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NCT Number: NCT04872816

Obstructive Sleep Apnea and Telomere Length

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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Key information

Age range

35 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Universidade Federal de São Paulo

São Paulo, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous airway positive pressure

Device

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

Primary outcomes

  1. Change of Leukocyte telomere length from baseline to 6 months

    Time frame: 6 months

    It will be evaluated the change between leukocyte telomere length before and after the intervention

Secondary outcomes

  1. Change of sleep quality assessed by Pittsburgh Sleep Quality index from baseline to 6 months

    Time frame: 6 months

    It will be evaluated the change between sleep quality before and after the intervention

Other outcomes

  1. Change of depressive symptoms assessed by Beck depression inventory from baseline to 6 months

    Time frame: 6 months

    It will be evaluated the change between depressive symptoms before and after the intervention

  2. Change of body mass index from baseline to 6 months

    Time frame: 6 months

    It will be evaluated the change between body mass index before and after the intervention

  3. Change of anxiety symptoms assessed by Anxiety status scale from baseline to 6 months

    Time frame: 6 months

    It will be evaluated the change between anxiety symptoms before and after the intervention

  4. Change of cervical circumference from baseline to 6 months

    Time frame: 6 months

    It will be evaluated the change between cervical circumference before and after the intervention

  5. Change of abdominal circumference from baseline to 6 months

    Time frame: 6 months

    It will be evaluated the change between abdominal circumference before and after the intervention

Sponsors and collaborators

Lead sponsor

Associação Fundo de Incentivo à Pesquisa

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
May 5, 2021
Registry last updated
May 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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