Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2025-12-27 @ 2:54 AM
Study NCT ID:
NCT05031793
Status:
COMPLETED
Last Update Posted:
2021-09-02
First Post:
2018-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Establishing the Collaborative Care Model for Pediatric Allergic Rhinitis With Sleep Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-30', 'studyFirstSubmitDate': '2018-05-16', 'studyFirstSubmitQcDate': '2021-08-30', 'lastUpdatePostDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change of SN-5 scores', 'timeFrame': 'week 8', 'description': 'SN-5 questionnaire is a tool to evaluate quality of life of sinus and nasal symptoms'}], 'secondaryOutcomes': [{'measure': 'The change of scores of Pediatric allergic disease quality of life questionnaire (PADQLQ)', 'timeFrame': 'week 8', 'description': 'Pediatric allergic disease quality of life questionnaire (PADQLQ) is a validated tool to evaluate quality of life of pediatric allergic disease.'}, {'measure': 'The change of scores of questionnaire of pediatric obstructive sleep apnea (OSA-18)', 'timeFrame': 'week 8', 'description': 'Obstructive Sleep Apnea-18'}, {'measure': 'The change of scores of Pediatric Sleep Questionnaire', 'timeFrame': 'week 8', 'description': 'Pediatric Sleep Questionnaire is a validated questionnaire to evaluate sleep quality among children'}, {'measure': 'The change of hyperactivity-inattentive condition', 'timeFrame': 'week 8', 'description': 'SNAP-IV is a validated tool designed by Swanson, Nolan and Pelham ,is the questionnaire used to evaluate hyperactivity-inattentive condition .'}, {'measure': 'dosage of intra-nasal corticosteroid', 'timeFrame': 'week 8', 'description': 'Weight change of intra-nasal corticosteroid before and after study'}, {'measure': 'Apnea-Hyponea index', 'timeFrame': 'week 12', 'description': 'Apnea-Hyponea index is evaluated by polysomnography'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Allergic rhinitis', 'Sleep disorder', 'Obstructive sleep apnea', 'Integrative care clinic', 'TCM', 'Western medicine'], 'conditions': ['Allergic Rhinitis', 'Sleep Disorder']}, 'descriptionModule': {'briefSummary': 'The purpose of study is to compared the impact of the integrative care clinic to ordinary western medicine among patients of moderate persistent allergic rhinitis combined with sleep disorder and establishing the collaborative care model of TCM and western medicine for pediatric allergic rhinitis with sleep disorder.\n\nInvestigators invited children aged below 18 years old to the integrative care clinic as experimental group, who have persistent moderate allergic rhinitis, more than 60 scores of the OSA-18 sleep questionnaire, and can accept integrative therapy. The controlled group is patients who receive ordinary western treatment. Investigators compare these two groups by questionnaires of OSA-18,SN-5, PADQLQ,SNAP-IV, the dose of nasal corticosteroid , and polysomnography.', 'detailedDescription': 'In Taiwan, there are many patients suffer from pediatric allergic rhinitis and lead to the medical heavy budget. The persistent symptoms would cause sleep disorder or complicated with pediatric obstructive sleep apnea. It would affect the growth development ,attention deficiency, or psychiatric cognition problems. Obstructive sleep apnea for a long time would result in cardiovascular, endocrine, and metabolic complications if not well-treated.\n\nPatients of allergic rhinitis combined with sleep disorder are classified to moderate persistent type by ARIA, who are intractable to ordinary treatment. Investigators invited them to the integrative care clinic. In addition to the ordinary western medicine, the therapies in the integrative care clinic included herbal medicine, nasal aerosol inhalation, acupuncture, and health care education. The purpose of our study is to compared the impact of the integrative care clinic to ordinary western medicine among patients of moderate persistent allergic rhinitis combined with sleep disorder and establishing the collaborative care model of TCM and western medicine for pediatric allergic rhinitis with sleep disorder.\n\nInvestigators invited children aged below 18 years old to the integrative care clinic as experimental group, who have persistent moderate allergic rhinitis, more than 60 scores of the OSA-18 sleep questionnaire, and can accept integrative therapy. The controlled group is patients who receive ordinary western treatment. Investigators compare these two groups by questionnaires of OSA-18,SN-5, PADQLQ,SNAP-IV, the dose of nasal corticosteroid , and polysomnography.\n\nInvestigators hoped to prove the effect of integrative care clinic and to upgrade the quality and efficacy of the treatment among persistent moderate allergic rhinitis children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '0 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age \\<18 years old\n2. ARIA (2014) diagnostic criteria belong to moderate, persistent\n3. OSA-18 score ≥60\n\nExclusion Criteria:\n\n1. cranial-facial anomaly\n2. secondary obstruction sleep apnea due to muscle weakness of upper airway, such as Down syndrome or cerebral palsy\n3. psychiatric disease or behavior disorder\n4. allergy to TCM or ordinary western medicine treatment\n5. asthma'}, 'identificationModule': {'nctId': 'NCT05031793', 'briefTitle': 'Establishing the Collaborative Care Model for Pediatric Allergic Rhinitis With Sleep Disorder', 'organization': {'class': 'OTHER', 'fullName': 'China Medical University Hospital'}, 'officialTitle': 'Establishing the Collaborative Care Model of TCM and Western Medicine for Pediatric Allergic Rhinitis With Sleep Disorder', 'orgStudyIdInfo': {'id': 'CMUH106-REC2-140'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Collaborative Care of TCM and Western Medicine', 'interventionNames': ['Other: TCM', 'Other: Western medicine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Western medicine', 'interventionNames': ['Other: Western medicine']}], 'interventions': [{'name': 'TCM', 'type': 'OTHER', 'description': 'TCM include oral chinese herb, laser acupuncture, tuina, nasal steam inhalation.', 'armGroupLabels': ['Collaborative Care of TCM and Western Medicine']}, {'name': 'Western medicine', 'type': 'OTHER', 'description': 'Western medicine include nasal spray steroid, oral antihistamine', 'armGroupLabels': ['Collaborative Care of TCM and Western Medicine', 'Western medicine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taichung', 'country': 'Taiwan', 'facility': 'China Medical University Hospital', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}], 'overallOfficials': [{'name': 'Hung-Rong Yen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'China Medical University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China Medical University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending physician', 'investigatorFullName': 'Hung-Rong Yen', 'investigatorAffiliation': 'China Medical University Hospital'}}}}