NCT04872816

Obstructive Sleep Apnea and Telomere Length

Study of the Effect of Obstructive Sleep Apnea on Telomere Length and Its Associated Mechanisms

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Associação Fundo de Incentivo à Pesquisa · Academic / Other
• Sex: Male
• Age: 35 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	Continuous airway positive pressure	The continuous airway positive pressure will be used as the gold-standard treatment for obstructive sleep apnea for 6 months

Timeline

• Start date: 2018-07-05
• Primary completion: 2021-06-11
• Completion: 2022-04-30
• First posted: 2021-05-05
• Last updated: 2023-05-08

Locations

1 site across 1 country: Brazil