Efficacy Study of the Medical Device TRP Snorless™ in the Treatment of Snoring
- Conditions
- Snoring
- Interventions
- Device: TRP
- Registration Number
- NCT03222193
- Lead Sponsor
- Tongue Laboratory
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 35
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TRP group TRP Snoring subjects treated with the Tongue Right Positioner (TRP) medical device
- Primary Outcome Measures
Name Time Method Snore Index 3 months number of snores \>36 dB per hour of sleep by BresoDx
- Secondary Outcome Measures
Name Time Method Sleep time 3 months Total sleep time (h), in supine, non-supine and both positions by BresoDx
Orofacial functional score (NOT-S questionnaire) 3 months Using NOT-S questionnaire
Tongue Endurance score 3 months Using IOPI medical device
Quality of sleep 3 months Using Spiegel questionnaire
Comfort / Safety 3 months Using homemade questionnaire relative to TRP snorless TM
Treatment compliance 3 months Using the The TheraMon® temperature micro sensor
Mean sound of snoring/night 3 months (dB), in supine, non-supine and both positions by BresoDx
Maximum sound of snoring/night 3 months (dB), in supine, non-supine and both positions by BresoDx
Nasal patency 3 months Measure of the Peak Nasal Inspiratory Flow by In-check PNIF meter
Apnoea Hypopnea Index 3 months (AHI) Number of apnea/hypopnea per hour of sleep, in supine, non-supine and both positions by BresoDx
Trial Locations
- Locations (1)
Poliklinika Šustova 1930/2
🇨🇿Praha 4, Czechia