Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT06352658
Status:
COMPLETED
Last Update Posted:
2025-01-30
First Post:
2024-04-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Different Treatments for Obstructive Sleep Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001049', 'term': 'Apnea'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-27', 'studyFirstSubmitDate': '2024-04-02', 'studyFirstSubmitQcDate': '2024-04-02', 'lastUpdatePostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Apnea hypopnea index', 'timeFrame': '4 months', 'description': 'The AHI measures an average number of apnea and hypopnea episodes that you experience per hour. According to the American Academy of Sleep Medicine (AASM) it is categorized into mild (5-15 events/hour), moderate (15-30 events/hr), and severe (\\> 30 events/hr)'}, {'measure': 'Epwoth sleeplness scale (ESS)', 'timeFrame': '4 months', 'description': "The ESS is a subjective measure of a patient's sleepiness. The test is a list of eight situations in which the patien rates their tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing. All scores on the ESS fall between 0 and 24. Scores from 0 to 10 reflect normal levels of daytime sleepiness, and scores over 10 are considered to reflect excessive daytime sleepiness."}, {'measure': 'Oxygen saturation', 'timeFrame': '4 months', 'description': 'This will be measured using an oximeter. A normal level of oxygen is usually 95% or higher.'}, {'measure': 'Snoring index', 'timeFrame': '4 months', 'description': "Snoring index measures the total number of snores per hour of sleep. This is calculated by dividing your total sleeping time by your snoring frequency. The normal range depends on the person's gender and the stage of sleep"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Apnea']}, 'descriptionModule': {'briefSummary': 'This was a prospective randomized controlled clinical trial that aimed to evaluate the efficacy of three treatments for obstructive sleep Apnea OSA:\n\n1. Conventionally constructed mandibular advancement device (MAD).\n2. Digitally constructed mandibular advancement device (CAD CAM).\n3. Uvulopalatopharyngeoplasty (UPPP).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adequate nasal air flow capacity as determined by qualified otolaryngologist\n* Cases showing improvement in airway with mandibular advancement on Acoustic Pharyngometry (AP)\n* Patients with the minimum component of dentition to support MDSA.\n* Patients with the mandibular protrusive movement of more than 5 mm\n* Body mass index (BMI) less than 30 kg/m2\n\nExclusion Criteria:\n\n* Severe nasal passage obstructions or allergies\n* Obesity (BMI greater than 30 kg/m2 )\n* Cases with Mallampati score greater than Class 1\n* Systemic complications, syndrome, or disease affecting airway\n* Severe periodontal disease'}, 'identificationModule': {'nctId': 'NCT06352658', 'briefTitle': 'Efficacy of Different Treatments for Obstructive Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': 'University of Alexandria'}, 'officialTitle': 'Efficacy of Different Treatment Modalities for Obstructive Sleep Apnea: a Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '#1/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional mandibular advancement device', 'interventionNames': ['Device: Conventional mandibular advancement device']}, {'type': 'EXPERIMENTAL', 'label': 'CAD CAM mandibular advancement device', 'interventionNames': ['Device: CAD CAM mandibular advancement device']}, {'type': 'EXPERIMENTAL', 'label': 'Uvuloplatopharyngeoplasty UPPP', 'interventionNames': ['Procedure: Uvuloplatopharyngeoplasty UPPP']}], 'interventions': [{'name': 'Conventional mandibular advancement device', 'type': 'DEVICE', 'description': 'With a vacuum mahine (Biostar, NY) a 2-mm-thick hard, clear resin sheet was adapted to the cast. The excess material was cut, borders were trimmed and smoothed. Maxillary mandibular casts were mounted by a protrusive the interocclusal record. The appliances were re-placed on the mounted casts to be splinted to form a Monoblock MAD by autopolymerizing acrylic resin at the premolar -molar area.', 'armGroupLabels': ['Conventional mandibular advancement device']}, {'name': 'CAD CAM mandibular advancement device', 'type': 'DEVICE', 'description': '3D models for the stone casts were constructed with laser scanning machine (accuracy \\<20 µm; D500, 3shape).\n\nMaxillary and mandibular casts were rescanned in the achieved 75% advancement position and monoblock device was designed by CAD (computer-aided design) with 3D software (3-matic; Materialise) and printed by', 'armGroupLabels': ['CAD CAM mandibular advancement device']}, {'name': 'Uvuloplatopharyngeoplasty UPPP', 'type': 'PROCEDURE', 'description': 'uvulopalatopharyngeoplasty UPPP were performed by the same ENT surgeon under GA.', 'armGroupLabels': ['Uvuloplatopharyngeoplasty UPPP']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Faculty of Dentistry, Alexandria University, Egypt', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'Mona Sabry, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Dentistry, Alexandria University, Egypt'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nourhan M.Aly', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer of Dental Public Health', 'investigatorFullName': 'Nourhan M.Aly', 'investigatorAffiliation': 'University of Alexandria'}}}}