Obstructive Sleep Apnea and Telomere Length

Phase 2

Completed

• Conditions: Obstructive Sleep Apnea

• Registration Number: NCT04872816
• Lead Sponsor: Associação Fundo de Incentivo à Pesquisa

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-05
• Study First Submitted: 2021-04-26
• Study First Submitted QC: 2021-04-29
• Study First Posted: 2021-05-05
• Primary Completion: 2021-06-11
• Study Completion: 2022-04-30
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-05
• Last Update Posted: 2023-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 46

Inclusion Criteria

• body mass index (BMI) of less than 35kg/m2
• age between 35 and 65 years
• diagnosed by laboratory polysomnography with moderate to severe OSA (apnea-hypopnea index, AHI≥20 events/hour of sleep)

Exclusion Criteria

• illiteracy
• participants with more than 50% of the respiratory events obtained in the polysomnography exam being central apneas
• participants with central AHI>5 events/hour of sleep
• participants with sleepiness, measured by the Epworth sleepiness scale≥14
• participants with severe otorhinolaryngological diseases that preclude the use of CPAP (severe nasal septum deviation, severe nasal turbinate hypertrophy, marked palatine and/or adenoid hypertrophy)
• abuse of alcohol or chronic use of psychoactive drugs
• participants with decompensated clinical, neurological or psychiatric illness
• participants with other sleep disorders; participants who had already undergone previous OSA treatments

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change of Leukocyte telomere length from baseline to 6 months	6 months	It will be evaluated the change between leukocyte telomere length before and after the intervention

Secondary Outcome Measures

Name	Time	Method
Change of sleep quality assessed by Pittsburgh Sleep Quality index from baseline to 6 months	6 months	It will be evaluated the change between sleep quality before and after the intervention

Trial Locations

Locations (1)

Universidade Federal de São Paulo; 🇧🇷 São Paulo, Brazil