices; patients with cancer; patients 

Partners Human Subjects Research Application Form   
    
Filename: Protocol Summary  
Version Date:  October 15, 2014  
  
   
14  
with severe conditions related to heart, brain, kidney and hematopoietic 
system; patients with severe/unstable angina pectoris, arteria 
coronaria/peripheral arterial bypass graft, congestive heart failure, renal 
insufficiency, mechanical intestinal obstruction.  
When people who do not speak English are excluded from participation in the research, provide 
the scientific rationale for doing so.  Individuals who do not speak English should not be denied 
participation in research simply because it is inconvenient to translate the consent form in 
different languages and to have an interpreter present. 
Questionnaires are validated in English. We will not be strictly excluding 
nonEnglish speakers, however given the small number of subjects and the 
large number of information that will be communicated verbally and 
standardized questionnaires, we anticipate that this would be easier for 
English speakers to participate in the study.   
Patients who do not speak English will not be excluded from this study.  We 
will provide potential non-english speaking subjects with the IRB approved 
short form consent form in their native language.  Given that we do not 
anticipate enrolling more than a significant number of non-English speaking 
subjects, we will not have the IRB-approved long-form consent translated.  
A hospital medical interpreter will be scheduled to be present during the 
consent process and entire screening visit.  
  
  
For guidance, refer to the following Partners policy:  
          Obtaining and Documenting Informed Consent of Subjects who do not Speak English           
https://partnershealthcare-public.sharepoint.com/ClinicalResearch/NonEnglish_Speaking_Subjects.1.10.pdf 
  
  
  
RECRUITMENT PROCEDURES  
Explain in detail the specific methodology that will be used to recruit subjects.  Specifically 
address how, when, where and by whom subjects will be identified and approached about 
participation.  Include any specific recruitment methods used to enhance recruitment of women 
and minorities. 
The BWH and FH sleep/hedache clinics will be screened for patients who are 
diagnosed with insomnia and patients with both insomnia and migraine. 
Study staff will notify the treating physician to inform them of a potential 
subject. The treating physician will first introduce the study to the potential 
subject.  If the subject gives permission and would like to obtain more 
information regarding the study, study staff will approach them and provide 
them with a copy of the consent form to review. Study staff may also 
contact the subject by phone to explain the study and recruit if it is more 
convenient for the subject. Study staff and a physician investigator will be 

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available to answer all questions. The physician investigator will be available 
to speak with subjects during the consent process.    
  
Provide details of remuneration, when applicable.  Even when subjects may derive medical 
benefit from participation, it is often the case that extra hospital visits, meals at the hospital, 
parking fees or other inconveniences will result in additional out-of-pocket expenses related to 
study participation.  Investigators may wish to consider providing reimbursement for such 
expenses when funding is available 
Subjects will be paid $400.00 if they complete the study. They will receive 
$100 after the first EEG and the remaining $300 at the end of the study. If 
subjects do not complete the study, they will not be paid for their 
participation. Damage to the devices or unreturned devices is equivalent to 
incompletion of the study. We will also cover the cost of parking up to  
$40.00 for the subject’s study visits.  
  
Sustained Efficacy Phase: Subjects will be paid $350.00 for their 
participation. They will receive $50.00 after the first 3 follow- up and the 
remaining $200.00 at the end of the study and cover the cost of the parking 
for up to $5.00 each visit. Damage to the devices or unreturned devices is 
equivalent to incompletion of the study.  
  
  
 For guidance, refer to the following Partners policies:           Recruitment of Research 
Subjects           https://partnershealthcare- 
public.sharepoint.com/ClinicalResearch/Recruitment_Of_Research_Subjects.pdf 
  
          Guidelines for Advertisements for Recruiting Subjects           https://partnershealthcare- 
public.sharepoint.com/ClinicalResearch/Guidelines_For_Advertisements.1.11.pdf 
  
          Remuneration for Research Subjects           
https://partnershealthcarepublic.sharepoint.com/ClinicalResearch/Remuneration_for_Research_Subjects.pdf 
  
  
CONSENT PROCEDURES  
Explain in detail how, when, where, and by whom consent is obtained, and the timing of consent 
(i.e., how long subjects will be given to consider participation).  For most studies involving more 
than minimal risk and all studies involving investigational drugs/devices, a licensed physician 
investigator must obtain informed consent.  When subjects are to be enrolled from among the 
investigators’ own patients, describe how the potential for coercion will be avoided. 
The BWH and FH sleep clinics will be screened for patients who have been 
diagnosed with insomnia and patients with both insomnia and migraine. 
Study staff will notify the treating physician to inform them of a potential 

Partners Human Subjects Research Application Form   
    
Filename: Protocol Summary  
Version Date:  October 15, 2014  
  
   
16  
subject. The treating physician will first introduce the study to the potential 
subject.  If the subject gives permission and would like to obtain more 
information regarding the study, study staff will approach them and provide 
them with a copy of the consent form to review. Study staff may also 
contact the subject by phone to explain the study and recruit if it is more 
convenient for the subject. Study staff and a physician investigator will be 
available to answer all questions.  If the potential subject is interested in 
participating in the study, the Principal Investigator will consult with the 
treating physician prior to enrolling the subject. The subject will be 
encouraged to ask questions. If the subject is still unsure if he/she wants to 
participate, he/she will be encouraged to take the consent form home to 
consider it further. In that case a second visit will be scheduled, the consent 
form reviewed again, and, if signed, study procedures performed. If the 
subject decides to sign informed consent at the time the study is introduced, 
we will proceed with Visit One (Enrollment Visit) that same day. The 
physician investigator will be available to speak with subjects during the 
consent process.  
  
NOTE: When subjects are unable to give consent due to age (minors) or impaired 
decisionmaking capacity, complete the forms for Research Involving Children as Subjects of 
Research and/or Research Involving Individuals with Impaired Decision-making Capacity, 
available on the New Submissions page on the PHRC website:  
      https://partnershealthcare.sharepoint.com/sites/phrmApply/aieipa/irb  
  
For guidance, refer to the following Partners policy:      
Informed Consent of Research Subjects: 
     https://partnershealthcare- 
public.sharepoint.com/ClinicalResearch/Informed_Consent_of_Research_Subjects.pdf 
  
  
  
DATA AND SAFETY MONITORING  
Describe the plan for monitoring the data to ensure the safety of subjects.  The plan should 
include a brief description of (1) the safety and/or efficacy data that will be reviewed; (2) the 
planned frequency of review; and (3) who will be responsible for this review and for determining 
whether the research should be altered or stopped.  Include a brief description of any stopping 
rules for the study, when appropriate.  Depending upon the risk, size and complexity of the 
study, the investigator, an expert group, an independent Data and Safety Monitoring Board 
(DSMB) or others might be assigned primary responsibility for this monitoring activity.         
  
NOTE: Regardless of data and safety monitoring plans by the sponsor or others, the principal 
investigator is ultimately responsible for protecting the rights, safety, and welfare of subjects 
under his/her care.  
The Principal Investigator, Dr. Milena Pavlova, will be responsible for 
overseeing the safety of the subjects in this study. After the first subject is 

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enrolled, she will meet with the study coordinator weekly to review the 
adverse event data collected at each study visit. She will also review any 
complaints about the research at this time. The Principal Investigator and 
study coordinator will review all data collected to ensure that all subjects 
complete questions and logs accurately.  
  
If a subject decides to forgo continuation of the study, the research team will 
ensure their withdrawal in the safest manner possible.  
  
 Describe the plan to be followed by the Principal Investigator/study staff for review of adverse 
events experienced by subjects under his/her care, and when applicable, for review of sponsor 
safety reports and DSMB reports.  Describe the plan for reporting adverse events to the sponsor 
and the Partners’ IRB and, when applicable, for submitting sponsor safety reports and DSMB 
reports to the Partners’ IRBs.  When the investigator is also the sponsor of the IND/IDE, include  
 the plan for reporting of adverse events to the FDA and, when applicable, to investigators at 
other sites.    
  
NOTE: In addition to the adverse event reporting requirements of the sponsor, the principal 
investigator must follow the Partners Human Research Committee guidelines for Adverse Event  
Reporting 
Adverse events will be reported to the Principal Investigator weekly. Any 
serious adverse events will be reported within 24 hours.   
  
Adverse events that are serious, unexpected, and related or possibly related 
to the research study will be reported to the IRB within 5 working days/ 7 
calendar days after the investigator becomes aware of the event.   
  
MONITORING AND QUALITY ASSURANCE  
 Describe the plan to be followed by the principal investigator/study staff to monitor and assure 
the validity and integrity of the data and adherence to the IRB-approved protocol.  Specify who 
will be responsible for monitoring, and the planned frequency of monitoring.  For example, 
specify who will review the accuracy and completeness of case report form entries, source 
documents, and informed consent.    
  
NOTE: Regardless of monitoring plans by the sponsor or others, the principal investigator is 
ultimately responsible for ensuring that the study is conducted at his/her investigative site in 
accordance with the IRB-approved protocol, and applicable regulations and requirements of the 
IRB. 
The Principal Investigator, Dr. Milena Pavlova, will ultimately be responsible 
for data integrity and quality assurance. The study coordinator will be 
responsible for accurate collection of the data. Data will be reviewed 
throughout the period of collection to ensure that subjects provide accurate 
information.  She will review all collected data weekly.  
  
  

Partners Human Subjects Research Application Form   
    
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For guidance, refer to the following Partners policies:  
          Data and Safety Monitoring Plans and Quality Assurance             
https://partnershealthcare- 
public.sharepoint.com/ClinicalResearch/DSMP_in_Human_Subjects_Research.pdf   
           
          Reporting Unanticipated Problems (including Adverse Events)           
https://partnershealthcare- 
public.sharepoint.com/ClinicalResearch/Reporting_Unanticipated_Problems_including_Adverse_Events.pdf 
  
  
  
PRIVACY AND CONFIDENTIALITY  
Describe methods used to protect the privacy of subjects and maintain confidentiality of data 
collected.  This typically includes such practices as substituting codes for names and/or medical 
record numbers; removing face sheets or other identifiers from completed  
surveys/questionnaires; proper disposal of printed computer data; limited access to study data;  
use of password-protected computer databases; training for research staff on the importance of 
confidentiality of data, and storing research records in a secure location.    
  
NOTE: Additional measures, such as obtaining a Certificate of Confidentiality, should be 
considered and are strongly encouraged when the research involves the collection of sensitive 
data, such as sexual, criminal or illegal behaviors. 
Identifiable information such as subject name will be kept in one file while 
data collected from the log entries will be kept in separate file.  An arbitrary 
code number will be issued to each subject so as to locate data information 
without exposing specific identifiable subject information. Study info will be 
kept and stored on password protected shared drives and only accessible on 
Partners workstations.   
  
  
SENDING SPECIMENS/DATA TO RESEARCH COLLABORATORS OUTSIDE 
PARTNERS  
Specimens or data collected by Partners investigators will be sent to research collaborators 
outside Partners, indicate to whom specimens/data will be sent, what information will be sent, 
and whether the specimens/data will contain identifiers that could be used by the outside 
collaborators to link the specimens/data to individual subjects. 
Not applicable.  
  
Urine that will be collected for the study will be analyzed by the Center for 
Clinical Investigation.  
  
Specifically address whether specimens/data will be stored at collaborating sites outside 
Partners for future use not described in the protocol.  Include whether subjects can withdraw 
their specimens/data, and how they would do so.  When appropriate, submit documentation of 
IRB approval from the recipient institution. 

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Filename: Protocol Summary  
Version Date:  October 15, 2014  
  
   
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Not applicable  
  
  
RECEIVING SPECIMENS/DATA FROM RESEARCH COLLABORATORS OUTSIDE 
PARTNERS  
When specimens or data collected by research collaborators outside Partners will be sent to 
Partners investigators, indicate from where the specimens/data will be obtained and whether the 
specimens/data will contain identifiers that could be used by Partners investigators to link the 
specimens/data to individual subjects.  When appropriate, submit documentation of IRB approval 
and a copy of the IRB-approved consent form from the institution where the specimens/data 
were collected. 
Not applicable