Universidade Federal de São Paulo
São Paulo, Brazil
NCT Number: NCT04872816
Obstructive sleep apnea (OSA) is a highly prevalent and morbid sleep disorder. Among the factors associated with its pathophysiology, the role of intermittent hypoxia stands out, contributing to the development of oxidative stress and inflammation. It is known that cumulative levels of these factors negatively influence the final portion of the DNA, known as telomere. In this sense, the investigators hypothesize that OSA is capable of accelerating aging process through telomere shortening mediated by inflammatory and oxidative markers. Thus, the aim of this study is to investigate the effect of OSA and its treatment with CPAP on the variation of telomere length and their associated mechanisms. For this, a randomized, double-blind, sham-controlled clinical study with 6 months duration will be conducted. We will recruit male participants with OSA diagnosis (apnea-hypopnea indexe15/hour), aged between 35-65 years and body mass index<35 kg/m2, which will be randomized to use CPAP or sham-CPAP for 6 months. Participants will visit the laboratory 7 times (baseline and after 1, 2, 3, 4, 5 and 6 months) and will be submitted to clinical and otorhinolaryngological evaluation, sleep questionnaires, polysomnography and blood collection for DNA and extraction and measurement of telomere length, as well as the expression of telomerase and oxidative and inflammatory markers (ADMA, homocysteine, cysteine, TBARS, 8-oxodG, TNF-a, IL-6 and IL-10). This project aims to contribute to the elucidation of the effect of OSA on telomere length maintenance, as well as the adjacent mechanisms to this relationship.
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Notify Me35 year–65 year
Male
Interventional
Phase 2
São Paulo, Brazil
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The continuous airway positive pressure will be used as the gold-standard treatment for obstructive sleep apnea for 6 months
Time frame: 6 months
It will be evaluated the change between leukocyte telomere length before and after the intervention
Time frame: 6 months
It will be evaluated the change between sleep quality before and after the intervention
Time frame: 6 months
It will be evaluated the change between depressive symptoms before and after the intervention
Time frame: 6 months
It will be evaluated the change between body mass index before and after the intervention
Time frame: 6 months
It will be evaluated the change between anxiety symptoms before and after the intervention
Time frame: 6 months
It will be evaluated the change between cervical circumference before and after the intervention
Time frame: 6 months
It will be evaluated the change between abdominal circumference before and after the intervention
Associação Fundo de Incentivo à Pesquisa
Other
Study of the Effect of Obstructive Sleep Apnea on Telomere Length and Its Associated Mechanisms
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