Extended Home-use Trial of a Novel Device to Reduce Chronic Neuropathic Pain
Phase: NA
Conditions: Neuropathic Pain, Chronic Pain, Pain
Sponsor: Icahn School of Medicine at Mount Sinai

 
 
 
 
 
 
 
Title: Extended Home-use Trial of a Novel Device to Reduce Chronic Neuropathic Pain 
PI: David Putrino, PT, PhD 
NCT04280562 
Document Date: March 14, 2024 

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Extended home-use trial of a novel device to reduce chronic pain 
 
 
1. BACKGROUND 
 
Device Description and Mechanism of Action: 
 
The Sana Pain Reliever (Sana PR) by Sana Health Inc is a device comprised of one (1) main component 
(Mask with Earbuds) and two (2) ancillary components (Charger and Headband). The device is worn over 
the eyes (with earbuds in ears). The device pulses light at a single wavelength but various frequencies 
throughout a specific firmware algorithm. Through the earbuds, the device also plays different tones in 
conjunction with the pulses. The device has a skin contacting Heart Rate Variability (HRV) sensor built into 
the forehead area that measures HRV throughout use. 
 
The underlying mechanism of action for the Sana PR is Audio Visual Stimulation (AVS), a form of 
neurofeedback and a non-pharmacological intervention that has been used for both performance 
enhancement and symptom management. Light and Sound stimulation has been used for over 100 years. 
In the early 1930s, it was reported that light and sounds stimulation could change the rhythm of brain 
activity, termed "entrainment". As progress was made in this field, several clinical applications of the photic 
and sound stimulation were studied, including; attention deficit and hyperactivity disorder, cognitive 
enhancement, migraine headaches, stress, and pain management. Brain activity can be tracked through 
brainwaves, which represent the electrical firing of the neurons of the central nervous system and can be 
measured by electroencephalogram (EEG). It is through these electrical signals that the brain 
communicates within itself and with other organ systems. Five common brainwave bandwidths (delta, 
theta, alpha, beta and gamma) and the related mental activities have been well described. Within the five 
common brainwave bandwidths, sub categories (high, low alpha and beta, and sensorimotor rhythm) have 
been identified for different mental activities. Specifically, delta activity (0.5–3Hz) is dominant primarily 
during deep sleep. Theta activity (4 – 7Hz) is typically seen in drowsy and relaxed states. Low alpha (8– 
10Hz) is the dominant brainwave bandwidth observed during meditation and the state of turning inward 
(daydreams, dissociation from external stimulation). 
 
When the brain is given a stimulus, through the eyes or ears, it emits a responsive electrical charge, called 
a Cortical Evoked Response. These electrical responses, measured via electrodes, travel throughout the 
brain and is ultimately perceived as vision and audible sound. When the input stimulus resembles a 
pattern the brain itself uses, the brain responds by synchronizing to it, a process called Frequency 
Following Response (FFR). The Sana Mask utilizes this above described AVS mechanism to induce FFR. 
The firmware consists of periods of light/sound pulsing at three distinct pulse frequencies; ~8Hz, 3Hz, and 
1Hz. For each frequency, there are distinct sections where the audio and visual pulses vary from eye to 
eye, and ear to ear. 
 
The website for the device can be found here: https://www.sana.io/ 
Previous Trials Using the Sana PR: 
The Sana Pain Reliever device has been in a previous study entitled "Photic Sleep Enhancement During a 
Mars Analog Exploratory Mission Simulation" that received a Western Institutional Review Board 
Certificate of Approval (attached). Two abstracts from studies involving the device are also attached. 
 
2. Objectives 

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Primary: Determine the effectiveness of the Sana PR at reducing chronic pain over an 8-week 
intervention period and the long-lasting effect of pain relief at a 4-week follow-up using the following 
outcome measures: 
Secondary Objectives: 
1) Determine the impact using the device for an 8-week intervention has on Quality of Life and Sleep 
2) At both baseline visits and both follow-up visits participants will complete a body chart on pen and 
paper to draw out where they feel their pain. Changes to the location of their pain will be measured. 
3) Determine the tolerability and user acceptability of the devices 
 
 
3. 
Device 
 
The Sana Pain Reliever (Sana PR) by Sana Health Inc is a device comprised of one (1) main 
component (Mask with Earbuds) and two (2) ancillary components (Charger and Headband). The 
device is worn over the eyes (with earbuds in ears). The device pulses light at a single wavelength but 
various frequencies throughout a specific firmware algorithm. Through the earbuds, the device also 
plays different tones in conjunction with the pulses. The device has a skin contacting Heart Rate 
Variability (HRV) sensor built into the forehead area that measures HRV throughout use. 
 
Figure 1: the Sana mask 
 
 
 
 
4. 
Study Procedures 
Description of the Study Design 
 
Design: 
Double blind, randomized, sham-controlled trial parallel arm study that will assess the effectiveness and 
patient perception of the benefit of the Sana Pain Reliever in individuals with chronic pain. 

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Device: 
The Sana Pain Reliever (Sana PR) by Sana Health Inc is a device comprised of one (1) main component 
(Mask with Earbuds) and two (2) ancillary components (Charger and Headband). The device is worn over 
the eyes (with earbuds in ears). The device pulses light at a single wavelength but various frequencies 
throughout a specific firmware algorithm. Through the earbuds, the device also plays different tones in 
conjunction with the pulses. The device has a skin contacting Heart Rate Variability (HRV) sensor built into 
the forehead area that measures HRV throughout use. 
- Real Arm 
Each session with the device will last 15 min and run under the device's normal settings. The session 
consists of periods of light/sound pulsing at three distinct pulse frequencies; ~8Hz, 3Hz, and 1Hz. For 
each frequency, there are distinct sections where the audio and visual pulses vary from eye to eye, and 
ear to ear. 
- Sham Arm 
Each session with the device will last 15 min and run under the device's sham setting. For the Sham arm, 
the device will have the light on for 5 min, off for 5 min and then on again for 5 min. Ear plugs will be used 
in place of headphones. There will be no sound from the device in the sham group. 
 
Application: 
The application being used in this study was designed by Sana health specifically for this study. The 
application controls the Sana Pain Reliever device and allows users to use the device. Users must use the 
application to start each session with the device, but the device permits multiple, sequential uses of the 
device without requiring an interaction with the application. The application will be given to participants of 
this study on a tablet device. Participants will also be given the charging equipment for the device. The 
application is HIPAA compliant and will undergo InfoSec review at Mount Sinai. Participants will use the 
application on a tablet device that will be loaned to them for the duration of the study. The application will 
track data for this study during the at-home portions of the study between the two baseline visits, over the 
course of the intervention and between the follow-up visits. 
 
- At-home intervention period (week 2 - 10) - tablet and Sana device: 
The application tracks the number of times the device is used in a day and time stamps those sessions. 
For each session, the application records the HRV data from the forehead sensor of the device and what 
frequency the auditory and visual stimuli the device emitted during the 15 minutes. Prior to and 
immediately after each session the application will ask users to rate the amount of pain they are feeling in 
the moment on a Visual Analog Scale (VAS) along a number line from "no pain" to "worst imaginable 
pain". The first time the device is used each day, participants will be asked to complete a VAS for how 
they slept from the night prior. For the last use of the device prior to going to sleep for the day, participants 
will only be asked to complete the VAS prior to using the device to not disrupt sleep patterns. Additionally, 
at the last use before sleep participants will be asked to select which of their medication for pain 
management they took that day. The medications will appear in a drop-down menu on the application. 
Medications will be reported by each individual to the research team at the first baseline visit week 0 and 
will be inputted by the research team into each participant's application. Every two weeks during the 8- 
week intervention period the application will also prompt users to complete the following additional 
questionnaires: the Neuropathic Pain Symptom Inventory, the Pittsburgh Sleep Quality Index and Patient 
Health Questionnaire Type 9 for Depression (PHQ-9) and the General Anxiety Disorder 7-item 
questionnaire (GAD-7). A reminder to complete these biweekly questionnaires will be sent to participant's 
cell phones via text message and on the tablets themselves. Additionally the application will send 
compliance messages to participants if participants do not fill out the fortnightly questionnaires. 
 
- Between baseline visits (week 0 – 2) and between follow-up visits (week 10 -14) monitoring of pain at 
home – tablet only . 

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During these time periods participants will be asked to use the tablet with the application daily at night 
prior to sleep. Participants will be asked to complete a VAS of how they slept the night prior, a VAS of pain 
and asked to report the medications they used that day for pain management. 
 
Description of Procedures Being Performed 
 
Informed Consent: Participants who fulfill the inclusion/exclusion criteria will be consented to the study at 
the Abilities Research Center at the start of their first in-person study visit or remotely via a telephone call 
to talk through the consent form followed by completion of the E-Consent process ahead of their first 
teleconferenced study visit. 
 
Study devices (mask and tablet) will be shipped together ahead of the first visit for those not completing in- 
person visits. They will be activated and deactivated remotely at the appropriate times. Those completing 
study visits in person will receive and return their devices at different stages of the trial (described below). 
 
INITIAL BASELINE CLINICAL ASSESSMENT (Week 0) - AT THE ARC OR VIA VIDEO CALL 
Screening: After consent has been obtained participants will complete the Beck Depression Inventory 
(BDI) at the initial baseline visit. Individuals who score greater than 30 pts on the scale (Severe or Extreme 
Depression) will be withdrawn from the study. 
 
Participant Information will be collected including: 
- Age, gender, name and contact information (phone number(s) and email address). 
- Current medications: the list of medications will be collected to add to each participant's Sana Health 
application. - A self-reported medical history 
- Documentation of the location of their pain on a body chart 
- Documentation of what pain management techniques participants typically use 
Participants will then complete the following questionnaires: - Neuropathic Pain Symptom Inventory (NPSI) 
- Pittsburgh Sleep Quality Index (PSQI) 
- Beck Depression Inventory (BDI) 
- Patient health Questionnaire Type 9 for Depression (PHQ-9) 
- General Anxiety Disorder 7-item questionnaire (GAD-7) 
- World Health Organization Quality of Life BREF (WHOQOL-BREF) & World Health Organization Quality 
of Life Pain (WHOQOL-pain) 
 
Study Devices: Participants will be loaned a tablet device with the Sana application installed. Participants 
will be instructed on how to use the device and application. 
 
BASELINE PAIN MONITORING (Week 0 - 2) - AT THE HOMES OF THE PARTICIPANTS 
Participants will be asked to use the study tablet with the Sana application daily, at night prior to going to 
sleep. Participants will be asked to complete a Visual Analog Scale (VAS) of how they slept the night prior, 
a VAS of their amount of pain and asked to report the medications and strategies they used that day for 
pain management. 
 
SECOND BASELINE CLINICAL ASSESSMENT (Week 2) - AT THE ARC OR VIA VIDEO CALL 
Participant Information will be collected including: 
- Record of changes in medications 
- Record of changes in pain management techniques participants typically used - Documentation of the 
location of their pain on a body chart 
Participants will then complete the following questionnaires: - Neuropathic Pain Symptom Inventory (NPSI) 
- Pittsburgh Sleep Quality Index (PSQI) 
- Beck Depression Inventory (BDI) 

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- Patient health Questionnaire Type 9 for Depression (PHQ-9) 
- General Anxiety Disorder 7-item questionnaire (GAD-7) 
- World Health Organization Quality of Life BREF (WHOQOL-BREF) & World Health Organization Quality 
of Life Pain 
(WHOQOL-pain) 
 
Study Devices: Participants will be randomized into the Sham or Real study group arm and will undergo a 
Sana PR familiarization session: 
 
ARM 1: Real 
- Participants will be loaned a Sana PR device, headphones, charging cables and a strap to 
secure the device on 
their head 
- The research team will download the Sana Health application on a tablet device compatible with the 
application that 
will be loaned to participants (this device will be a tablet that has all functions not necessary to the 
functionality of the 
Sana application disabled). The device will be loaned to participants for the duration of the 8-week 
intervention. - The research team will teach the participant how to use the Sana PR device and the Sana 
Health application. 
Participants will be given an instruction manual for the device and mobile application. Participants will be 
instructed to call the lab's direct phone-line (212) 824-8369 if they have any additional questions when 
using the device at home. 
- Participants will then complete their first 15 min session with the device in its normal settings under the 
supervision of the research team. For the Real arm, the session with the devices consists of periods of 
light/sound pulsing 
at three distinct pulse frequencies; ~8Hz, 3Hz, and 1Hz. For each frequency, there are distinct sections 
where 
the audio and visual pulses vary from eye to eye, and ear to ear. This first session will ensure the subjects 
know how to properly use the devices and that there are not any adverse events (AEs) from the first use of 
the device. Participants will be instructed to call the lab's direct phone-line (212) 824-8369 if they 
experience an AE when using the device at home. 
 
ARM 2: Sham 
- Participants will be loaned a Sana PR device, earplugs, a charging cable and a strap to secure the 
device on their 
head 
- The research team will download the Sana Health The research team will download the Sana Health 
application 
on a tablet device compatible with the application that will be loaned to participants (this device will be a 
tablet that has all functions not necessary to the functionality of the Sana application disabled). The device 
will be loaned to participants for the duration of the 8-week intervention. 
- The research team will teach the participant how to use the Sana PR device and the Sana Health 
application. Participants will be given an instruction manual for the device and mobile application. 
Participants will be instructed to call the lab's direct phone-line (212) 824-8369 if they have any additional 
questions when using the device at home. 
- Participants will then complete their first 15 min session under the supervision of the research team. For 
the Sham arm, the device will have the light on for 5 min, off for 5 min and then on again for 5 min. Ear 
plugs will be used in place of headphones. There will be no sound from the device in the sham group. This 
familiarity session will ensure the subjects know how to properly use the devices and that there are not 

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any adverse events (AEs) from the first use of the device. Participants will be instructed to call the lab's 
direct phone-line (212) 824-8369 if they experience an AE when using the device at home. 
Safety monitoring: A member of the research team will call the participant 48 hours after the first session 
with device to check for AEs, difficulties using the device and answer any questions. 
 
INTERVENTION (Week 2 - 10) - AT THE HOMES OF THE PARTICIPANTS 
Devices: Participants will be instructed to use the Sana PR every time they experience pain during the day 
(ad libitum). There will be no minimum or maximum number of uses.Participants will open the Sana Health 
application and will be prompted to answer the amount of pain they are feeling in the moment using the 
VAS on the Sana Health application. If it is the first time the participant is using the device for the day, they 
will also be prompted by the application to complete a VAS to report on how they slept the evening prior. 
Participants will then turn on the devices using the application. Participants will complete a 15-min cycle 
with the device. Participants may complete multiple, sequential uses of the devise without requiring them 
to interface with the application. Participants will be prompted to answer the amount of pain they are 
feeling in the moment after using the VAS on the Sana Health application. 
 
Participants will also be asked to use the Sana PR device every evening immediately prior 
to/accompanying falling asleep for the night. Participants will open the Sana Health application and will be 
prompted to answer the amount of pain they are feeling in the moment using the VAS on the Sana Health 
application. Participants will then be prompted as to what medication they took for their pain that day. The 
application will be populated with the medications participants reported at the first baseline visit. 
Participants will select from this list of medications. Participants will complete a 15 min cycle with the 
device. 
 
Every two weeks during the 8-week intervention period participants will receive a message on their cellular 
devices via text message to complete the NPSI, PSQI, PHQ-9 and GAD-7. Participants will be sent 
compliance reminders to complete these questionnaires on their phones and on the tablet. 
Safety monitoring: Participants will be instructed to contact the research team to report any AE over this 
period. Compliance will be monitored over the 8 week intervention period. A significant decrease in the 
compliance during (responding to less than 70% of the last 10 scheduled check-ins) of using the device 
the 8 week intervention will be considered an indication that a participant may need assistance. A 
research team member will call the participant to ensure that the reason of the drop in usage of the device 
is not due to an AE. 
 
POST INTERVENTION FOLLOW UP (Week 10) - AT THE ARC OR VIA VIDEO CALL Participant 
Information will be collected including: 
- Record of changes in medications 
- Record of changes in pain management techniques participants typically used 
- Documentation of the location of their pain on a body chart 
 
Participants will then complete the following questionnaires: 
- Neuropathic Pain Symptom Inventory (NPSI) 
- Pittsburgh Sleep Quality Index (PSQI) 
- Beck Depression Inventory (BDI) 
- Patient health Questionnaire Type 9 for Depression (PHQ-9) 
- General Anxiety Disorder 7-item questionnaire (GAD-7) 
- World Health Organization Quality of Life Bref (WHOQOL-BREF) & World Health Organization Quality of 
Life Pain (WHOQOL-pain) 
- Patient's Global Impression of Change (PGIC) 
- Human Factors Questionnaire 

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- Responses to questions on ease of device use and the likelihood they would hypothetically continue 
using the devices in their daily life. 
 
Devices: Participants will be asked to return the Sana PR mask at this visit. The application will stop 
working to control the device at the end of the 8-week intervention and will not let participants to continue 
using the Sana PR device. 
 
Safety monitoring: Participants will be asked to report any AEs. 
 
CONTINUED PAIN MONITORING BETWEEN FOLLOW UP VISITS (Week 10 – Week 14) - AT THE 
HOMES OF THE PARTICIPANTS 
 
Participants will be asked to use the tablet with the Sana application daily, at night prior to going to sleep. 
Participants will be asked to complete a VAS of how they slept the night prior, a VAS of their amount of 
pain and asked to report the medications they used that day for pain management. 
 
4 WEEK FOLLOW UP VISIT (WEEK 14) - AT THE ARC OR VIA VIDEO CALL Participant information will 
be collected including: 
- Record of changes in medications 
- Record of changes in pain management techniques participants typically used - Documentation of the 
location of their pain on a body chart 
Participants will then complete the following questionnaires: - Neuropathic Pain Symptom Inventory (NPSI) 
- Pittsburgh Sleep Quality Index (PSQI) 
- Beck Depression Inventory (BDI) 
- Patient health Questionnaire Type 9 for Depression (PHQ-9) 
- General Anxiety Disorder 7-item questionnaire (GAD-7) 
- World Health Organization Quality of Life Bref (WHOQOL-BREF) & World Health Organization Quality of 
Life Pain (WHOQOL-pain) 
- Patient's Global Impression of Change (PGIC) 
- Human Factors Questionnaire 
- Responses to questions on ease of device use and the likelihood they would hypothetically continue 
using the devices in their daily life. 
 
Devices: Participants will be asked to return the tablet with the Sana application at this visit 
Safety monitoring; Participants will be asked to report any AEs. 
 
Description of the Source Records that Will Be Used to Collect Data About Subjects 
Self-reported 
 
Description of Data that Will Be Collected Including Long-Term Follow-Up 
- Age, gender, name and contact information (phone number(s) and email address). 
- Current medications: the list of medications will be collected to add to each participant's Sana Health 
application. - A self-reported medical history 
- Documentation of the location of their pain on a body chart 
- Documentation of what pain management techniques participants typically use 
- Neuropathic Pain Symptom Inventory (NPSI) 
- Pittsburgh Sleep Quality Index (PSQI) 
- Beck Depression Inventory (BDI) 
- Patient health Questionnaire Type 9 for Depression (PHQ-9) 
- General Anxiety Disorder 7-item questionnaire (GAD-7) 

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- World Health Organization Quality of Life BREF (WHOQOL-BREF) & World Health Organization Quality 
of Life Pain (WHOQOL-pain) 
- Record of changes in medications 
- Record of changes in pain management techniques participants typically used - Documentation of the 
location of their pain on a body chart 
- Patient's Global Impression of Change (PGIC) 
- Human Factors Questionnaire 
- Responses to questions on ease of device use and the likelihood they would hypothetically continue 
using the devices in their daily life. 
 
4. Subjects 
 
Enrollment goal: 180 participants 
 
Inclusion Criteria 
 
Confirmed clinical diagnosis of neuropathic pain 
 
Ages 18+ 
 
Fluent in English 
 
Consistent medications for the last 4 weeks prior to the first baseline visit (week 0) 
 
Exclusion Criteria 
 
Diagnosis of photosensitive epilepsy 
 
Ear or eye infection 
 
Vision impairments that affect perception of light in one or both eyes 
 
Deafness in one or both ears 
 
Psychiatric disorders (participants will not be excluded if they score 0-30 points on the BDI, or if 
participants self- report having anxiety) 
 
 
5. Data Analysis plan 
 
 
We will use mixed modelling to determine the effect of the intervention on reported chronic pain – our primary 
outcome variable. We will also use ANOVAs (or their non-parametric equivalents) to assess changes in all of our 
outcome measures; including pain scores, sleep scores, device usage statistics, medication usage, heart rate 
variability, blood pressure, and quality of life measures. 
 
 
6. Safety Assessment 
 
Participants will be monitored for possible AEs throughout the study according to the frequency of the data 
review below. Participants will be given the email and phone number of the research team to report AE 
and circumstance of events. Participants will be reminded during the familiarization session with the 
device, at the second baseline visit, to seek immediate medical attention should they experience an injury 
as a result of being in the study. This will also be reiterated to participants if they reach out to report an 
AE. Data from the Sana Health application will be used to track compliance. Significant decrease in the 
compliance during (responding to less than 70% of the last 10 scheduled check-ins) of using the device 
the 8 week intervention will be considered an indication that a participant may need assistance. A 
research team member will call the participant to ensure that the reason of the drop in usage of the device 
is not due to an AE. Any AEs that occurs will be reported to the IRB to see if risk/benefit ratio is still 
acceptable for each individual participant and for the continuation of the study as a whole. 

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7. Benefits 
Although no benefits can be guaranteed, it is possible that subject will experience a reduction in 
amount of chronic pain that they typically experience. 
 
While there is no guarantee that this study will be beneficial to society, we hope that this study will help 
lead to the development of a device that can help reduce chronic pain and provide individuals who 
experience chronic pain with an alternative solution for managing pain. 
 
8. Payment and Remuneration 
There are no expected costs for participants in this study. We will pay participants a maximal total of $150 
for your time and effort. This amount will be pro-rated: they will receive $25 for each of the two baseline 
assessments, and $50 for each of the two follow-up assessments, which amounts to $150. This will be 
paid to them in the form of a check following their final assessment. Checks require some time to be 
prepared and will be given to them as available. Payment is dependent on them returning both the Sana 
PR and tablet devices.