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

NCT03222193 | Unknown

• 1 other identifier: TRP-S-001
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Keywords

Medical device; Retraining; Snoring; TRP; Tongue

Outcome Measures

Primary Outcomes (1)

• Snore Index

  number of snores \>36 dB per hour of sleep by BresoDx

  3 months

Secondary Outcomes (10)

• Mean sound of snoring/night

  3 months

• Maximum sound of snoring/night

  3 months

• Sleep time

  3 months

• Apnoea Hypopnea Index

  3 months

• Orofacial functional score (NOT-S questionnaire)

  3 months

Study Arms (1)

TRP group

EXPERIMENTAL

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

Device: TRP

Interventions

TRP DEVICE

3 months of TRP tongue retraining

TRP group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tongue Laboratory: lead

Study Sites (1)

Poliklinika Šustova 1930/2

Prague, 149 00, Czechia

RECRUITING

MeSH Terms

Conditions

Snoring

Condition Hierarchy (Ancestors)

Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Filip Bochníček, MuDr

CONTACT

+420 603 198 692; fbochnicek@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2017
• First Posted: July 19, 2017
• Study Start: June 16, 2017
• Primary Completion: December 15, 2018
• Study Completion: June 15, 2019
• Last Updated: May 11, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)