Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2026-01-29 @ 4:56 AM
Study NCT ID:
NCT03377192
Status:
UNKNOWN
Last Update Posted:
2020-02-13
First Post:
2017-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impedance Pneumography in Assessment of Asthma Control in Preschool Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012135', 'term': 'Respiratory Sounds'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-12', 'studyFirstSubmitDate': '2017-12-05', 'studyFirstSubmitQcDate': '2017-12-13', 'lastUpdatePostDateStruct': {'date': '2020-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Childhood asthma control test (C-ACT)', 'timeFrame': 'Weekly up to maximum 6 months or until loss of asthma control/exacerbation', 'description': 'Questionnaire that measures current asthma control, including 7 questions and a minimum score of 0 and maximum score of 27; score 19 or less indicates that asthma is not controlled.'}], 'secondaryOutcomes': [{'measure': 'Time-to-response (TTR)', 'timeFrame': 'Minimum of 30 days from initiation of anti-asthmatic medication up to max 6 months', 'description': 'Duration from visit 1 to good asthma control (C-ACT\\>19)'}, {'measure': 'Time-to-loss-of-control (TTLOC)', 'timeFrame': 'Minimum of 30 days from initiation of anti-asthmatic medication up to max 6 months', 'description': 'Duration from the visit 2 and 3 until loss of asthma control (C-ACT\\<16) or asthma exacerbation'}, {'measure': 'Lung function', 'timeFrame': 'Every visit up to maximum 6 months', 'description': 'Respiratory resistance and exercise induced increase in resistance, measured by the oscillometric method'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Impedance pneumography', 'Respiratory function', 'Asthma management'], 'conditions': ['Wheezing', 'Asthma in Children']}, 'referencesModule': {'references': [{'pmid': '33819614', 'type': 'DERIVED', 'citation': 'Burman J, Malmberg LP, Remes S, Jartti T, Pelkonen AS, Makela MJ. Impulse oscillometry and free-running tests for diagnosing asthma and monitoring lung function in young children. Ann Allergy Asthma Immunol. 2021 Sep;127(3):326-333. doi: 10.1016/j.anai.2021.03.030. Epub 2021 Apr 2.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the value of impedance pneumography, used as overnight home recordings during a longitudinal design, in assessing asthma control in preschool children', 'detailedDescription': 'Lung function assessment of preschool children is hindered by their limited co-operation in conventional tests such as peak expiratory flow (PEF) or spirometry. However, indices derived from spontaneous tidal respiratory air flow and the shape of tidal expiratory flow-volume and flow-time curves relate to lung function and are easier to record even in young children. As a more advanced approach, the time dynamics and complexity properties of the tidal breathing flow volume (TBFV) signal have been analysed and found to relate to various respiratory conditions.\n\nImpedance pneumography (IP) is a method for measuring changes in the thoracic electrical impedance through skin electrodes, which varies as a function of lung aeration i.e. breathing. Recent technical advancements have enabled IP to be used for accurate non-invasive tidal flow signal measurement. Moreover, in overnight recordings at home, IP was found feasible for quantifying nocturnal TBFV variability in young children with lower respiratory symptoms, showing that preschool children with high risk of asthma present with increased variation of tidal flow profile shape, and momentarily lowered chaoticity, compared to children with lower risk of asthma. So far, there are no studies that have addressed the utility of IP to assess asthma control in young children with asthma.\n\nThe purpose of this study is to investigate the utility of a commercially available IP device (VENTICA, Icare Finland, Finland) and IP-derived clinical indices in assessing the clinical control of asthmatic children receiving normal therapy in a longitudinal setting. The primary hypothesis is that TBFV variability quantified by IP is associated with disease control during management of young children with asthma. The secondary hypothesis is that TBFV variability quantified by IP predicts changes in disease control during management of young children with asthma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '4 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Thirty (30) patients who have attended pediatric ward in the study centre(s) due to asthmatic symptoms (wheeze, cough, dyspnea) will be recruited.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 4-7 years, both sexes\n* Attending pediatric ward in the study centre due to asthmatic symptoms (wheeze, cough and/or dyspnea)\n* History and clinical signs allowing diagnosis of doctor diagnosed asthma and the need to start regular anti-asthmatic medication\n* Signed informed consent\n\nExclusion Criteria:\n\n* Use of inhaled corticosteroid medication 30 days prior to study entry\n* Other cardiorespiratory or neurological chronic diseases or states that may affect breathing\n* Acute respiratory infection 2 weeks prior to study entry\n* Chronic respiratory disorder of prematurity\n* Implanted or external active medical devices'}, 'identificationModule': {'nctId': 'NCT03377192', 'acronym': 'IPAAC', 'briefTitle': 'Impedance Pneumography in Assessment of Asthma Control in Preschool Children', 'organization': {'class': 'OTHER', 'fullName': 'HUS Skin and Allergy Hospital'}, 'officialTitle': 'Impedance Pneumography in Assessment of Asthma Control in Preschool Children', 'orgStudyIdInfo': {'id': 'VCS-002'}}, 'contactsLocationsModule': {'locations': [{'zip': '00029', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'HUS Skin and Allergy Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '00260', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Mehiläinen Paediatric Allergy Clinic', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}], 'overallOfficials': [{'name': 'Pekka Malmberg, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HUS Skin and Allergy Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HUS Skin and Allergy Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Revenio Research', 'class': 'INDUSTRY'}, {'name': 'Mehiläinen', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of clinical physiology', 'investigatorFullName': 'Pekka Malmberg, MD, PhD', 'investigatorAffiliation': 'HUS Skin and Allergy Hospital'}}}}