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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03222193
Other study ID # TRP-S-001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 16, 2017
Est. completion date June 15, 2019

Study information

Verified date May 2018
Source Tongue Laboratory
Contact Filip Bochnícek, MuDr
Phone +420 603 198 692
Email fbochnicek@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 35
Est. completion date June 15, 2019
Est. primary completion date December 15, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
TRP
3 months of TRP tongue retraining

Locations

Country Name City State
Czechia Poliklinika Šustova 1930/2 Praha 4

Sponsors (1)

Lead Sponsor Collaborator
Tongue Laboratory

Country where clinical trial is conducted

Czechia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Snore Index number of snores >36 dB per hour of sleep by BresoDx 3 months
Secondary Mean sound of snoring/night (dB), in supine, non-supine and both positions by BresoDx 3 months
Secondary Maximum sound of snoring/night (dB), in supine, non-supine and both positions by BresoDx 3 months
Secondary Sleep time Total sleep time (h), in supine, non-supine and both positions by BresoDx 3 months
Secondary Apnoea Hypopnea Index (AHI) Number of apnea/hypopnea per hour of sleep, in supine, non-supine and both positions by BresoDx 3 months
Secondary Orofacial functional score (NOT-S questionnaire) Using NOT-S questionnaire 3 months
Secondary Tongue Endurance score Using IOPI medical device 3 months
Secondary Quality of sleep Using Spiegel questionnaire 3 months
Secondary Comfort / Safety Using homemade questionnaire relative to TRP snorless TM 3 months
Secondary Nasal patency Measure of the Peak Nasal Inspiratory Flow by In-check PNIF meter 3 months
Secondary Treatment compliance Using the The TheraMon® temperature micro sensor 3 months
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