The Efficacy of Intra-oral Neuromuscular Stimulation Training on Primary Snoring
Phase: NA
Conditions: Snoring, Obstructive Sleep Apnea
Sponsor: Signifier Medical Technologies

 
 
RESEARCH PLAN 
 
Version date: 27/12/2018 
1. 
PROJECT TITLE 
The Efficacy of Intra-oral Neuromuscular Stimulation Training on Snoring in Individuals with Primary Snoring  
2. 
PRINCIPAL INVESTIGATOR  
Prof Bhik Kotecha, Chief Investigator   
3. 
FACILITIES 
Queen’s Hospital, Barking, Havering and Redbridge University Hospitals NHS Trust 
Rom Valley Way, Romford, RM7 0AG 
4. 
ESTIMATED DURATION OF THE STUDY 
Up to 2 years 
5. 
LAY LANGUAGE SUMMARY OR SYNOPSIS  
Snoring is part of a spectrum of conditions called Sleep Disordered Breathing (SDB) which spans from Simple 
Snoring to Severe Sleep apnea. SDB and snoring has multiple underlying mechanisms but often the common 
pathway is excessive loss of muscle tone in the throat and pharynx. These patients may be amenable to upper 
airway muscle training exercises using neuromuscular stimulation techniques. Over the last decade, there have 
been several publications on the use of upper airway training exercises and electrical neurostimulation of the 
upper airway for treatment of Snoring and OSA. Based on this background, we seek to test the hypothesis that 
daytime upper airway tongue muscle training using transoral surface neuromuscular electrical stimulation 
(SnooZeal Device) may have benefits to patients with Simple Snoring. 
 
6. 
SPECIFIC AIMS 
 
Primary Objective:  
Assess the efficacy of daytime trans-oral neuromuscular stimulation training on nocturnal snoring. 
 
Secondary Objectives:  
Assess the efficacy of daytime trans-oral daytime neuromuscular stimulation training on sleep quality and its 
safety. 
 
Primary Endpoint: 
A. Reduction of 20 % in the percentage of time spent snoring at levels greater than 40 dB. This will be 
achieved using WatchPat (510K - K161579) sleep studies 
B. Reduction of 40% in bed partner VAS assessment of snoring.  
 
Secondary Endpoints: 
A. Reduction in the Epworth Sleepiness Scale (validated hypersomnolence questionnaire) and Pittsburgh 
Sleep Index (validated sleep quality questionnaire with 7 domains). 
B. Assess safety of device (record and investigate adverse events, oral status and monitor device integrity 
through use) 
 
7. 
BACKGROUND AND SIGNIFICANCE 
Forty five percent of the male population snore, 25% habitually (daily). Sleep disordered breathing (SDB) 
(partial or total obstruction of the upper airway during sleep) is a spectrum of conditions (Fig 1) ranging from 
simple snoring to obstructive sleep apnea-hypopnea syndrome (OSAHS)1. The latter affects at least 4-6% of the 
population and is associated with increased incidence of hypertension, cardiac (heart attacks) and cerebral 
events (strokes). Although the gold standard of treatment for OSAHS is Continuous Positive Airway Pressure 
(CPAP), a variety of treatments are offered for simple snoring.  

 
 
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Figure 1: spectrum of sleep disordered related breathing ranging from simple snoring to severe obstructive 
sleep apnea syndrome (OSAHS: obstructive sleep apnea hypopnea syndrome, CPAP: continuous positive 
airway pressure) 
Although there are several lifestyle practices associated with snoring (smoking, obesity, drinking etc.), a 
significant proportion of individuals may snore despite not being associated with these. 
The most notable change that occurs in the physiology of humans during sleep is the reduction in the tone of 
the muscles and increased collapsibility of the throat (pharynx) and tongue. Notably, there is evidence to show 
that the collapsibility is significantly higher in patients who obstruct (OSAHS) and marginally higher in 
patients who snore (simple snoring) when compared to individuals who don’t snore (Fig 2)2. As demonstrated 
in the graph below, it has been shown that when compared to “normal” individuals, the breathing passage in 
snorers and sleep apnea individuals collapses at a positive rather than negative airway pressure. 
 
 
Figure 2: critical closing pressure in healthy subjects, snorers and patients with OSA (SDB-1 = snorers, SDB-2 
= Sleep Apnea), (according to Isono et al. 2) 
Research has demonstrated that increasing the pharyngeal muscle activity or tone, reduces the collapsibility of 
the airway as demonstrated by the graphs below (Figure 3). It is the reduction of throat/pharynx/tongue muscle 
tone that leads to this partial or complete obstruction. 

 
 
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Figure 3: Upper airway collapsibility and critical closing pressure in sleeping individuals (according to 
Schwartz et al.3) 
Several studies have shown that implanting electrical nerve stimulators (for the tongue and limited numbers for 
diaphragm) are effective in treatment of OSA. However, these stimulators involve operations and implantation 
of the device 4,5,6,7. Furthermore, studies involving apnea-triggered nocturnal stimulation reportedly disturb the 
patient sleep by arousals due to the electrical stimulation7. Also, similar to implanted pacemakers, there are 
multiple maintenance and logistic complications (battery replacement, unable to be in electromagnetic fields, 
cannot have other external electrical circuits attached, detected by external detection devices like airport 
security etc. etc.).  
There is a considerable body of knowledge, literature and evidence to state that use of transcutaneous electrical 
stimulation in paralyzed or inactive limbs (muscles with low or absent muscle tone) significantly improves 
muscle power and tone recovery8. Considering the muscles of the throat, pharynx and tongue are of the same 
muscle type as of the limbs (skeletal muscle), the hypothesis is electrical stimulation of the pharyngeal and 
tongue muscles would lead to a similar effect of increased resting muscle tone and muscle tone during sleep.  
Studies show that training the upper airway muscles either by playing a wind instrument (didgeridoo)9 or 
oropharyngeal exercises10,11,16 can ameliorate moderate OSA and snoring. A recent meta-analysis demonstrated 
that oropharyngeal exercises provide a reduction in apnea-hypopnea index (AHI) of 50% in adults and 
decreases snoring12. Oropharyngeal exercises are, therefore, a viable option to treat patients suffering from 
snoring and OSA. The presumption is that these changes are due to improvement in pharyngeal muscle tone.  
In a placebo controlled randomized study of tongue stimulation for OSA, although the OSA index did not 
significantly improve, there was a significant reduction in the snoring13. The number of snoring epochs 
decreased in the training group (baseline 63.9 ± 23.1 epochs per hour versus 47.5 ± 31.2; P < .05).  
Unlike the above-mentioned study, the SnooZeal device uses an entirely intra-oral stimulation device with an 
aim of reducing snoring in individuals with primary snoring. The mouth piece will be placed with two 
electrodes below and two above the tongue for muscle stimulation, with no transcutaneous component as in the 
previous studies.  

 
 
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A preliminary study with this trial product has been undertaken in 27 patients in Germany14. SnooZeal device 
was used twice a day for 20 minutes each time during the 6 week training period. The study showed that the 
mean snoring reduced from 6.4 to 3.1 (p=0.001) on bed partner Visual analogue score rating of snoring ((6.4 to 
2.7 in the primary snoring subgroup (p=0.001) versus a drop from 6.6 to 3.6 in the mild OSA subgroup 
(p=0.001)). There was a statistically significant improvement in 2 of 7 components of the Pittsburgh Sleep 
Questionnaire inventory supporting an improvement the snorer’s sleep quality with the use of the device. This 
study has been accepted for presentation and subsequent publication in Chest 2018. 
 
8. 
PROGRESS REPORT 
N/A 
 
9. 
RESEARCH DESIGN AND METHODS 
 
Introduction to device 
 
Indications: The Snoozeal transoral neurostimulation device is a prescription only, home use device. Its primary 
indication is for use in primary snoring. 
 
The TMS system is to be a reusable device that produces muscular stimulation via electrodes connected to the 
tongue muscles. It is to be considered a single medical device with three components; one controller, a washable 
electrode mouthpiece, and a remote control/mobile application (Figure 4).  
 
Figure 4. SnooZeal transoral neurostimulation device. 
 
The mouthpiece is connected to the control unit via a USB port and Bluetooth connection is established between 
the control unit and remote control/app. This allows the remote control/app control over the current level and 
on/off functionality of the control unit and mouth piece. 
 
The mouthpiece is placed in the mouth, with two electrodes located above and two electrodes below the tongue. 
The therapy consists of a series of pulse bursts with the basic characteristic of 6 secs burst and 4 seconds rest. 
During the 20 mins therapy period the pulse frequency will change every 5 mins in a defined sequence (through 
3, 10, 20 and 3 Hz frequencies). The product is to be used once daily (20 min therapy session), during the day, 
for a period of six weeks to get the desired improvement. 
 
 

 
 
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Research Method:  
 
The study plans to investigate the change in snoring sound, sleep quality and the safe use of intraoral 
neuromuscular stimulation using SnooZeal device. After appropriate screening and assessment, the recruited 
participants will procced through three phases of the trial. The Pre-Trial phase collects data on the pretreatment 
state of the participant, after which they will enter the Therapy phase where they use the device once daily for a 
six week period whilst continuing to record the required data. The participant will stop using the device at the 
end of this stage and have a follow up phase for two weeks, during which trial indices will continue to be recorded. 
The trial period for each participant will be 10 weeks. 
 
A. Screening 
Participants will be identified from Queen’s Hospital, Barking, Havering and Redbridge NHS Trust. There will 
be a screening phone call to ensure suitability based on an inclusion criterion and offer first line information 
about the trial. If suitable, patients will be given a written information sheet and invited to undertake a 2 day 
home sleep study (using WatchPAT). If the average AHI from these 2 days is below 15/h, the participants will 
be invited for a clinical examination.  
 
B. Recruitment visit 
• Clinical airway examination by ENT surgeon (Appendix 5) 
• Review of inclusion and exclusion criteria (section 10) 
• Informed consent (Appendix 7) 
• Inclusion into trial 
 
C. Pre-therapy period (day -14 to -1): 
 
• Bed partner daily subjective assessment of snoring (Visual Analog Scale). Participant’s bed partner will 
be required to complete daily visual analogue scoring of the participant’s snoring, with 1 being “no 
snoring” and 10 being “intolerable snoring”.  
• Oral examination (Detailed examination by Dentists to document pretreatment oral state – Appendix 5) 
• Participant and bed partner to complete sleep quality questionnaires (Pittsburgh Sleep Quality Index, 
Epworth sleepiness score and subjective sleep quality questionnaire) on Day -1 (Appendix 4) 
 
 
D. Therapy phase (day 1-42) 
 
• Face-to-face meeting, instruction on use of the intraoral device 
• Participant to use the Snoozeal device for 20 minutes once daily   
• Bed partner daily subjective assessment of snoring (VAS) 
• Participant daily assessment of side effects/adverse events and time of use 
• Participant and bed partner to complete Sleep quality Questionnaires (Pittsburgh Sleep Quality Index, 
Epworth sleepiness score and subjective sleep quality questionnaire) at day 42 
• Weekly follow up phone call from research team to confirm compliance. Compliance will also be cross 
checked using the total time of use recorded by the device.  
 
 
E. End of Therapy Review (day 43 – 49) 
• Review of device integrity by visual inspection   

 
 
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• Oral examination (Detailed examination by Dentists to document pretreatment oral state – see 
examination record sheets – Appendix 5) 
• Repeat Sleep Study – 2 night sleep study with WatchPAT 
 
F. Follow Up phase (day 43-56) 
• Participant advised to stop using device 
• Bed partner daily subjective assessment of snoring (VAS) 
• Subject and bed partner to complete Sleep quality Questionnaires (Pittsburgh Sleep Quality Index, 
Epworth sleepiness score and subjective sleep quality questionnaire) at day 56 
 
G. Post Therapy Review (day 57) 
• Face-to-face meeting and feedback 
• Collection of participant data sheets 
• Participant subjective overall assessment  
 
Data Analysis 
 
The pre and post sleep studies will be performed using WatchPAT.  
Parameters recorded: saturation, AHI, snoring sound parameters.  
 
AHI will be identified and analyzed by WatchPAT data and software. The WatchPat is an approved FDA sleep 
study device with 510K - K161579.  Snoring will be quantified subjectively by both the bed partner using a 
visual analog score, and objectively during the home sleep study as frequency of snores (number of snores / 
hours of sleep) and % total sleep time spent snoring. Sleep quality will be quantified subjectively by PSQI 
score. Sleepiness will be quantified subjectively by ESS score. 
 
Snoring Sound 
 
1) Objective: WatchPat Sleep study: Comparative analysis of % total sleep time spent snoring will be 
undertaken between the 2 day sleep study pre and post therapy phase. To ensure consistency, the 
WatchPAT microphone will be placed in the same position, just below the suprasternal notch, in both 
pre and post sleep studies. 
2) VAS: Partner reported change will be assessed using VAS. Therapy efficacy will be based on statistical 
analysis of average VAS scores for the three periods – pre-therapy (2 weeks), therapy phase (last 2 
weeks) and follow up phase (2 weeks).  
Although data will be collected for the whole of the six-week therapy phase, comparative analysis will 
be limited to the last two weeks of the therapy phase to exclude any transitional changes. The six-week 
therapy stage data will undergo temporal analysis to establish if there is a progressive change in the 
indices measured.  
3) Number of nights sleeping together recorded in Subjective sleep quality questionnaire will be assessed 
for the pre-therapy, therapy phase and follow up phase. 
 
Sleep Quality 
 
1) Epworth sleepiness score will be assessed for both Snorer and Bed partner for the pre-therapy, therapy 
phase and follow up phase.  
2) Pittsburgh Sleep Quality Index will be assessed for both Snorer and Bed partner for the pre-therapy, 
therapy phase and follow up phase. 

 
 
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3) Subjective sleep quality questionnaire will be assessed for both Snorer and Bed partner for the pre-
therapy, therapy phase and follow up phase. 
  
See Appendix 1 for endpoint assessment and validation 
 
Safety 
 
1) Any side effects or adverse events to be recorded in research record sheets and will be collated for 
assessment 
2) Pre and post therapy WatchPat sleep studies will be assessed for change in parameters of saturation and 
AHI.  
3) The pre and post oral examination clinical sheets will be scrutinized for any change in oral status. 
 
  
Statistical Considerations 
 
Sample size: 50 participants  
 
Data will be analyzed based on two tailed paired t-test, with 80% power. P < 0.05 will be considered 
significant. Multiple regression analysis will be used to identify which of the following factors has an causal 
relationship with the outcome - age, sex, BMI, neck size, AHI group (<5 and 5-15) and clinical examination 
characteristics (Endoscopy staging, Muller Maneuver, Friedman Classification, Tonsil size) 
 
Power analysis:  
• AHI reduction >50% and AHI <10: sample size required 17, 
• VAS change of 40%, (i.e. average snoring score to drop from 6.4 to 3.8 on 10 point scale): sample size 
required 4. Standard deviations extrapolated from Verse et al.15. 
•  To calculate the required sample size for the paired observations of pre and post treatment for 
proportion of sleeping time snoring more than 40 dB; first the correlation between proportions before 
and after treatment was estimated by using provided pilot data. The required sample size of the patients 
with snoring more than 40 dB was then calculated such that the one-sided statistical test would be able 
to detect 20% reduction in snoring time from 50% to 30% with 80% power. (See Appendix 1 for 
validation of parameters) 
  
 
10. 
HUMAN SUBJECTS 
Subjects  
50 primary snorers (AHI <15/hr) will be recruited from Queen’s Hospital, Romford (Barking, Havering and 
Redbridge NHS Trust), UK.  
 
Inclusion criteria 
 
• Age 18 years and above (adult population) at entry into study 
• Subjects must have a live-in partner as the assessment includes partners report 
• More than six month history of habitual snoring (i.e. >5 days per week as reported by partner) 
 
Exclusion criteria 
 

 
 
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• BMI > 35 kg/m2 
• AHI >15/h, i.e. evidence of moderate to severe OSA from sleep study  
• ESS > 10 in participants with AHI 5-15/h (symptomatic mild sleep apnea should be treated with CPAP) 
• Symptomatic nasal pathology i.e. septal deviation, nasal polyposis or chronic rhinosinusitis 
• Tonsil Hypertrophy (Tonsil size – Grade 3 or greater) 
• Tongue or lip piercing  
• Pacemaker or implanted medical electrical devices 
• Previous oral surgery for snoring 
• Relevant facial skeletal abnormalities (i.e. syndromic facial deficiencies, severe micrognathia etc.) 
• Oral disease/conditions (see Appendix 3) 
• Any criteria that, in the opinion of the investigator, would make the participant unsuitable for the study 
due to inability to complete required study procedures 
 
11. 
RECRUITMENT AND PROCEDURES PREPARATORY TO RESEARCH 
Participants will be identified from the sleep clinic at the Department of Otorhinolaryngology, Head and Neck 
Surgery in Queen’s Hospital, Barking, Havering and Redbridge University Hospitals NHS Trust. Patients may 
be referred to this service from dental practices. 
 
Participants considered to be suitable for the study will be invited to undergo a 2 night sleep study, performed at 
home using a WatchPAT device, to determine average AHI. If the AHI is less than 15, the participant will be 
invited to attend a clinic assessment for upper airway and to undertake an oral assessment.  
 
If all inclusion criteria and none of the exclusion criteria are met, full informed consent will be taken by the Chief 
Investigator or a delegated member of the research team. 
 
Participants will be on the study for a total of 10 weeks. 
 
12. 
INFORMED CONSENT 
All informed consent is completely voluntary. Participants and their partners will be given full information 
regarding the study prior to obtaining consent. Participants will be given the written patient information pack 
and provided with the full details of the study and its purpose. Participants will be given more than 24 hours to 
consider their participation in the study and to ask any questions they may have. Participants will be assessed 
for capacity to consent during the consent process. If lack of capacity is deemed, these participants will not be 
considered for the study.  
 
13. 
ALTERNATIVES TO STUDY PARTICIPATION 
Participation will not alter or influence patient’s normal clinical treatment. Participants do not have to take part 
in the study and if they do decide to, they are able to withdraw at any point. 
 
14. 
POTENTIAL RISKS 
We believe that this study and the Snoozeal device to be low risk. The investigative tool, the WatchPAT, for the 
sleep study is routine practice undertaken by thousands of patients and has FDA approval (510K - K161579). The 
Snoozeal device has been used in a pilot study of 27 patients, which revealed no significant adverse events14. 
 
SnooZeal device: The pilot study of the SnooZeal device involved 27 patients who used the device twice daily 
(double the planned utilization in this trial). The only side effects were feeling tingling of the tongue for a short 
period (up to 5 minutes) after using the device, excessive saliva production and gum discomfort during use as 
shown in Table 2. As these symptoms were in keeping with anticipated effects of device use and were not 

 
 
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persistent, we consider this to be a non-significant risk device. The mouthpiece has been modified since the 
original trail to address any gum contact and discomfort. Compared to RCTs on snoring, quoted in the 
American Sleep medicine guideline (TheraSnoreTM), the Snoozeal device has less severe and less prevalent side 
effects. 
 
A full risk assessment can be found in the DFMEA. 
 
 
Sleep Study with WatchPAT: 
 
 Participants may experience poorer sleep quality and minor discomfort related to the use of the WatchPAT 
device due to the larger size (compared to a normal wrist watch) and finger probe. However, we are expecting 
the level of discomfort to be significantly less when compared with a laboratory based polysomnography. 
Hypoallergenic tape will be used to minimize risk of skin irritation. 
 
Data Handling: There is a risk of loss of subject confidentiality. This study will comply with the Data Protection 
Act 1998 and Caldicott Principles as laid out in the privacy and confidentially considerations below. 
 
Table 1: Side effects of the TheraSnoreTM appliance (Cooke ME, Battagel JM) 
 
Table 2: Side effects of the Snoozeal device 
Side Effect (n = 23) 
Non-advanced MAD 
Advanced MAD 
 
Side Effect (n = 27) 
Short term 
(%) 
Short 
term (%) 
Long 
term (%) 
Short 
term (%) 
Long term 
(%) 
 
Muscular discomfort 
39 
13 
74 
26 
 
Tingling sensation 
33 
Temporomandibular 
joint discomfort 
26 
9 
61 
22 
 
Excessive salivation 
26 
Abnormal bite on 
waking 
39 
9 
57 
17 
 
Gum discomfort 
19 
Excessive salivation 
65 
26 
65 
22 
 
Feeling of change in 
speech 
4 
Dry mouth 
21 
52 
26 
70 
 
 
 
15. RISK MANAGEMENT PROCEDURES AND ADEQUACY OF RESOURCES 
 
Research Ethics Committee (REC) review & reports 
Ethical approval for this study has been granted by Stanmore Research Ethics Committee (REC) using the 
Integrated Research Application System (IRAS project ID: 219271). All correspondence with the REC will be 
retained. The Chief Investigator (CI) will notify the REC at the end of the study. It is also the CI’s 
responsibility to produce the final report of the study with the results including any publication and submit to 
the REC.   
Safety reporting 

 
 
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All Adverse Events and Reactions will be logged in data sheet or reported to CI and have cause analysis and 
assessment performed. If the AE is not defined as serious, the AE will be recorded in the study documents and 
the participant followed up by the research team. The AE will be documented in the participants’ source 
documents. 
Adverse Events (AEs) - any untoward medical occurrence in a participant to whom an intervention has been 
administered, including occurrences which are not necessarily caused by or related to that intervention. An AE 
can therefore be any unfavourable or unintended sign (including an abnormal laboratory finding), symptom or 
disease temporally associated with study activities. 
Adverse Reaction (ARs) - any untoward and unintended response in a participant to an intervention.  All 
adverse events judged by either the reporting investigator or the sponsor as having a reasonable causal 
relationship to the intervention qualify as adverse reactions. The expression ‘reasonable causal relationship’ 
means in general that there is evidence or an argument to suggest a causal relationship. 
Should any events arise during a therapy session, the session should be terminated immediately. If this does not 
resolve the issue, the participant should contact the research team, or in case of emergency, seek urgent medical 
attention. 
Serious Adverse Events (SAEs) 
Serious Adverse Events (SAEs) that are considered to be ‘related’ and ‘unexpected’ will be reported to the 
sponsor within 24 hours of learning of the event, and to the REC within 15 days in line with the required 
timeframe using the form shown in Appendix 6. 
A serious adverse event (SAE) is defined as an untoward occurrence that: 
• 
Results in death, 
• 
Is life-threatening, 
• 
Requires hospitalization or prolongation of existing hospitalization, 
• 
Results in persistent or significant disability or incapacity, 
• 
Consists of a congenital anomaly or birth defect, or 
• 
Is otherwise considered medically significant by the investigator. 
SAEs will be reported to the REC where in the opinion of the Chief Investigator the event was serious and: 
• 
Related (it may have resulted from administration of any of the research interventions), and 
• 
Unexpected (the type of event is not listed in the protocol or other Reference Safety Information as an 
expected occurrence). 
 
Device Defects 
 
Should an issue arise with the device, either mechanical or software related, participants are advised to contact 
the study team for troubleshooting advice. Should this occur during a therapy session, participants will be told 
to discontinue use immediately. If the error cannot be fixed through guided troubleshooting, the device will be 
replaced (at no cost to the participant). The defective device will be returned to the sponsor and sent to the 
manufacturer to undertake route cause analysis. 

 
 
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Protocol compliance  
Any accidental protocol deviations that occur will be documented and reported to the Chief Investigator and 
Sponsor immediately. 
 
16. PRIVACY AND CONFIDENTIALITY CONSIDERATIONS INCLUDING DATA ACCESS AND MANAGEMENT 
For this research, only the direct healthcare team has access to participant’s medical records. All collected data 
will be stored on NHS computers. Manual files will be kept safe within a locked cupboard in a coded room in the 
hospital office.   
The manual files of this study including completed consent forms, questionnaires and pro forma will be kept in 
a locked cupboard of a coded room in the ENT outpatient department in Queen's Hospital, where medical notes 
are kept. Only the healthcare team within the department has access to the room.  
All electronic data will be password protected and stored on a NHS computer in the ENT outpatients department 
in Queen's Hospital under personal logins of the research team. Therefore, no one else apart from the direct 
research team and the health care team will have access to the data. 
Personal data will be regarded as strictly confidential. This study will comply with the Data Protection Act 1998 
and Caldicott Principles. Action will be taken to ensure research team who will be handling the patient identifiable 
information are made fully aware of their responsibilities and obligations to respect patient confidentiality. All 
research team members are required to adhered to Trust/ University codes of conduct.  
The confidentiality is ensured through anonymization of data. The Trial register will allocate a Trial Number 
(e.g. SN001) which will be the only data associated with the patient collected data. Presentation of results will 
not include any subject identifiable details. Written reports of the study will include only anonymized data. 
Throughout the study, only the direct health care team who are also the research team members, which includes 
the Chief Investigator, Professor Bhik Kotecha will have access to the participants' personal data during the study.  
Local research NHS Trust R&D personnel may require access to study records for the purpose of inspection 
and/or audit. Patient will be asked to consent to this on the consent form. 
The data generated will be analyzed within Queen's Hospital, Romford. Only anonymized data will be available 
outside the hospital. 
 
17. POTENTIAL BENEFITS 
It is anticipated that the participant will experience improvement in snoring and sleep quality. They can continue 
to use the device if they choose to after the completion of the study and can participate in on going Post Market 
Surveillance. They can also be considered for other treatment modalities post completion of trial if appropriate. 
 
18. RISK/BENEFIT RATIO 
Due to the low risk nature and transient use of the device there is minimal risk to participants in this study. This 
device is the only one of its kind that aims to combat the cause of snoring, rather than merely treating the 
symptom, therefore we feel the benefits far out way the risks.   
 
19. EXPENSE TO PARTICIPANT 

 
 
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There will be no cost to the subject for participating in this study. All the tests and procedures that will be done for 
this research will be paid for by study funds.  
20. COMPENSATION FOR PARTICIPATION 
Participants will be reimbursed for their time and any travel costs with a flat fee of £500. 
 
21. PRIVILEGES/CERTIFICATIONS/LICENSES AND RESEARCH TEAM RESPONSIBILITIES 
All physicians performing physical exams and taking medical histories are GMC registered and able to practice in 
the UK.   
  
• Prof Bhik Kotecha is an ENT consultant at Queen’s Hospital, Romford and has worked in the field for 
over 20 years. He will be the PI of this study. 
• Karon Thurgood is an ENT nurse at Queen’s Hospital, Romford who leads the ENT and maxilla-facial 
out-patients departments. She will assist Prof Kotecha in the review and recruitment of participants. 
• Gurs Selma is a qualified dentist with extensive experience in dental implant surgery, he will be 
performing dental examinations before and after device therapy period. 
 
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K, Stuck BA, Maurer JT. HNO. 2003;51(12):966-70 
16. Physiotherapy in obstructive sleep apnea syndrome: preliminary results T. Lequeux Æ G. Chantrain Æ M. 
Bonnand A. J. Chelle Æ M. P. Thill Eur Arch Otorhinolaryngol 2005,262: 501–503 
 
 
23. FUNDING SUPPORT FOR THIS STUDY 
SnooZeal 
 
24. BIOLOGICAL MATERIALS TRANSFER AGREEMENT 
NA 
25. INVESTIGATIONAL DRUG FACT SHEET AND IND/IDE HOLDER 
NA 
26. IMPACT ON STAFF 
NA 
27. CONFLICT OF INTEREST 
The CI and the research team do not have any financial interests or other conflicts related to this study.  
 
This protocol was written by Professor Anshul Sama, who is an expert from SnooZeal Ltd. (sponsor).  
 
The protocol has been reviewed by the Chief investigator, Professor Bhik Kotecha, who is an independent 
expert in the field of Sleep Surgery based at the institution of the study.  
 
28. SUPPLEMENTAL INSTRUCTIONS FOR CANCER-RELATED STUDIES 
NA 
29. OTHER APPROVALS/REGULATED MATERIALS 
NA 
30. PROCEDURES FOR SURROGATE CONSENT AND/OR DECISIONAL CAPACITY ASSESSMENT 
NA