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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035903
        • Hospital De Clinicas De Porto Alegre

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Diagnostic test: cortisol, BDNF, s100B, IL-1B, IL-6, IL-10, TNF-alpha
compare both groups and evaluate the severity of obstructive sleep apnea modulates serum levels of inflammatory and neurocognitive markers in elederly.
Other Names:
  • polysomnography
  • Beck Depression Inventory
  • Mini-Mental State Examination (MMSE)
  • WHOQOL-OLD questionnaire
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.
Diagnostic test: cortisol, BDNF, s100B, IL-1B, IL-6, IL-10, TNF-alpha
compare both groups and evaluate the severity of obstructive sleep apnea modulates serum levels of inflammatory and neurocognitive markers in elederly.
Other Names:
  • polysomnography
  • Beck Depression Inventory
  • Mini-Mental State Examination (MMSE)
  • WHOQOL-OLD questionnaire

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Serum level of Brain derived neurotrophic factor
Time Frame: Baseline
Serum of brain-derived neurotrophic factor will be analyzed in the plasma of elderly volunteers using the Sandwich ELISA method.
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Serum level of s100B protein
Time Frame: Baseline
Serum of s100B protein will be analyzed in plasma in elderly volunteers using ELISA method.
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.
Baseline
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.
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.
Baseline
Depression
Time Frame: Baseline
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.
Baseline
Quality of life Score
Time Frame: Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital de Clinicas de Porto Alegre

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ruy S Moraes Filho, PhD, Hospital De Clinicas 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 21, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 11, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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