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

T

Tongue Lab

Status

Unknown

Conditions

Snoring

Treatments

Device: TRP

Study type

Interventional

Funder types

Industry

Identifiers

NCT03222193
TRP-S-001

Details and patient eligibility

About

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.

Enrollment

35 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

35 participants in 1 patient group

TRP group
Experimental group
Description:
Snoring subjects treated with the Tongue Right Positioner (TRP) medical device
Treatment:
Device: TRP

Trial contacts and locations

1

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Central trial contact

Filip Bochníček, MuDr

Data sourced from clinicaltrials.gov

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