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

Tongue Lab

Status

Unknown

Conditions

Snoring

Treatments

Device: TRP

Study type

Interventional

Funder types

Industry

Identifiers

NCT03222193

TRP-S-001

Details and patient eligibility

About

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.

Enrollment

35 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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