Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-26 @ 4:10 AM
Study NCT ID:
NCT05830227
Status:
RECRUITING
Last Update Posted:
2023-04-26
First Post:
2023-04-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Infrared Thermal Imaging in Diagnosis of OSAHS in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-14', 'studyFirstSubmitDate': '2023-04-14', 'studyFirstSubmitQcDate': '2023-04-14', 'lastUpdatePostDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between infrared expression of oral, nasal and pharyngeal inflammation and disease severity', 'timeFrame': '2025', 'description': 'Correlation between infrared expression of oral, nasal and pharyngeal inflammation and disease severity (sleep breathing parameters OAHI and LSpO2)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infrared-thermal-imaging']}, 'descriptionModule': {'briefSummary': "OSAHS is a common sleep breathing disorder in children, with the same incidence as childhood asthma, and is mainly caused by upper airway stenosis caused by tonsil/adenoid hyperplasia. Clinical findings show that children with OSAHS often present rhinitis symptoms and like rubbing eyes, but there is no evidence to suggest a correlation. Children with OSAHS suffer from recurrent hypoxemia during sleep, and the existing detection methods such as lateral nasopharyngeal radiographs and electronic nasopharyngoscopy can only reflect the structural and morphological changes of the oral, nasal and pharyngeal tissues, but cannot prove their functional status. Previous studies have found that infrared thermal imaging can reflect the oral, nasal and pharyngeal inflammation of patients, and the infrared expression of patients' frontal region and eyes can also reflect the physiological changes caused by sleep deprivation.", 'detailedDescription': 'In this project, the children were divided into four groups: primary snoring, critical OSAHS, mild OSAHS and moderate to severe OSAHS, and the tests were completed, including lateral nasopharyngeal radiographs, infrared detection of oropharynx and pharynx, infrared detection of frontal area and eye area, intelligence and behavior scale assessment, etc. Furthermore, the correlation between infrared detection and obstructive sleep apnea hypopnea index, peripheral blood oxygen saturation, adenoid hyperplasia degree of nasopharyngeal lateral film as parameters were analyzed, and the sensitivity and specificity of infrared detection was determined to confirm the diagnostic value of OSAHS. It provides a theoretical basis for finding a convenient, non-damaging, non-radiation, visual and suitable for children functional image detection method.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '2 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '-Children ages 2 to 14 with SDB related symptoms', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children ages 2 to 14 with SDB related symptoms\n\nExclusion Criteria:\n\n* 1\\) Congenital abnormalities of the nose and throat or airway;\n\n 2\\) craniofacial deformity\n\n 3\\) Neuromuscular dysregulation\n\n 4\\) History of adenoids and/or tonsillectomy.'}, 'identificationModule': {'nctId': 'NCT05830227', 'briefTitle': 'Evaluation of Infrared Thermal Imaging in Diagnosis of OSAHS in Children', 'organization': {'class': 'OTHER', 'fullName': 'State Key Laboratory of Respiratory Disease'}, 'officialTitle': 'Evaluation of Infrared Thermal Imaging in Diagnosis of Obstructive Sleep Apnea Hypopnea Syndrome in Children', 'orgStudyIdInfo': {'id': 'GuangzhouIRD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Primary snoring group', 'description': 'Primary snoring group'}, {'label': 'Critical OSAHS group', 'description': 'Critical OSAHS group'}, {'label': 'Mild OSAHS group', 'description': 'Mild OSAHS group'}, {'label': 'Moderate to severe OSAHS group', 'description': 'Moderate to severe OSAHS group'}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangdong', 'state': 'Uangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lijun Z [lzeng]', 'role': 'CONTACT', 'email': '865391757@qq.com', 'phone': '13450360939', 'phoneExt': 'Lijun Zeng'}], 'facility': 'Lijun Zeng [lzeng]', 'geoPoint': {'lat': 42.76832, 'lon': 129.33635}}], 'centralContacts': [{'name': 'Lijun Z [lzeng], visiting staff', 'role': 'CONTACT', 'email': '865391757@qq.com', 'phone': '13450360939', 'phoneExt': 'Lijun Zeng'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Observe and study before sharing'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State Key Laboratory of Respiratory Disease', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Guangzhou Institute of Respiratory Disease', 'investigatorFullName': 'Lijun Zeng', 'investigatorAffiliation': 'Guangzhou Institute of Respiratory Disease'}}}}