Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-03-07 @ 11:47 PM
Study NCT ID:
NCT02761902
Status:
UNKNOWN
Last Update Posted:
2016-05-04
First Post:
2016-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Normal Polysomnography Values in Healthy Children and Adolescents in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}, 'targetDuration': '3 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-05-02', 'studyFirstSubmitDate': '2016-05-02', 'studyFirstSubmitQcDate': '2016-05-02', 'lastUpdatePostDateStruct': {'date': '2016-05-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'obstructive apneas per hour of sleep', 'timeFrame': '7 hours of sleep'}], 'secondaryOutcomes': [{'measure': 'minimum oxygen desaturation of sleep', 'timeFrame': '7 hours of sleep'}, {'measure': 'central apneas per hour of sleep', 'timeFrame': '7 hours of sleep'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Children', 'Polysomnography', 'sleep', 'obstructive sleep apnea;', 'Chinese'], 'conditions': ['Sleep Apnea']}, 'referencesModule': {'references': [{'pmid': '7300438', 'type': 'BACKGROUND', 'citation': 'Guilleminault C, Korobkin R, Winkle R. A review of 50 children with obstructive sleep apnea syndrome. Lung. 1981;159(5):275-87. doi: 10.1007/BF02713925. No abstract available.'}, {'pmid': '6478890', 'type': 'BACKGROUND', 'citation': 'Berry DT, Webb WB, Block AJ. Sleep apnea syndrome. A critical review of the apnea index as a diagnostic criterion. Chest. 1984 Oct;86(4):529-31. doi: 10.1378/chest.86.4.529.'}, {'pmid': '1443876', 'type': 'BACKGROUND', 'citation': "Rosen CL, D'Andrea L, Haddad GG. Adult criteria for obstructive sleep apnea do not identify children with serious obstruction. Am Rev Respir Dis. 1992 Nov;146(5 Pt 1):1231-4. doi: 10.1164/ajrccm/146.5_Pt_1.1231."}, {'pmid': '12527608', 'type': 'BACKGROUND', 'citation': 'Urschitz MS, Wolff J, Von Einem V, Urschitz-Duprat PM, Schlaud M, Poets CF. Reference values for nocturnal home pulse oximetry during sleep in primary school children. Chest. 2003 Jan;123(1):96-101. doi: 10.1378/chest.123.1.96.'}, {'pmid': '14592355', 'type': 'BACKGROUND', 'citation': "Quan SF, Goodwin JL, Babar SI, Kaemingk KL, Enright PL, Rosen GM, Fregosi RF, Morgan WJ. Sleep architecture in normal Caucasian and Hispanic children aged 6-11 years recorded during unattended home polysomnography: experience from the Tucson Children's Assessment of Sleep Apnea Study (TuCASA). Sleep Med. 2003 Jan;4(1):13-9. doi: 10.1016/s1389-9457(02)00235-6."}, {'pmid': '15858805', 'type': 'BACKGROUND', 'citation': 'Traeger N, Schultz B, Pollock AN, Mason T, Marcus CL, Arens R. Polysomnographic values in children 2-9 years old: additional data and review of the literature. Pediatr Pulmonol. 2005 Jul;40(1):22-30. doi: 10.1002/ppul.20236.'}, {'pmid': '15006944', 'type': 'RESULT', 'citation': 'Uliel S, Tauman R, Greenfeld M, Sivan Y. Normal polysomnographic respiratory values in children and adolescents. Chest. 2004 Mar;125(3):872-8. doi: 10.1378/chest.125.3.872.'}]}, 'descriptionModule': {'briefSummary': "The study is designed to investigate normal polysomnographic respiratory values of Chinese healthy children and adolescents. By collecting the polysomnography (PSG) data and parameters of respiratory and sleep architecture，we hope to characterize normal polysomnography values in Chinese children and adolescents and to establish respiratory reference values for pediatric polysomnography which based on Chinese children's data.", 'detailedDescription': "We plan to recruit 200 healthy, normal children and adolescents in this study, age ranging from 3 to 15 years. All of them will be invited to undergo an overnight polysomnography for at least 7h in Beijing Children's Sleep Center, meanwhile the parameters about sleep including EEG, electromyography, electrooculography, ECG, pulse oximetry arterial oxygen saturation (SpO2), chest wall and abdomen motion, oral and nasal airflow, and end-tidal PCO2 (PETCO2) will be recorded.\n\nBased on the data we hope to give recommendation of normal PSG parameters of Chinese kids, and on this basis,to develop the diagnosis creteria for obstructive sleep apnea syndrome which will be more suitable for Chinese children conditions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '3 to 14-year-old healthy children from the community of China', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1.3 to 14-year-old children 2.from the community of China 3.healty children\n\nExclusion Criteria:\n\n1. children with nocturnal snoring, continuous mouth breathing, difficulty breathing and apnea when sleep.\n2. children with craniofacial abnormalities, such as Down's syndrome, Crouzon syndrome, achondroplasia, mandibular hypoplasia and facial mandibularetc hypoplasia.\n3. children with history of upper respiratory tract infection nearly two weeks.\n4. children with adenoids, tonsils, throat, glottis, trachea, lungs and history of thoracic surgery.\n5. children with nose-sinusitis, allergic rhinitis, asthma, acut or purulent tonsillitis acute phase.\n6. children with any medical or surgicaldiseases.\n7. children who have to use use sedation to maintain sleep.\n8. parents or child not understand the study or do not agree to take part in."}, 'identificationModule': {'nctId': 'NCT02761902', 'acronym': 'PSGNV', 'briefTitle': 'Normal Polysomnography Values in Healthy Children and Adolescents in China', 'organization': {'class': 'OTHER', 'fullName': "Beijing Children's Hospital"}, 'officialTitle': 'Research to Characterize Normal Polysomnography Values in Healthy Children and Adolescents in China', 'orgStudyIdInfo': {'id': 'BCH-OSAHS-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Preschool group', 'description': '3-6 years old'}, {'label': 'school age group', 'description': '7-12 years old'}, {'label': 'Adolescence group', 'description': '13-15 years old'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100045', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaodan Li, MD', 'role': 'CONTACT', 'email': 'dannylxd1989@163.com', 'phone': '86-15210900832'}, {'name': 'Zhifei Xu, MD PHD', 'role': 'CONTACT', 'email': 'zhifeixu@aliyun.com', 'phone': '86-010-59616395'}], 'facility': "Children's Sleep Center，Beijing,China", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Xiaodan Li, MD', 'role': 'CONTACT', 'email': 'dannylxd1989@163.com', 'phone': '86-15210900832'}, {'name': 'Zhifei Xu, MD,PHD', 'role': 'CONTACT', 'email': 'zhifeixu@aliyun.com', 'phone': '86-010-59616395'}], 'overallOfficials': [{'name': 'Xin Ni, MD PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': "Beijing Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Beijing Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Hospital director', 'investigatorFullName': 'Xin Ni', 'investigatorAffiliation': "Beijing Children's Hospital"}}}}