Efficacy Study of the Medical Device TRP Snorless™ in the Treatment of Snoring

Study Overview
=================
Brief Summary
-----------------
The Tongue Right Positioner (TRP Snorless™) is a medical device designed to restore physiological tongue positions when functioning or at rest and increase tongue muscles tone. Patient wears TRP Snorless™ daily at least 5 hours during night. Published data suggested that TRP Snorless™ increases oropharynx diameter and nasal patency, favouring airflow in upper airways. Independently of patient's adherence to daily myofascial exercises, the TRP Snorless™ treatment should increase tongue muscles' tone and decrease the risk of snoring during sleep.

Official Title
-----------------
Efficacy Study of the Medical Device TRP Snorless™ in the Treatment of Snoring

Conditions
-----------------
Snoring

Intervention / Treatment
-----------------
* Device: TRP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Man or woman ≥ 18 years and ≤ 65 years at the time of signing informed consent Listed as continuous snorer (snoring at least 4 nights/week) Answer Extremely loud or very loud to question 1 of SBPS at screening Answer very severe or severe to question 2 of SBPS at screening Answer extremely or quite a bit to question 3 of SBPS at screening Dated and signed informed consent BMI ≤ 35 Exclusion Criteria: Severe Mandibular retrognathia and micrognathia Narrow and deep palate (less than 3 cm wide) Lack of three consecutive teeth in the area of (15-16-17-18) or (25-26-27-28). Lingual or labial short frenulum (the tongue cannot reach the upper incisors when mouth can be opened for two fingers) Intolerable gag reflex Known nasal septal deviation Neck circumference > 46 cm Patient currently treated for OSA Patient with AHI≥30 events/hour or with AHI>15 and (SFI) Sleep Fragmentation Index > 20 Patient currently treated for central sleep apnoea Addiction to alcoholic beverages (5 drinks per day per NIAAA) Under constant pharmacological treatment for depression, anxiety, chronic pain, insomnia Hypertrophy of tonsils Macroglossia Hypertrophy of uvula Primary gastroesophageal reflux Any other pathology preventing subject from complying with the protocol Subject with recent oropharyngeal surgery or likely during the study Mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with study procedures Pregnancy Patient with severe Chronic Obstructive Pulmonary Disease Asthmatic patient under inhaled corticoid therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TRP group<br>Snoring subjects treated with the Tongue Right Positioner (TRP) medical device | Device: TRP<br>* 3 months of TRP tongue retraining<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Snore Index | number of snores >36 dB per hour of sleep by BresoDx | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean sound of snoring/night | (dB), in supine, non-supine and both positions by BresoDx | 3 months | 
| Maximum sound of snoring/night | (dB), in supine, non-supine and both positions by BresoDx | 3 months | 
| Sleep time | Total sleep time (h), in supine, non-supine and both positions by BresoDx | 3 months | 
| Apnoea Hypopnea Index | (AHI) Number of apnea/hypopnea per hour of sleep, in supine, non-supine and both positions by BresoDx | 3 months | 
| Orofacial functional score (NOT-S questionnaire) | Using NOT-S questionnaire | 3 months | 
| Tongue Endurance score | Using IOPI medical device | 3 months | 
| Quality of sleep | Using Spiegel questionnaire | 3 months | 
| Comfort / Safety | Using homemade questionnaire relative to TRP snorless TM | 3 months | 
| Nasal patency | Measure of the Peak Nasal Inspiratory Flow by In-check PNIF meter | 3 months | 
| Treatment compliance | Using the The TheraMon® temperature micro sensor | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TRP, Tongue, Medical device, Retraining, Snoring