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

NCT ID: NCT03222193

Last Updated: 2018-05-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-16
• Study Completion Date: 2019-06-15

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.

Conditions

Snoring

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TRP group

Snoring subjects treated with the Tongue Right Positioner (TRP) medical device

Group Type: EXPERIMENTAL

TRP

Intervention Type: DEVICE

3 months of TRP tongue retraining

Interventions

TRP

3 months of TRP tongue retraining

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tongue Laboratory

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Poliklinika Šustova 1930/2

Prague, , Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Filip Bochníček, MuDr

Role: CONTACT

fbochnicek@gmail.com

+420 603 198 692

Facility Contacts

Filip Bochníček, MuDr

Role: primary

Other Identifiers

TRP-S-001

Identifier Type: -

Identifier Source: org_study_id