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

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.

Study Overview

• Status: Unknown
• Conditions: Snoring
• Intervention / Treatment: Device: TRP

• Study Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Praha 4, Czechia, 149 00
    • Recruiting
    • Poliklinika Šustova 1930/2
    • Contact: Filip Bochníček, MuDr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TRP group; Snoring subjects treated with the Tongue Right Positioner (TRP) medical device	Device: TRP; 3 months of TRP tongue retraining

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Snore Index	number of snores >36 dB per hour of sleep by BresoDx	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean sound of snoring/night	(dB), in supine, non-supine and both positions by BresoDx	3 months
Maximum sound of snoring/night	(dB), in supine, non-supine and both positions by BresoDx	3 months
Sleep time	Total sleep time (h), in supine, non-supine and both positions by BresoDx	3 months
Apnoea Hypopnea Index	(AHI) Number of apnea/hypopnea per hour of sleep, in supine, non-supine and both positions by BresoDx	3 months
Orofacial functional score (NOT-S questionnaire)	Using NOT-S questionnaire	3 months
Tongue Endurance score	Using IOPI medical device	3 months
Quality of sleep	Using Spiegel questionnaire	3 months
Comfort / Safety	Using homemade questionnaire relative to TRP snorless TM	3 months
Nasal patency	Measure of the Peak Nasal Inspiratory Flow by In-check PNIF meter	3 months
Treatment compliance	Using the The TheraMon® temperature micro sensor	3 months

Collaborators and Investigators

• Sponsor: Tongue Laboratory

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2017
• Primary Completion (Anticipated): December 15, 2018
• Study Completion (Anticipated): June 15, 2019

Study Registration Dates

• First Submitted: July 17, 2017
• First Submitted That Met QC Criteria: July 17, 2017
• First Posted (Actual): July 19, 2017

Study Record Updates

• Last Update Posted (Actual): May 11, 2018
• Last Update Submitted That Met QC Criteria: May 9, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Tongue; Medical device; Snoring; TRP; Retraining
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Respiratory Sounds; Snoring
• Other Study ID Numbers: TRP-S-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No