Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-29 @ 5:41 AM
Study NCT ID:
NCT01042834
Status:
COMPLETED
Last Update Posted:
2011-01-13
First Post:
2010-01-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Air Pollution on the Autonomic Nervous System Activity and the Presence of Sleep Apnea in Older Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], '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': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-12', 'studyFirstSubmitDate': '2010-01-05', 'studyFirstSubmitQcDate': '2010-01-05', 'lastUpdatePostDateStruct': {'date': '2011-01-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency analysis of heart rate variability', 'timeFrame': 'inclusion, 1 test night and 2 experimental nights'}], 'secondaryOutcomes': [{'measure': 'Analysis of sleep, diurnal somnolence, sleep latency and PRS impact on the life quality.', 'timeFrame': '1 test night and 2 experimental nights'}, {'measure': 'Hour index quantification of night respiratory events.', 'timeFrame': '1 test night and 2 experimental nights'}, {'measure': 'Hour index quantification of autonomic awakening during the sleep.', 'timeFrame': '1 test night and 2 experimental nights'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['air pollution', 'autonomic nervous system', 'sleep apnea', 'Heart rate variability', 'Healthy volunteers'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Impact of air pollution on the autonomic nervous system activity and presence of sleep apnea in older subjects.', 'detailedDescription': 'The relation between the air pollution and morbidity, cardiovascular mortality was increasing interest. Analyses show an increase of respiratory difficulty, but also cardiac deaths in the daytime when the atmospheric pollution was increased. It was demonstrated that health effects of ambient air pollution in subjects presenting cardiac or lung difficulty were important. Mechanisms show a possible relation to autonomic nervous system (ANS) deactivation and mortality. Particularly, the ageing and ANS reach would be more predictive of cardiovascular events. Thus, we suggest estimating in 60 healthy volunteers from 60 to 80 years old, the impact of the air pollution on the autonomic nervous system activity and sleep apnea consequences.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The subjects will have to live in districts where important atmospheric pollution is established', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* reside in Lyon and Saint-Etienne cities\n* security social affiliated or beneficiary\n* information note signed\n\nExclusion Criteria:\n\n* heart rate disorders\n* pacemaker\n* tabacco addiction or second-hand smoke\n* morbid obesity (BMI \\> 30)\n* insulin-dependent diabetes\n* chronic disease on treatment\n* antiarrythmic treatments'}, 'identificationModule': {'nctId': 'NCT01042834', 'acronym': 'POLLAIR', 'briefTitle': 'Impact of Air Pollution on the Autonomic Nervous System Activity and the Presence of Sleep Apnea in Older Subjects', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Impact of Air Pollution on the Autonomic Nervous System Activity and the Presence of Sleep Apnea in Older Subjects: Longitudinal Multicentric Study', 'orgStudyIdInfo': {'id': '0508078'}, 'secondaryIdInfos': [{'id': 'DGS 2006/0060', 'type': 'OTHER', 'domain': 'AFSSAPS'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Air pollution', 'description': 'The subjects will have to live in districts where important atmospheric pollution is established', 'interventionNames': ['Other: Air pollution study on healthy volunteers.']}], 'interventions': [{'name': 'Air pollution study on healthy volunteers.', 'type': 'OTHER', 'otherNames': ['physiopathologic study'], 'description': 'The subjects are examined three times:\n\n* First the volunteers get used to equipments.\n* Second and third the volunteers sleep in a pollution or purified air.', 'armGroupLabels': ['Air pollution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69000', 'city': 'Lyon', 'country': 'France', 'facility': 'Hospices Civiles de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '42000', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Jean-Claude BARTHELEMY, MD-PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Saint-Etienne'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Clément CAILLAUX', 'oldOrganization': 'Centre Hospitalier Universitaire de Saint-Etienne'}}}}