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

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

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.

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