Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:16 AM
Study NCT ID:
NCT04882020
Status:
UNKNOWN
Last Update Posted:
2021-05-11
First Post:
2021-05-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Inflammation and Neurocognitive Damage Markers in Elderly People With Obstructive Sleep Apnea
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}, {'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}], '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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017286', 'term': 'Polysomnography'}], 'ancestors': [{'id': 'D008991', 'term': 'Monitoring, Physiologic'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma stored at -80ºC in Molecular and Protein Analysis Unit (UAMP) of Hospital de Clínicas de Porto Alegre, Rio Grande do Sul, Brazil.\n\nAll rates who will not suffer any type of intervention in the studies of the MEDIDAS cohort.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-08-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-06-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-10', 'studyFirstSubmitDate': '2021-05-05', 'studyFirstSubmitQcDate': '2021-05-10', 'lastUpdatePostDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum level of Brain derived neurotrophic factor', 'timeFrame': 'Baseline', 'description': 'Serum of brain-derived neurotrophic factor will be analyzed in the plasma of elderly volunteers using the Sandwich ELISA method.'}], 'secondaryOutcomes': [{'measure': 'Serum level of s100B protein', 'timeFrame': 'Baseline', 'description': 'Serum of s100B protein will be analyzed in plasma in elderly volunteers using ELISA method.'}, {'measure': 'Inflammatory markers', 'timeFrame': 'Baseline', 'description': 'The serum levels of cytokines (IL-1b, IL-6, IL-10 and TNF-alpha) will be analyzed in the plasma of elderly volunteers. The serum level of cytokines using a unit multiplex assay in pg/mL.'}, {'measure': 'Serum Cortisol levels', 'timeFrame': 'Baseline', 'description': 'Serum cortisol levels will be analyzed in the plasma of elderly volunteers. The serum level of cortisol will be quantified by chemiluminescence microparticle immunoassay (CMIA) with reference values for blood collection performed in the morning shift from 3.7 to 19.4 ug / dL.'}, {'measure': 'Neurocognitive Damage', 'timeFrame': 'Baseline', 'description': 'Neurocognitive damage will be measured by the Mini Mental State Examination adapted for the Brazilian population. The maximum score for this scale is 30 points, indicating better cognitive performance. A score of 0-9 points indicates severe cognitive loss; 10-20 points of moderate cognitive loss; 21-26 points mild cognitive loss, 27-30 points without cognitive loss.'}, {'measure': 'Depression', 'timeFrame': 'Baseline', 'description': 'Depression will be measured by the Beck Depression Inventory. A score of 0-9 points indicates that the individual is not depressed; 10-18 points mild depression; 19-29 points moderate depression; 30-36 points severe depression.'}, {'measure': 'Quality of life Score', 'timeFrame': 'Baseline', 'description': "Quality of life will be measured using the World Health Organization's Quality of Life questionnaire, which has assessments in the domains: physical, psychological, social relations and the environment. The evaluation of each domain is expressed as a percentage, where the higher the result (100%) indicates the better quality of life in the respective domain. The general quality of life is given by the average of the scores of the four domains, whose scores vary from 0 to 5 points. 1-2.9 points the quality of life needs to improve; 3-3.9 regular quality of life; 4-4.9 good quality of life; 5 very good quality of life."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obstructive Sleep Apnea', 'Inflammation', 'Neurocognitive Damage'], 'conditions': ['Obstructive Sleep Apnea', 'Sleep Apnea', 'Apnea, Obstructive', 'Obstructive Sleep Apnea Syndrome', 'Inflammation', 'Inflammatory Response', 'Neurocognitive Disorders', 'Neurodegenerative Diseases']}, 'descriptionModule': {'briefSummary': 'The aging process tends to promote an overall increase in inflammation compromising the immunologic system regulation, sleep/wakefulness pattern, and neurocognitive performance. In elders, there is an increase in repetitive arousals during sleep, secondary to breathing interruption by pharynx collapse, generating a transient reduction in oxygen delivery to the brain known as obstructive sleep apnea. This lack in oxygen supply results in an inflammatory process producing brain damage. Some substances present in the blood seem to be associated to neurocognitive damage, like S100β protein, cortisol, interleukin 1-β,6 and TNF-α. In the other way, a substance called brain-derived neurotrophic factor (BDNF) enhances cognitive function, and memory consolidation improvement.', 'detailedDescription': 'An intermittent hypoxia in obstructive sleep apnea induces the production of reactive oxygen species (ROS), oxidative damage and inflammation generating pro-inflammatory cytokines, reactive gliosis and neuronal damage. The increase in oxidative damage seems to be associated to age, contributing to the progress of neurodegeneration. Transient hypoxemia leads to autonomic excitation causing hyperactivity of the sympathetic nervous system (SNS), and activation of the hypothalamic-pituitary-adrenal (HPA) axis, causing immunological changes and increased risk of damage to mental functions. Night awakenings caused by OSA are associated with changes on the HPA axis, resulting in increased serum cortisol levels. The fluctuation in serum cortisol levels at night is intrinsically related to sleep, and increases with advancing age. BDNF is responsible for increasing the growth of neurites, and synaptogenesis, preventing programmed cell death in adults, and is involved in stress responses on the HPA axis. Low BDNF levels are associated to cognitive impairment, less memory consolidation, depression, and OSA. There is a positive correlation between levels of BDNF and cortisol related to physiological regulation of brain activities. The increase in oxidative damage caused by intermittent hypoxia during obstructive sleep apnea increases serum levels of the s100β protein promoting reactive gliosis or astrogliosis being associated to depression in the elderly. Obstructive sleep apnea syndrome is associated with development of cardiovascular and neurological diseases by activating pro-inflammatory pathways. However, in elderly individuals, regardless of other specific pathologies, they already have a pro-inflammatory state secondary to loss of regulation of the immune system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A sample will be composed from the database and the biorepository of volunteers participating in the MEDIDAS cohort study. The database was stored in the Non-Invasive Methods Unit (UMNI) and the biorepository of blood aliquots initiated at -80ºC in the Molecular and Protein Analysis Unit (UAMP) in Hospital de Clínicas de Porto Alegre, Brazil. All data and aliquots will not suffer any type of intervention in the studies of the MEDIDAS cohort.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria:\n\n* Individuals aged 65 to 80;\n* both sexes;\n* free and informed consent form previously signed for participation in the MEDIDAS cohort study;\n* previous performance of outpatient polysomnography with adequate technical quality\n* AHI ≤ 5 or ≥ 30 events/hour;\n* previous blood collection between 7-9 am; questionnaires.\n\nExclusion criteria:\n\n* Have had treatment for sleep apnea;\n* suffer from rheumatic or chronic diseases such as diabetes mellitus, heart failure, coronary artery disease, chronic renal failure or nephropathy (creatinine\\> 1.8 mg / dL), liver disease, history of stroke, aortic aneurysm, marked elevation in blood arterial pressure (\\> 180/110 mmHg), assessed by 24-hour ambulatory blood pressure monitoring (ABPM);\n* cognitive deficit verified in the Mini Mental State Examination;\n* diagnosis of Alzheimer's and Parkinson's."}, 'identificationModule': {'nctId': 'NCT04882020', 'briefTitle': 'Inflammation and Neurocognitive Damage Markers in Elderly People With Obstructive Sleep Apnea', 'organization': {'class': 'OTHER', 'fullName': 'Hospital de Clinicas de Porto Alegre'}, 'officialTitle': 'Inflammation and Neurocognitive Damage Markers in Elderly People With Obstructive Sleep Apnea', 'orgStudyIdInfo': {'id': '2019-0529'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'AHI ≤ 5', 'description': 'Individuals aged 65 to 80; both sexes; Informed Consent Form with prior signature for participation in the MEDIDAS cohort study; previous performance of ambulatory polysomnography with adequate technical quality and AHI ≤ 5 events / hour; prior blood collection between 7-9 am and questionnaires.', 'interventionNames': ['Diagnostic Test: cortisol, BDNF, s100B, IL-1B, IL-6, IL-10, TNF-alpha']}, {'label': 'AHI ≥ 30', 'description': 'Individuals aged 65 to 80; both sexes; Informed Consent Form with prior signature for participation in the MEDIDAS cohort study; previous performance of ambulatory polysomnography with adequate technical quality and AHI ≥ 30 events / hour; prior blood collection between 7-9 am and questionnaires.', 'interventionNames': ['Diagnostic Test: cortisol, BDNF, s100B, IL-1B, IL-6, IL-10, TNF-alpha']}], 'interventions': [{'name': 'cortisol, BDNF, s100B, IL-1B, IL-6, IL-10, TNF-alpha', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['polysomnography', 'Beck Depression Inventory', 'Mini-Mental State Examination (MMSE)', 'WHOQOL-OLD questionnaire'], 'description': 'compare both groups and evaluate the severity of obstructive sleep apnea modulates serum levels of inflammatory and neurocognitive markers in elederly.', 'armGroupLabels': ['AHI ≤ 5', 'AHI ≥ 30']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90035903', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital de Clínicas de Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'overallOfficials': [{'name': 'Ruy S Moraes Filho, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital de Clínicas de Porto Alegre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital de Clinicas de Porto Alegre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}