Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 1:15 PM
Study NCT ID:
NCT07446634
Status:
RECRUITING
Last Update Posted:
2026-03-03
First Post:
2026-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Maxillomandibular Advancement Surgery for Treatment of Obstructive Sleep Apnoea Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], 'ancestors': [{'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective singel center study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2032-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-25', 'studyFirstSubmitDate': '2026-02-11', 'studyFirstSubmitQcDate': '2026-02-25', 'lastUpdatePostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Apnea Hypopnea Index (AHI/h)', 'timeFrame': 'Registration presurgically and at 3 months, 2 years and 5 years post operatively', 'description': 'Change in AHI/h. Lower value means better outcome, value \\< 5 is considered healthy.'}], 'secondaryOutcomes': [{'measure': 'Upper airway volume', 'timeFrame': 'Registration presurgically and at 3 months, 2 years and 5 years post operatively', 'description': 'Changes in upper airway volume measured in mm\\^3.'}, {'measure': 'Airway velocity', 'timeFrame': 'Registration presurgically and at 3 months, 2 years and at 5 years post operatively.', 'description': 'Changes in airway velocity measured in m/s'}, {'measure': 'Epworth Sleepiness Scale (ESS)', 'timeFrame': 'Registration presurgically and at 3 months, 2 years and 5 years post operatively', 'description': 'Assessment of daytime sleepiness using Epworth Sleepiness Scale before and after treatment. Minimum score 0, maximum 24. Higher scores mean a worse outcome,'}, {'measure': 'Blood pressure', 'timeFrame': 'Registration presurgically and at 3 months, 2 years and 5 years post operatively', 'description': 'Assessment of the effect of surgery on both systolic and diastolic blood pressure and blood pressure medication, mmHg.'}, {'measure': 'Quality of Life (QoL), Short Form-36 Health Survey', 'timeFrame': 'Registration presurgically and at 3 months, 2 years and 5 years post operatively', 'description': 'Evaluation of participants Quality of Life through validated questionnaire 36-Item Short Form Health Survey (SF-36). SF-36 is a self-reported questionnaire designed to measure generic health-related quality of life across eight domains, such as physical functioning, bodily pain, and mental health. Higher score means worse outcome.'}, {'measure': 'Quality of Life (QoL), Oral Health Impact Profile - Swedish version', 'timeFrame': 'Registration presurgically and at 3 months, 2 years and 5 years post operatively', 'description': 'Evaluation of participants Quality of Life through validated questionnaire Oral Health Impact Profile-49 - Swedish version (OHIP-S). It is a comprehensive instrument designed to measure oral health-related quality of life (OHRQoL) across seven dimensions: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. Higher score means worse outcome.'}, {'measure': 'Quality of Life (QoL), Jaw Function Limitation Scale.', 'timeFrame': 'Registration presurgically and at 3 months, 2 years and 5 years post operatively', 'description': 'Evaluation of participants Quality of Life through validated questionnaire Jaw Functional Limitation Scale (JFLS). JFLS is a patient-reported instrument used to assess functional status and limitations of the masticatory system (the jaw), typically in individuals with temporomandibular disorders. Higher score means worse outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sleep Apnea', 'Orthognathic Surgical Procedure', 'Tomography', 'Computational Fluid Dynamics'], 'conditions': ['Sleep Apnea, Obstructive']}, 'descriptionModule': {'briefSummary': 'This study looks at how jaw surgery called maxillomandibular advancement with counterclockwise rotation affects breathing during sleep in people with moderate to severe obstructive sleep apnea who cannot tolerate standard treatments such as Continous Positive Airway pressure treatment. The participants are followed over time to see whether the surgery improves sleep apnea symptoms, daytime sleepiness, and airway size, and whether these improvements last. Advanced three-dimensional imaging and airflow analysis are used to better understand how the surgery changes the airway and breathing. The goal is to evaluate the long-term effectiveness and safety of this surgical treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of obstructive sleep apnea with AHI ≥15 events/h.\n* Residence and/or registration in Dalarna County\n* Body mass index (BMI; kg/m\\^2) between 15 and 35\n* Documented failure of CPAP or mandibular advancement therapy.\n\nExclusion Criteria:\n\n* Medical conditions contraindicating general anesthesia.\n* American Society of Anesthesiologists Physical Status (ASA) Class III-VI\n* Central sleep apnea\n* Narcolepsy\n* Prior orthognathic surgery\n* History of tumor disease or radiotherapy of the jaws. Participants with systemic conditions associated with an increased risk of OSA. Such risks include;\n* Hypothyroidism\n* Acromegaly\n* Diabetes mellitus\n* Active generalized rheumatoid arthritis\n* Clinically manifest periodic limb movement disorder\n* Restless legs syndrome.'}, 'identificationModule': {'nctId': 'NCT07446634', 'acronym': 'OSAS', 'briefTitle': 'Maxillomandibular Advancement Surgery for Treatment of Obstructive Sleep Apnoea Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Dalarna County Council, Sweden'}, 'officialTitle': 'Maxillomandibular Advancement Surgery for Treatment of Obstructive Sleep Apnoea Syndrome', 'orgStudyIdInfo': {'id': '2013/125'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Single arm study with counterclockwise rotational maxillo-mandibular advancement surgery', 'interventionNames': ['Procedure: Maxillomandibular advancement surgery with counterclockwise rotation']}], 'interventions': [{'name': 'Maxillomandibular advancement surgery with counterclockwise rotation', 'type': 'PROCEDURE', 'description': 'Maxillary advancement by LeFort I osteotomy and mandibular advancement by bilateral sagittal split osteotomy', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79182', 'city': 'Falun', 'state': 'Dalarna County', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Jani MA Talvilahti, DDS, Head', 'role': 'CONTACT', 'email': 'jani.talvilahti@regiondalarna.se', 'phone': '+46 49 21 08'}], 'facility': 'Falu Hospital', 'geoPoint': {'lat': 60.60357, 'lon': 15.62597}}], 'centralContacts': [{'name': 'Jani M A Talvilahti, DDS, Head', 'role': 'CONTACT', 'email': 'jani.talvilahti@regiondalarna.se', 'phone': '+46 23 49 21 08'}], 'overallOfficials': [{'name': 'Andreas Thor, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Surgical Sciences, Oral and Maxillofacial Surgery, Uppsala University, Uppsala, Sweden.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jani Talvilahti', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of Maxillofacial Surgery, DDS', 'investigatorFullName': 'Jani Talvilahti', 'investigatorAffiliation': 'Dalarna County Council, Sweden'}}}}