Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-26 @ 2:05 AM
Study NCT ID:
NCT07122505
Status:
RECRUITING
Last Update Posted:
2025-08-14
First Post:
2025-04-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Oromyofunctional Therapy: a Rehabilitation Program for OSA in Children With Down Syndrome and Prader-Willi Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D004314', 'term': 'Down Syndrome'}, {'id': 'D011218', 'term': 'Prader-Willi Syndrome'}], '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'}, {'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D000096803', 'term': 'Imprinting Disorders'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020247', 'term': 'Myofunctional Therapy'}], 'ancestors': [{'id': 'D012049', 'term': 'Rehabilitation of Speech and Language Disorders'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-11', 'studyFirstSubmitDate': '2025-04-28', 'studyFirstSubmitQcDate': '2025-08-11', 'lastUpdatePostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep: change in OAHI', 'timeFrame': 'measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy)', 'description': 'Obstructive apnea hypopnea index measured by polysomnography'}], 'secondaryOutcomes': [{'measure': 'Orofacial Myofunctional Outcomes: OMES score', 'timeFrame': 'measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy)', 'description': "core on the 'Orofacial Myofunctional Evaluation with scores' protocol."}, {'measure': 'Orofacial strength', 'timeFrame': 'measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy)', 'description': 'Lip and tongue strength measured with the Iowa Oral Performance Instrument.'}, {'measure': 'Quality of Life outcomes: CHQ-PF28', 'timeFrame': 'measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy)', 'description': 'Child Health Questionnaire (CHQ-PF28)'}, {'measure': 'Sleep: PSQ', 'timeFrame': 'measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy)', 'description': 'Score on the Pediatric Sleep Questionnaire'}, {'measure': 'Sleep: BSQ', 'timeFrame': 'measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy)', 'description': 'Score on the Berlin Sleep Questionnaire'}, {'measure': 'Sleep: PSG', 'timeFrame': 'measurement 1: pre therapy, measurement 2: post therapy (after 20 weeks of therapy)', 'description': 'Polysomnography: - Oxygen Desaturation Index - Saturation 93% - Minimum saturation - Mean saturation - Sleep efficiency - Apnea Index (AI) (- Apnea-Hyponea Index (AHI) = primary outcome derived from PSG)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Orofacial myofunctional therapy', 'Obstructive sleep apnea', 'Down syndrome', 'Prader-Willi syndrome'], 'conditions': ['Obstructive Sleep Apnea (OSA)', 'Orofacial Myofunctional Disorders']}, 'descriptionModule': {'briefSummary': 'Obstructive sleep apnea (OSA) is a prevalent medical condition with important implications for overall health and quality of life in both children. Therefore, it is important to treat OSA early and effectively. Children with Down syndrome and Prader-Willi syndrome have many predisposing factors for OSA, including mouth breathing, narrow upper airways resulting from craniofacial abnormalities, and generalized hypotonia, which increases UA collapsibility and multilevel obstructions. Adenotonsillectomy is the first-line treatment. Unfortunately, up to 55% of children with Down syndrome and up to 79% of children with Prader-Willi syndrome suffer from residual OSA after adenotonsillectomy. Therefore, exploring other treatment options for these children is an interesting and relevant avenue for research.\n\nThis study will evaluate the effectiveness of orofacial myofunctional therapy as a treatment option for children with Down syndrome or Prader-Willi syndrome and obstructive sleep apnea. Orofacial myofunctional therapy consists of a set of oropharyngeal exercises to correct abnormal orofacial functions and strengthen upper airway muscles that are involved in maintaining airway patency. Both objective and subjective/patient-reported outcomes are collected to obtain a comprehensive understanding of the potential of orofacial myofunctional therapy as a treatment for OSA.', 'detailedDescription': 'Objective: Determine the effect of 20 weeks of orofacial myofunctional therapy on oromyofunctional, sleep and sleep-related quality of life outcomes in children with OSA (AHI \\> 1) and Down syndrome or Prader-Willi syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged between 4-18\n* Diagnosed with Down syndrome or Prader-Willi syndrome\n* Diagnosed with Obstructive Sleep Apnea on Polysomnography (AHI\\<1)\n\nExclusion criteria:\n\n* History of Orofacial Myofunctional Therapy\n* Undergoing an orthodontic procedure during the study period\n* Undegoing an OSA treatment during the study period\n* Orofacial congenital deformities (not related to Down syndrome or Prader-Willi syndrome)'}, 'identificationModule': {'nctId': 'NCT07122505', 'acronym': 'OROFIT-P', 'briefTitle': 'Oromyofunctional Therapy: a Rehabilitation Program for OSA in Children With Down Syndrome and Prader-Willi Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Ghent'}, 'officialTitle': 'Oromyofunctional Training: an Innovative Rehabilitation Program for Pediatric Obstructive Sleep Apnea', 'orgStudyIdInfo': {'id': 'ONZ-2024-0002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OSA-patients', 'description': 'orofacial myofunctional therapy', 'interventionNames': ['Behavioral: Orofacial myofunctional therapy']}], 'interventions': [{'name': 'Orofacial myofunctional therapy', 'type': 'BEHAVIORAL', 'otherNames': ['Oromyofunctional therapy', 'Oropharyngeal exercises'], 'description': 'Orofacial myofunctional therapy consists of a set of oropharyngeal exercises to correct abnormal orofacial functions such as mouth breathing and a caudal tongue position, and strengthen upper airway muscles (e.g., muscles of the tongue and soft palate) that are involved in maintaining airway patency.', 'armGroupLabels': ['OSA-patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Jolien Verbeke', 'role': 'CONTACT', 'email': 'joliverb.verbeke@ugent.be', 'phone': '+32 9 332 01 43'}, {'name': 'Kristiane Van Lierde, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ghent University', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}], 'centralContacts': [{'name': 'Jolien Verbeke, MSc', 'role': 'CONTACT', 'email': 'joliverb.verbeke@ugent.be', 'phone': '+32495195718'}], 'overallOfficials': [{'name': 'Kristiane Van Lierde, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Ghent'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Ghent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}