Inflammation and Neurocognitive Damage Markers in Elderly People With Obstructive Sleep Apnea

NCT04882020 | Unknown

• 1 other identifier: 2019-0529
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructive Sleep Apnea; Sleep Apnea; Apnea, Obstructive; Obstructive Sleep Apnea Syndrome; Inflammation; Inflammatory Response; Neurocognitive Disorders; Neurodegenerative Diseases

Keywords

Obstructive Sleep Apnea; Inflammation; Neurocognitive Damage

Outcome Measures

Primary Outcomes (1)

• Serum level of Brain derived neurotrophic factor

  Serum of brain-derived neurotrophic factor will be analyzed in the plasma of elderly volunteers using the Sandwich ELISA method.

  Baseline

Secondary Outcomes (6)

• Serum level of s100B protein

  Baseline

• Inflammatory markers

  Baseline

• Serum Cortisol levels

  Baseline

• Neurocognitive Damage

  Baseline

• Depression

  Baseline

Study Arms (2)

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

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

Interventions

cortisol, BDNF, s100B, IL-1B, IL-6, IL-10, TNF-alpha DIAGNOSTIC_TEST

compare both groups and evaluate the severity of obstructive sleep apnea modulates serum levels of inflammatory and neurocognitive markers in elederly.

Also known as: polysomnography, Beck Depression Inventory, Mini-Mental State Examination (MMSE), WHOQOL-OLD questionnaire

AHI ≤ 5; AHI ≥ 30

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead
• Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil: collaborator

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035903, Brazil

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma stored at -80ºC in Molecular and Protein Analysis Unit (UAMP) of Hospital de Clínicas de Porto Alegre, Rio Grande do Sul, Brazil. All rates who will not suffer any type of intervention in the studies of the MEDIDAS cohort.

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Inflammation; Neurocognitive Disorders; Neurodegenerative Diseases

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Ruy S Moraes Filho, PhD

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 11, 2021
• Study Start: August 21, 2019
• Primary Completion: April 30, 2021
• Study Completion: June 11, 2021
• Last Updated: May 11, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)