Obstructive Sleep Apnea and Telomere Length

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04872816
• Other study ID #: 0232/2018
• Status: Completed
• Phase: Phase 2
• Start date: July 5, 2018
• Est. completion date: April 30, 2022

Study information

• Verified date: May 2023
• Source: Associação Fundo de Incentivo à Pesquisa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: April 30, 2022
• Est. primary completion date: June 11, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
Brazil	Universidade Federal de São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Associação Fundo de Incentivo à Pesquisa

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of depressive symptoms assessed by Beck depression inventory from baseline to 6 months	It will be evaluated the change between depressive symptoms before and after the intervention	6 months
Other	Change of body mass index from baseline to 6 months	It will be evaluated the change between body mass index before and after the intervention	6 months
Other	Change of anxiety symptoms assessed by Anxiety status scale from baseline to 6 months	It will be evaluated the change between anxiety symptoms before and after the intervention	6 months
Other	Change of cervical circumference from baseline to 6 months	It will be evaluated the change between cervical circumference before and after the intervention	6 months
Other	Change of abdominal circumference from baseline to 6 months	It will be evaluated the change between abdominal circumference before and after the intervention	6 months
Primary	Change of Leukocyte telomere length from baseline to 6 months	It will be evaluated the change between leukocyte telomere length before and after the intervention	6 months
Secondary	Change of sleep quality assessed by Pittsburgh Sleep Quality index from baseline to 6 months	It will be evaluated the change between sleep quality before and after the intervention	6 months