Snoring
Conditions
Keywords
Medical device, Retraining, Snoring, TRP, Tongue
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.
Interventions
DEVICETRP
3 months of TRP tongue retraining
Sponsors
Tongue Laboratory
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Snore Index | 3 months | number of snores \>36 dB per hour of sleep by BresoDx |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum sound of snoring/night | 3 months | (dB), in supine, non-supine and both positions by BresoDx |
| Sleep time | 3 months | Total sleep time (h), in supine, non-supine and both positions by BresoDx |
| Apnoea Hypopnea Index | 3 months | (AHI) Number of apnea/hypopnea per hour of sleep, in supine, non-supine and both positions by BresoDx |
| Orofacial functional score (NOT-S questionnaire) | 3 months | Using NOT-S questionnaire |
| Mean sound of snoring/night | 3 months | (dB), in supine, non-supine and both positions by BresoDx |
| Quality of sleep | 3 months | Using Spiegel questionnaire |
| Comfort / Safety | 3 months | Using homemade questionnaire relative to TRP snorless TM |
| Nasal patency | 3 months | Measure of the Peak Nasal Inspiratory Flow by In-check PNIF meter |
| Treatment compliance | 3 months | Using the The TheraMon® temperature micro sensor |
| Tongue Endurance score | 3 months | Using IOPI medical device |
Countries
Czechia
Contacts
Primary ContactFilip Bochníček, MuDr
Outcome results
None listed