Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 2:40 AM
Study NCT ID:
NCT07414420
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-18
First Post:
2026-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Dynamic Propulsion Appliance in Treatment of Patients With Obstructive Sleeping Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-13', 'studyFirstSubmitDate': '2026-02-09', 'studyFirstSubmitQcDate': '2026-02-09', 'lastUpdatePostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'jaw functional limitation skill', 'timeFrame': 'prior to the treatment and 3 months after the treatment initiation', 'description': 'monitoring the movement range of the lower jaw'}, {'measure': 'masticatory muscles sensitivity', 'timeFrame': 'prior to the treatment and 3 months after the treatment initiation', 'description': 'by the method of the palpation'}, {'measure': 'gingival index', 'timeFrame': 'prior to the treatment and 3 months after the treatment initiation', 'description': 'according to the Lou-Silness'}, {'measure': 'plaque index', 'timeFrame': 'prior to the treatment and 3 months after the treatment initiation', 'description': 'according to Silness-Lou'}, {'measure': 'bleeding on probing', 'timeFrame': 'prior to the treatment and 3 months after the treatment initiation', 'description': 'based on the number of bleeding spots around each tooth'}, {'measure': 'probing pocket depth', 'timeFrame': 'prior to the treatment and 3 months after the treatment initiation'}], 'primaryOutcomes': [{'measure': 'nasal airflow', 'timeFrame': 'prior to treatment and 3 months after the treatment initiation', 'description': 'measured by respiratory poligraphy (ml/min)'}, {'measure': 'oxygen saturation', 'timeFrame': 'prior to treatment and 3 months after start of the treatment', 'description': 'measured by respiratory poligraphy in the range 0-100%'}, {'measure': 'heart rate', 'timeFrame': 'prior to treatment and 3 months after treatment initiation', 'description': 'measured by respiratory poligraphy in the range 30 - 250 bpm'}, {'measure': 'nasal air pressure', 'timeFrame': 'prior to the treatment and 3 months after the treatment initiation', 'description': 'measured by respiratory poligraphy'}, {'measure': 'toracal and abdominal strain', 'timeFrame': 'prior to the treatment and 3 months after treatment initiation', 'description': 'measured by respiratory poligraphy'}, {'measure': 'audio recording of breathing and snoring', 'timeFrame': 'prior to the treatment and 3 months after treatment initiation', 'description': 'measured by respiratory poligraphy'}, {'measure': 'body posture and activity', 'timeFrame': 'prior to the treatment and 3 months after the treatment initiation', 'description': 'measured by pulmonary poligraphy'}], 'secondaryOutcomes': [{'measure': 'sleepness monitoring', 'timeFrame': 'prior to the treatment and 3 months after the treatment initiation', 'description': 'measured by Epworth Sleepness Scale (a self-administered, 8-question survey measuring daytime sleepiness by rating the likelihood of dozing in common, sedentary situations; scores range from 0-24, with higher numbers indicating excessive daytime sleepiness)'}, {'measure': 'snoring and breathing disruption during the sleep', 'timeFrame': 'prior to the treatment and 3 months after the treatment initiation', 'description': 'measured by Berlin Questionnaire (snoring intensity, frequency, and witnessed apnea - questions Nr. 1 to Nr. 5, a positive score indicates a high risk of OSA'}, {'measure': 'daily sleepiness monitoring', 'timeFrame': 'prior to the treatment and 3 months after the treatment initiation', 'description': 'measured by Berlin Questionnaire (daytime sleepiness, fatigue, or nodding off while driving - questions Nr. 6 to Nr. 9, positive score indicates high risk of OSA)'}, {'measure': 'presence of hypertension and/or obesity', 'timeFrame': 'prior to the treatment and 3 months after the treatment initiation', 'description': 'measured by Berlin Questionnaire (History of high blood pressure (\\>140/90) or Body Mass Index (BMI) \\>30 kg/m2 - question 10)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obstructive sleep apnea, oral apparatus'], 'conditions': ['Obstructive Sleep Apnea (OSA)']}, 'descriptionModule': {'briefSummary': 'Obstructive Sleep Apnea (OSA) is one of the most prevalent sleep disorders, affecting nearly one billion people worldwide. It is characterized by repeated episodes of complete (apnea) or partial (hypopnea) obstruction of the upper airway during sleep, leading to snoring, excessive daytime sleepiness, insomnia, morning headaches, nocturia, behavioral changes, reduced concentration, and serious cardiovascular and metabolic complications such as insulin resistance, type II diabetes, and metabolic syndrome. During the night, patients may experience up to a hundred apnea or hypopnea events lasting from 10 to 120 seconds. Therapy for OSA depends on its severity, defined by five or more obstructive events per hour of sleep. Over the past decade and a half, oral appliances (OAs) have become the treatment of choice for mild to moderate forms of OSA due to their efficacy and comfort. For this purpose, the DYNAMIC PROPULSION ORAL APPLIANCE (DPOA) has been designed with a mechanism that provides controlled, gentle, gradual and automatic mandible movement in propulsion during sleep. Unlike conventional OAs that fix the mandible in only one propulsive position, causing stress to orofacial complex and upper airway structures such as masticatory muscles and the temporomandibular joints, the DPOA provides gradual, automatic mandibular movement to the previously determined propulsive position. This gradual adaptation minimizes stress, reduces side effects, and enhances treatment success. In that way, the DPOA enables complete functional adaptation of the orofacial system and upper airway structures, leading to improved patient comfort and better therapeutic outcome.\n\nThe primary objective of the study is to determine the effectiveness of OSA therapy in patients with skeletal Class I (eugnathic jaw relationship) using a DYNAMIC PROPULSION ORAL APPLIANCE (DPOA) with a mechanism that provides controlled, gentle, gradual and automatic mandible movement in propulsion during sleep.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 20 and 65 years\n* clinically confirmed diagnosis of mild or moderate obstructive sleep apnea (Apnea hypopnea index 15-30 episodes/hour)\n* sufficient number of periodontally healthy teeth to support the oral appliance\n* written informed consent of conformance with the study protocol\n\nExclusion Criteria:\n\n* age bellow 20 and over 65 years\n* patients not able or not willing to follow the study protocol\n* patients with severe OSA (Apnea hypopnea index \\> 30 episodes/hour) and/or some other breathing disturbances\n* patients with psychiatric, neurological or psychosomatic disorders\n* patients with Body Mass Index \\> 29kg/sqm\n* pregnancy\n* presence of the anatomical obstruction in the airways\n* severe periodontal disease (III and IV grade)\n* pathological changes in the structures of TMJ, muscles or ligaments\n* mandibular protrusion less than 3mm\n* orthodontic anomalies, malocclusions, II and III skeletal class, and orthodontic appliances'}, 'identificationModule': {'nctId': 'NCT07414420', 'briefTitle': 'Oral Dynamic Propulsion Appliance in Treatment of Patients With Obstructive Sleeping Apnea', 'organization': {'class': 'OTHER', 'fullName': 'University of Belgrade'}, 'officialTitle': 'Treatment Effects of Oral Dynamic Propulsion Appliance During the Sleeping Phase in Patients With Obstructive Sleeping Apnea', 'orgStudyIdInfo': {'id': '36/23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'test group', 'description': 'patients treated with dynamic oral appliance', 'interventionNames': ['Device: dynamic propulsion oral appliance treatment (DPOA)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control', 'description': 'patients treated with Elastic Mandibular Advancement (EMA) appliance', 'interventionNames': ['Device: elastic mandibular advancement appliance treatment']}], 'interventions': [{'name': 'dynamic propulsion oral appliance treatment (DPOA)', 'type': 'DEVICE', 'description': 'application of dynamic propulsion oral appliance for the treatment of obstructive sleep apnea during the sleeping phase', 'armGroupLabels': ['test group']}, {'name': 'elastic mandibular advancement appliance treatment', 'type': 'DEVICE', 'description': 'treatment of obstructive sleep apnea with elastic mandibular advancement appliance during the sleeping phase', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia', 'contacts': [{'name': 'Vojkan Lazic', 'role': 'CONTACT', 'email': 'stomfak@afrodita.rcub.bg.ac.rs', 'phone': '+381112685288'}, {'name': 'Aleksandra Čairović', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Luka Župac', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Marija S Milic, DDS PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Belgrade School of Dental Medicine', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}], 'centralContacts': [{'name': 'Vojkan Lazić, DDS PhD, full professor', 'role': 'CONTACT', 'email': 'stomfak@afrodita.rcub.bg.ac.rs', 'phone': '+381112685288'}], 'overallOfficials': [{'name': 'Aleksandra Čairović, DDS PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Belgrade School of Dental Medicine'}, {'name': 'Luka Župac, DDS, PhD student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Belgrade School of dental Medicine'}, {'name': 'Marija S Milic, DDS PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Belgrade School of Dental Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'The study database with anonymised patient data is planned to be shared on the Zenodo or Figshare website'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Belgrade', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DDS PhD, Assistant Professor', 'investigatorFullName': 'Marija S. Milic', 'investigatorAffiliation': 'University of Belgrade'}}}}