Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2026-01-02 @ 7:46 AM
Study NCT ID:
NCT05651750
Status:
UNKNOWN
Last Update Posted:
2022-12-15
First Post:
2022-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Medical vs Surgical Treatment in OSA Among Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C093875', 'term': 'montelukast'}, {'id': 'C523187', 'term': 'fluticasone furoate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-07', 'studyFirstSubmitDate': '2022-12-07', 'studyFirstSubmitQcDate': '2022-12-07', 'lastUpdatePostDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate PSQ as clinical tool in the decision between medical vs surgical treatment for adeno-tonsillar hypertrophy', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'To determine clinical response to montelukast or nasal steroids based on PSQ results', 'timeFrame': '1 year'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['To Evaluate PSQ as Clinical Tool in the Decision Between Medical and Surgical Treatment for Adenotonsillar Hypertrophy', 'To Determine Clinical Response to Montelukast or Nasal Steroids Based on PSQ Results']}, 'descriptionModule': {'briefSummary': 'Adeno-tonsillar hypertrophy causing OSA are treated surgically however, over the last years it has been shown that montelukast or nasal steroidal spray can significantly improve symptoms, adenoid size, and polysomnographic results in pediatric non-severe OSA, excluding the need for surgery. A literature review from 2016 suggested that by using anti-leukotrienes as anti-inflammatory appears to be beneficial in children with a non-severe OSA and can be offered to parents as a treatment option before, or instead of surgery. In addition, nasal steroidal spray may be considered useful in decreasing adenoid pad size and the severity of symptoms related to adenoidal hypertrophy \\[9\\]. Despite emerging evidence that both montelukast and nasal steroids are effective in the treatment of pediatric SDB, further evidence is still required. . adeno-tonsillar hypertrophy causing OSA are treated surgically however, over the last years it has been shown that montelukast or nasal steroidal spray can significantly improve symptoms, adenoid size, and polysomnographic results in pediatric non-severe OSA, excluding the need for surgery. A literature review from 2016 suggested that by using anti-leukotrienes as anti-inflammatory appears to be beneficial in children with a non-severe OSA and can be offered to parents as a treatment option before, or instead of surgery. In addition, nasal steroidal spray may be considered useful in decreasing adenoid pad size and the severity of symptoms related to adenoidal hypertrophy. Despite emerging evidence that both montelukast and nasal steroids are effective in the treatment of pediatric SDB, further evidence is still required.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '2 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children between 2-16 years of age referred to the pediatric otolaryngology outpatient clinic due to OSA and have not undergone previous adeno-tonsillar procedure\n\nExclusion Criteria:\n\n* children with severe OSA who need an urgent surgery and cannot be postponed, children with nasal polyposis, craniofacial malformations (e.g. cleft lip and palate), and genetic diseases (e.g. Down syndrome).'}, 'identificationModule': {'nctId': 'NCT05651750', 'briefTitle': 'Medical vs Surgical Treatment in OSA Among Children', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Assaf-Harofeh Medical Center'}, 'officialTitle': 'Medical vs Surgical Treatment Decision in Pediatric Obstructive Sleep Apnea Using Sleep Questionnaire', 'orgStudyIdInfo': {'id': 'Assaf-HarofehMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Montelukast tab', 'interventionNames': ['Drug: Montelukast']}, {'type': 'EXPERIMENTAL', 'label': 'Fluticasone nasal spray', 'interventionNames': ['Drug: Fluticasone Furoate']}], 'interventions': [{'name': 'Montelukast', 'type': 'DRUG', 'otherNames': ['Singulair'], 'description': 'receiving 2 months treatment with Montelukast once a day', 'armGroupLabels': ['Montelukast tab']}, {'name': 'Fluticasone Furoate', 'type': 'DRUG', 'otherNames': ['Avamys'], 'description': 'receiving 2 months treatment with Fluticasone Furoate nasal spray once a day', 'armGroupLabels': ['Fluticasone nasal spray']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Be’er Ya‘aqov', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Sarah Rothman, MD', 'role': 'CONTACT'}], 'facility': 'Assaf-Harofeh Medical Center', 'geoPoint': {'lat': 31.93864, 'lon': 34.83749}}], 'centralContacts': [{'name': 'Sarah Rothman, MD', 'role': 'CONTACT', 'email': 'sarirothman@hotmail.com', 'phone': '+972-545743365'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assaf-Harofeh Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}