Efficacy Study of the Medical Device TRP Snorless™ in the... | NCT03222193

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

NCT03222193

Sponsor

Tongue Laboratory

Status

Unknown status

Last Update Posted

May 11, 2018Actual

Enrollment

35Estimated

Phase

Not Applicable

Conditions

Snoring

Interventions

Countries

Czechia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 16, 2017Actual

Primary Completion Date

Dec 15, 2018Estimated

Completion Date

Jun 15, 2019Estimated

First Submitted Date

Jul 17, 2017

First Submission Date that Met QC Criteria

Jul 17, 2017

First Posted Date

Jul 19, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 9, 2018

Last Update Posted Date

May 11, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

35Estimated

Label	Type	Description	Intervention Names
TRP group	Experimental	Snoring subjects treated with the Tongue Right Positioner (TRP) medical device	Device: TRP

Name	Type	Description	Arm Group Labels	Other Names
TRP	Device	3 months of TRP tongue retraining	TRP group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D012135	Respiratory Sounds
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms