SnoringSCOREDNCT03222193
Efficacy Study of the Medical Device TRP Snorless™ in the Treatment of Snoring
A study testing TRP in people with Snoring, run by Tongue Laboratory at 1 site in Czechia.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Snoring
- What is being tested?
- TRP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteCzechia
- Study dates
- 16 Jun 2017to 15 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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 locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Poliklinika Šustova 1930/2
Prague, 149 00
Filip Bochníček, MuDr
About this study
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.
- Conditions
- Snoring
- Being tested
- TRP
- Keywords
- Medical device, Retraining, Snoring, TRP, Tongue
- Medical subject headings
- Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRPDevice
3 months of TRP tongue retraining
| Study group | Role | What they receive |
|---|---|---|
| TRP group | Experimental | Snoring subjects treated with the Tongue Right Positioner (TRP) medical device Receives: Device: TRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Snore Index
number of snores >36 dB per hour of sleep by BresoDx
Measured: 3 months
Secondary outcomes (10)
Mean sound of snoring/night
(dB), in supine, non-supine and both positions by BresoDx
Measured: 3 months
Maximum sound of snoring/night
(dB), in supine, non-supine and both positions by BresoDx
Measured: 3 months
Sleep time
Total sleep time (h), in supine, non-supine and both positions by BresoDx
Measured: 3 months
Apnoea Hypopnea Index
(AHI) Number of apnea/hypopnea per hour of sleep, in supine, non-supine and both positions by BresoDx
Measured: 3 months
Orofacial functional score (NOT-S questionnaire)
Using NOT-S questionnaire
Measured: 3 months
Tongue Endurance score
Using IOPI medical device
Measured: 3 months
Quality of sleep
Using Spiegel questionnaire
Measured: 3 months
Comfort / Safety
Using homemade questionnaire relative to TRP snorless TM
Measured: 3 months
Nasal patency
Measure of the Peak Nasal Inspiratory Flow by In-check PNIF meter
Measured: 3 months
Treatment compliance
Using the The TheraMon® temperature micro sensor
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start16 Jun 2017
- Primary completion15 Dec 2018 (estimated)
- Study completion15 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SnoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongue Laboratory
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03222193
- Sponsor's protocol ID
- TRP-S-001
- Acronym
- SCORED
- Status last verified
- May 2018
- First submitted
- 17 Jul 2017
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Study of the Medical Device TRP Snorless™ in the Treatment of Snoring
- ClinicalTrials.gov ID
- NCT03222193
- Acronym / sponsor ID
- SCORED / TRP-S-001
- Conditions
- Snoring
- Keywords
- Medical device, Retraining, Snoring, TRP, Tongue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Tongue LaboratoryIndustry (pharma, biotech, devices)
- Study start
- 16 Jun 2017 (actual)
- Primary completion
- 15 Dec 2018 (estimated)
- Study completion
- 15 Jun 2019 (estimated)
- First posted
- 19 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TRP group | Experimental | Device: TRPSnoring subjects treated with the Tongue Right Positioner (TRP) medical device |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRP3 months of TRP tongue retraining | Device | TRP group |
Primary outcome
Snore Index
Time frame: 3 months
number of snores >36 dB per hour of sleep by BresoDx
10 secondary outcomes
Mean sound of snoring/night
Time frame: 3 months
Maximum sound of snoring/night
Time frame: 3 months
Sleep time
Time frame: 3 months
Apnoea Hypopnea Index
Time frame: 3 months
Orofacial functional score (NOT-S questionnaire)
Time frame: 3 months
Tongue Endurance score
Time frame: 3 months
Quality of sleep
Time frame: 3 months
Comfort / Safety
Time frame: 3 months
Nasal patency
Time frame: 3 months
Treatment compliance
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRP in people with Snoring, run by Tongue Laboratory at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Filip Bochníček, MuDr (+420 603 198 692, fbochnicek@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Snore Index (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.