Clinical trial NCT03222193: Efficacy Study of the Medical Device TRP Snorless™ in the Treatment of Snoring
Official title: Efficacy Study of the Medical Device TRP Snorless™ in the Treatment of Snoring
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Snoring
Keywords: Medical device
Retraining
Snoring
TRP
Tongue
Lead sponsor: Tongue Laboratory
Sponsor class: INDUSTRY
First posted: 2017-07-19
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Snore Index
timeFrame: 3 months
Secondary outcomes:
measure: Mean sound of snoring/night
timeFrame: 3 months
measure: Maximum sound of snoring/night
timeFrame: 3 months
measure: Sleep time
timeFrame: 3 months
measure: Apnoea Hypopnea Index
timeFrame: 3 months
measure: Orofacial functional score (NOT-S questionnaire)
timeFrame: 3 months
measure: Tongue Endurance score
timeFrame: 3 months
measure: Quality of sleep
timeFrame: 3 months
measure: Comfort / Safety
timeFrame: 3 months
measure: Nasal patency
timeFrame: 3 months
measure: Treatment compliance
timeFrame: 3 months
Other outcomes:
Locations:
city: Praha 4
country: Czechia
facility: Poliklinika Šustova 1930/2
Study officials:
References: