- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04882020
Inflammation and Neurocognitive Damage Markers in Elderly People With Obstructive Sleep Apnea
May 10, 2021 updated by: Hospital de Clinicas de Porto Alegre
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Observational
Enrollment (Actual)
76
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brazil, 90035903
- Hospital de Clínicas de Porto Alegre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 80 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
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.
Description
Inclusion criteria:
- Individuals aged 65 to 80;
- both sexes;
- free and informed consent form previously signed for participation in the MEDIDAS cohort study;
- previous performance of outpatient polysomnography with adequate technical quality
- AHI ≤ 5 or ≥ 30 events/hour;
- previous blood collection between 7-9 am; questionnaires.
Exclusion criteria:
- Have had treatment for sleep apnea;
- 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);
- cognitive deficit verified in the Mini Mental State Examination;
- diagnosis of Alzheimer's and Parkinson's.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
AHI ≤ 5
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.
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compare both groups and evaluate the severity of obstructive sleep apnea modulates serum levels of inflammatory and neurocognitive markers in elederly.
Other Names:
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AHI ≥ 30
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.
|
compare both groups and evaluate the severity of obstructive sleep apnea modulates serum levels of inflammatory and neurocognitive markers in elederly.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum level of Brain derived neurotrophic factor
Time Frame: Baseline
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Serum of brain-derived neurotrophic factor will be analyzed in the plasma of elderly volunteers using the Sandwich ELISA method.
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Baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum level of s100B protein
Time Frame: Baseline
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Serum of s100B protein will be analyzed in plasma in elderly volunteers using ELISA method.
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Baseline
|
Inflammatory markers
Time Frame: Baseline
|
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.
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Baseline
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Serum Cortisol levels
Time Frame: Baseline
|
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.
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Baseline
|
Neurocognitive Damage
Time Frame: Baseline
|
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.
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Baseline
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Depression
Time Frame: Baseline
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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.
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Baseline
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Quality of life Score
Time Frame: Baseline
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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.
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Baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ruy S Moraes Filho, PhD, Hospital de Clínicas de Porto Alegre
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 21, 2019
Primary Completion (Actual)
April 30, 2021
Study Completion (Anticipated)
June 11, 2021
Study Registration Dates
First Submitted
May 5, 2021
First Submitted That Met QC Criteria
May 10, 2021
First Posted (Actual)
May 11, 2021
Study Record Updates
Last Update Posted (Actual)
May 11, 2021
Last Update Submitted That Met QC Criteria
May 10, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Respiratory Tract Diseases
- Respiration Disorders
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Signs and Symptoms, Respiratory
- Sleep Apnea Syndromes
- Sleep Apnea, Obstructive
- Inflammation
- Apnea
- Neurodegenerative Diseases
- Neurocognitive Disorders
- Anti-Inflammatory Agents
- Hydrocortisone
Other Study ID Numbers
- 2019-0529
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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