Efficacy Study of the Medical Device TRP Snorless™ in the Treatment of Snoring (SCORED)
Primary Purpose
Snoring
Status
Unknown status
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
TRP
Sponsored by
About this trial
This is an interventional treatment trial for Snoring focused on measuring Medical device, Retraining, Snoring, TRP, Tongue
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
Sites / Locations
- Poliklinika Šustova 1930/2Recruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TRP group
Arm Description
Snoring subjects treated with the Tongue Right Positioner (TRP) medical device
Outcomes
Primary Outcome Measures
Snore Index
number of snores >36 dB per hour of sleep by BresoDx
Secondary Outcome Measures
Mean sound of snoring/night
(dB), in supine, non-supine and both positions by BresoDx
Maximum sound of snoring/night
(dB), in supine, non-supine and both positions by BresoDx
Sleep time
Total sleep time (h), in supine, non-supine and both positions by BresoDx
Apnoea Hypopnea Index
(AHI) Number of apnea/hypopnea per hour of sleep, in supine, non-supine and both positions by BresoDx
Orofacial functional score (NOT-S questionnaire)
Using NOT-S questionnaire
Tongue Endurance score
Using IOPI medical device
Quality of sleep
Using Spiegel questionnaire
Comfort / Safety
Using homemade questionnaire relative to TRP snorless TM
Nasal patency
Measure of the Peak Nasal Inspiratory Flow by In-check PNIF meter
Treatment compliance
Using the The TheraMon® temperature micro sensor
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03222193
Brief Title
Efficacy Study of the Medical Device TRP Snorless™ in the Treatment of Snoring
Acronym
SCORED
Official Title
Efficacy Study of the Medical Device TRP Snorless™ in the Treatment of Snoring
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 16, 2017 (Actual)
Primary Completion Date
December 15, 2018 (Anticipated)
Study Completion Date
June 15, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tongue Laboratory
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Snoring
Keywords
Medical device, Retraining, Snoring, TRP, Tongue
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TRP group
Arm Type
Experimental
Arm Description
Snoring subjects treated with the Tongue Right Positioner (TRP) medical device
Intervention Type
Device
Intervention Name(s)
TRP
Intervention Description
3 months of TRP tongue retraining
Primary Outcome Measure Information:
Title
Snore Index
Description
number of snores >36 dB per hour of sleep by BresoDx
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Mean sound of snoring/night
Description
(dB), in supine, non-supine and both positions by BresoDx
Time Frame
3 months
Title
Maximum sound of snoring/night
Description
(dB), in supine, non-supine and both positions by BresoDx
Time Frame
3 months
Title
Sleep time
Description
Total sleep time (h), in supine, non-supine and both positions by BresoDx
Time Frame
3 months
Title
Apnoea Hypopnea Index
Description
(AHI) Number of apnea/hypopnea per hour of sleep, in supine, non-supine and both positions by BresoDx
Time Frame
3 months
Title
Orofacial functional score (NOT-S questionnaire)
Description
Using NOT-S questionnaire
Time Frame
3 months
Title
Tongue Endurance score
Description
Using IOPI medical device
Time Frame
3 months
Title
Quality of sleep
Description
Using Spiegel questionnaire
Time Frame
3 months
Title
Comfort / Safety
Description
Using homemade questionnaire relative to TRP snorless TM
Time Frame
3 months
Title
Nasal patency
Description
Measure of the Peak Nasal Inspiratory Flow by In-check PNIF meter
Time Frame
3 months
Title
Treatment compliance
Description
Using the The TheraMon® temperature micro sensor
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Filip Bochníček, MuDr
Phone
+420 603 198 692
Email
fbochnicek@gmail.com
Facility Information:
Facility Name
Poliklinika Šustova 1930/2
City
Praha 4
ZIP/Postal Code
149 00
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Filip Bochníček, MuDr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy Study of the Medical Device TRP Snorless™ in the Treatment of Snoring
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