Snoring Clinical Trial
— SCOREDOfficial title:
Efficacy Study of the Medical Device TRP Snorless™ in the Treatment of Snoring
NCT number | NCT03222193 |
Other study ID # | TRP-S-001 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 16, 2017 |
Est. completion date | June 15, 2019 |
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.
Status | Recruiting |
Enrollment | 35 |
Est. completion date | June 15, 2019 |
Est. primary completion date | December 15, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Czechia | Poliklinika Šustova 1930/2 | Praha 4 |
Lead Sponsor | Collaborator |
---|---|
Tongue Laboratory |
Czechia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Snore Index | number of snores >36 dB per hour of sleep by BresoDx | 3 months | |
Secondary | Mean sound of snoring/night | (dB), in supine, non-supine and both positions by BresoDx | 3 months | |
Secondary | Maximum sound of snoring/night | (dB), in supine, non-supine and both positions by BresoDx | 3 months | |
Secondary | Sleep time | Total sleep time (h), in supine, non-supine and both positions by BresoDx | 3 months | |
Secondary | Apnoea Hypopnea Index | (AHI) Number of apnea/hypopnea per hour of sleep, in supine, non-supine and both positions by BresoDx | 3 months | |
Secondary | Orofacial functional score (NOT-S questionnaire) | Using NOT-S questionnaire | 3 months | |
Secondary | Tongue Endurance score | Using IOPI medical device | 3 months | |
Secondary | Quality of sleep | Using Spiegel questionnaire | 3 months | |
Secondary | Comfort / Safety | Using homemade questionnaire relative to TRP snorless TM | 3 months | |
Secondary | Nasal patency | Measure of the Peak Nasal Inspiratory Flow by In-check PNIF meter | 3 months | |
Secondary | Treatment compliance | Using the The TheraMon® temperature micro sensor | 3 months |
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