Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2026-02-22 @ 4:54 PM
Study NCT ID:
NCT03222193
Status:
UNKNOWN
Last Update Posted:
2018-05-11
First Post:
2017-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of the Medical Device TRP Snorless™ in the Treatment of Snoring
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012913', 'term': 'Snoring'}], 'ancestors': [{'id': 'D012135', 'term': 'Respiratory Sounds'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 35}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-06-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2019-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-09', 'studyFirstSubmitDate': '2017-07-17', 'studyFirstSubmitQcDate': '2017-07-17', 'lastUpdatePostDateStruct': {'date': '2018-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Snore Index', 'timeFrame': '3 months', 'description': 'number of snores \\>36 dB per hour of sleep by BresoDx'}], 'secondaryOutcomes': [{'measure': 'Mean sound of snoring/night', 'timeFrame': '3 months', 'description': '(dB), in supine, non-supine and both positions by BresoDx'}, {'measure': 'Maximum sound of snoring/night', 'timeFrame': '3 months', 'description': '(dB), in supine, non-supine and both positions by BresoDx'}, {'measure': 'Sleep time', 'timeFrame': '3 months', 'description': 'Total sleep time (h), in supine, non-supine and both positions by BresoDx'}, {'measure': 'Apnoea Hypopnea Index', 'timeFrame': '3 months', 'description': '(AHI) Number of apnea/hypopnea per hour of sleep, in supine, non-supine and both positions by BresoDx'}, {'measure': 'Orofacial functional score (NOT-S questionnaire)', 'timeFrame': '3 months', 'description': 'Using NOT-S questionnaire'}, {'measure': 'Tongue Endurance score', 'timeFrame': '3 months', 'description': 'Using IOPI medical device'}, {'measure': 'Quality of sleep', 'timeFrame': '3 months', 'description': 'Using Spiegel questionnaire'}, {'measure': 'Comfort / Safety', 'timeFrame': '3 months', 'description': 'Using homemade questionnaire relative to TRP snorless TM'}, {'measure': 'Nasal patency', 'timeFrame': '3 months', 'description': 'Measure of the Peak Nasal Inspiratory Flow by In-check PNIF meter'}, {'measure': 'Treatment compliance', 'timeFrame': '3 months', 'description': 'Using the The TheraMon® temperature micro sensor'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Medical device', 'Retraining', 'Snoring', 'TRP', 'Tongue'], 'conditions': ['Snoring']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Man or woman ≥ 18 years and ≤ 65 years at the time of signing informed consent\n* Listed as continuous snorer (snoring at least 4 nights/week)\n* Answer "Extremely loud" or "very loud" to question 1 of SBPS at screening\n* Answer "very severe" or "severe" to question 2 of SBPS at screening\n* Answer "extremely" or "quite a bit" to question 3 of SBPS at screening\n* Dated and signed informed consent\n* BMI ≤ 35\n\nExclusion Criteria:\n\n* Severe Mandibular retrognathia and micrognathia\n* Narrow and deep palate (less than 3 cm wide)\n* Lack of three consecutive teeth in the area of (15-16-17-18) or (25-26-27-28).\n* Lingual or labial short frenulum (the tongue cannot reach the upper incisors when mouth can be opened for two fingers)\n* Intolerable gag reflex\n* Known nasal septal deviation\n* Neck circumference \\> 46 cm\n* Patient currently treated for OSA\n* Patient with AHI≥30 events/hour or with AHI\\>15 and (SFI) Sleep Fragmentation Index \\> 20\n* Patient currently treated for central sleep apnoea\n* Addiction to alcoholic beverages (5 drinks per day per NIAAA)\n* Under constant pharmacological treatment for depression, anxiety, chronic pain, insomnia\n* Hypertrophy of tonsils\n* Macroglossia\n* Hypertrophy of uvula\n* Primary gastroesophageal reflux\n* Any other pathology preventing subject from complying with the protocol\n* Subject with recent oropharyngeal surgery or likely during the study\n* Mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with study procedures\n* Pregnancy\n* Patient with severe Chronic Obstructive Pulmonary Disease\n* Asthmatic patient under inhaled corticoid therapy'}, 'identificationModule': {'nctId': 'NCT03222193', 'acronym': 'SCORED', 'briefTitle': 'Efficacy Study of the Medical Device TRP Snorless™ in the Treatment of Snoring', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tongue Laboratory'}, 'officialTitle': 'Efficacy Study of the Medical Device TRP Snorless™ in the Treatment of Snoring', 'orgStudyIdInfo': {'id': 'TRP-S-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TRP group', 'description': 'Snoring subjects treated with the Tongue Right Positioner (TRP) medical device', 'interventionNames': ['Device: TRP']}], 'interventions': [{'name': 'TRP', 'type': 'DEVICE', 'description': '3 months of TRP tongue retraining', 'armGroupLabels': ['TRP group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '149 00', 'city': 'Prague', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Filip Bochníček, MuDr', 'role': 'CONTACT'}], 'facility': 'Poliklinika Šustova 1930/2', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}], 'centralContacts': [{'name': 'Filip Bochníček, MuDr', 'role': 'CONTACT', 'email': 'fbochnicek@gmail.com', 'phone': '+420 603 198 692'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tongue Laboratory', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}