NCT04872816

Obstructive Sleep Apnea and Telomere Length

Completed Phase 2 Last updated 8 May 2023

What this trial tests

Phase 2 trial testing Continuous airway positive pressure in Obstructive Sleep Apnea in 46 participants. Completed in 30 April 2022.

Timeline

5 July 2018

Primary endpoint
11 June 2021

30 April 2022

Quick facts

Lead sponsor	Associação Fundo de Incentivo à Pesquisa
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	46
Start date	5 July 2018
Primary completion	11 June 2021
Estimated completion	30 April 2022
Sites	1 location across Brazil

Drugs / interventions tested

• Continuous airway positive pressure

Conditions studied

• Obstructive Sleep Apnea — all drugs for Obstructive Sleep Apnea →

Sponsor

Associação Fundo de Incentivo à Pesquisa — full company profile →

Who can join

Adults 35 to 65, male only, with Obstructive Sleep Apnea. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effect of Obstructive Sleep Apnea and CPAP on Telomere Length and Its Associated Mechanisms: A Pilot Study.
   Tempaku PF, D'Almeida V, da Silva SMA, Bittencourt L, et al · · 2026 · PMID 41840472 · DOI 10.1177/15491684261428017