Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2026-02-17 @ 10:27 PM
Study NCT ID:
NCT05459935
Status:
RECRUITING
Last Update Posted:
2025-08-21
First Post:
2022-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Photobiomodulation for Pediatric Hypertrophic Tonsils
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Sham intervention (nonactivated/unpowered phototherapy intervention)'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2030-01-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-19', 'studyFirstSubmitDate': '2022-05-19', 'studyFirstSubmitQcDate': '2022-07-12', 'lastUpdatePostDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tonsil Size', 'timeFrame': 'immediately after intervention', 'description': 'Tonsil size grading (Brodsky score): 0-4, 0 being not present 4 being restrictive to entire airway. Lower scores are better. Each integer represents 25% obstruction of airway (0 being not visible, 1 being 0-25%, 2 being 25-50%, 3 being 50-75%, 4 being 75-100%). There is no abbreviated scale title.'}], 'secondaryOutcomes': [{'measure': 'AHI Score', 'timeFrame': 'Next Day (next night)', 'description': 'Comparisons of before and after AHI score by portable sleep testing device'}, {'measure': 'Questionnaire Improvement', 'timeFrame': 'night after, per quarter after for 1 year', 'description': 'Comparisons of before and after PSQ (pediatric sleep questionnaire) scores'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Pediatric Sleep Apnea', 'Obstructive Sleep Apnea', 'Tonsils Hypertrophy']}, 'descriptionModule': {'briefSummary': "Pediatric obstructive sleep apnea is a medical condition where a child has great difficulty with breathing, or stops breathing all together, while asleep. This is a medical condition for which the primary treatment is usually a surgery targeted towards removing swollen tonsils and adenoids. However, surgical removal of tonsils and adenoids comes with its own risks of complications during and after surgery including secondary hemorrhage and long term increased risks for respiratory and infectious diseases. Perhaps more importantly, surgical removal of swollen tonsils and adenoids does not guarantee successful treatment of a child's obstructive sleep apnea.\n\nThe use of laser light therapy in a non-cutting manner (known as photobiomodulation and abbreviated as PBM) has been a relatively new development within medicine. Recently, dentists have begun to use PBM as a method to treat adult snoring and, with lesser success, adult obstructive sleep apnea. To date, there are no known side effects to the use of PBM for the treatment of any sleep breathing disorders. However, no research has been published on the use of PBM for the treatment of pediatric obstructive sleep apnea or swollen tonsils in children\n\nThe purpose of this project is to determine whether photobiomodulation can provide a beneficial effect on pediatric hypertrophic tonsils and pediatric obstructive sleep apnea and, if it does, to create the appropriate workflow, referral pathways, and treatment parameters for clinicians to provide this treatment as a multidisciplinary approach in a clinical setting.\n\nThe investigators hypothesize that photobiomodulation can be used successfully to decrease the pediatric hypertrophic tonsils in children with symptoms of an pediatric obstructive sleep apnea and will also result in improved AHI scores (be able to breath significantly better when sleeping) in these children."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Brodsky visually graded tonsils 3/4\n* patient must assent, parent must consent, to all pre and post follow up including sleep testing\n* patient and parent must agree to normal referral protocols regardless of participation within this study or not\n\nExclusion Criteria:\n\n* visual indication of cancerous growth\n* currently under treatment (pharmacologic, other) for hypertrophic tonsils\n* already scheduled for surgical intervention of hypertrophic tonsils'}, 'identificationModule': {'nctId': 'NCT05459935', 'briefTitle': 'Photobiomodulation for Pediatric Hypertrophic Tonsils', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': 'Treatment of Pediatric Hypertrophic Tonsils and Pediatric Obstructive Sleep Apnea by Non-invasive Photobiomodulation', 'orgStudyIdInfo': {'id': '00103330'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PBM Tonsil Arm', 'description': 'Photobiomodulation exposure of hypertrophic tonsils', 'interventionNames': ['Device: PBM Tonsil Arm']}, {'type': 'SHAM_COMPARATOR', 'label': 'Tonsil Control Arm', 'description': 'Sham (non-powered) exposure of hypertrophic tonsils', 'interventionNames': ['Device: Sham PBM Tonsil Arm']}], 'interventions': [{'name': 'PBM Tonsil Arm', 'type': 'DEVICE', 'otherNames': ['Fotona Lightwalker AT S'], 'description': 'exposure of hypertrophic tonsils to photobiomodulation', 'armGroupLabels': ['PBM Tonsil Arm']}, {'name': 'Sham PBM Tonsil Arm', 'type': 'DEVICE', 'otherNames': ['Fotona Lightwalker AT S - non-powered'], 'description': 'non-powered exposure of hypertrophic tonsils to photobiomodulation', 'armGroupLabels': ['Tonsil Control Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T5X 3N5', 'city': 'Edmonton', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Enoch Ng, DDS', 'role': 'CONTACT', 'email': 'enoch@ualberta.ca'}, {'name': 'Manuel Lagravere Vich, DDS', 'role': 'CONTACT', 'email': 'mlagravere@ualberta.ca'}], 'facility': 'Enjoy Dental', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'centralContacts': [{'name': 'Manuel Lagravere, DDS, PhD', 'role': 'CONTACT', 'email': 'manuel@ualberta.ca', 'phone': '(780) 492-7696'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alberta', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}