Clinical trial NCT04872816: Obstructive Sleep Apnea and Telomere Length
Official title: Study of the Effect of Obstructive Sleep Apnea on Telomere Length and Its Associated Mechanisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obstructive Sleep Apnea
Keywords: Sleep
Telomere
CPAP
Lead sponsor: Associação Fundo de Incentivo à Pesquisa
Sponsor class: OTHER
First posted: 2021-05-05
Enrollment: 46
Sex: MALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of Leukocyte telomere length from baseline to 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Change of sleep quality assessed by Pittsburgh Sleep Quality index from baseline to 6 months
timeFrame: 6 months
Other outcomes:
measure: Change of depressive symptoms assessed by Beck depression inventory from baseline to 6 months
timeFrame: 6 months
measure: Change of body mass index from baseline to 6 months
timeFrame: 6 months
measure: Change of anxiety symptoms assessed by Anxiety status scale from baseline to 6 months
timeFrame: 6 months
measure: Change of cervical circumference from baseline to 6 months
timeFrame: 6 months
measure: Change of abdominal circumference from baseline to 6 months
timeFrame: 6 months
Locations:
city: São Paulo
country: Brazil
facility: Universidade Federal de São Paulo
Study officials:
References: