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

Last updated: May 9, 2018
Sponsor: Tongue Laboratory
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sleep Disorders

Treatment

N/A

Clinical Study ID

NCT03222193
TRP-S-001
  • Ages 18-65
  • All Genders

Study 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

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

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 whenmouth 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 understandingof or compliance with study procedures

  • Pregnancy

  • Patient with severe Chronic Obstructive Pulmonary Disease

  • Asthmatic patient under inhaled corticoid therapy

Study Design

Total Participants: 35
Study Start date:
June 16, 2017
Estimated Completion Date:
June 15, 2019

Connect with a study center

  • Poliklinika Šustova 1930/2

    Praha 4, 149 00
    Czechia

    Active - Recruiting

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