Obstructive Sleep ApneaPhase 2NCT04872816
Obstructive Sleep Apnea and Telomere Length
A Phase 2 study testing Continuous airway positive pressure in people with Obstructive Sleep Apnea, run by Associação Fundo de Incentivo à Pesquisa at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 35 to 65 years, men only
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Continuous airway positive pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Jul 2018to 30 Apr 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Effect of Obstructive Sleep Apnea on Telomere Length and Its Associated Mechanisms
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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Continuous airway positive pressure
- Keywords
- Sleep, Telomere, CPAP
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous airway positive pressureDevice
The continuous airway positive pressure will be used as the gold-standard treatment for obstructive sleep apnea for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Continuous airway positive pressure | Experimental | All participants in continuous airway positive pressure arm will use CPAP (model S10-Resmed®) with expiratory relief and nasal mask. Receives: Device: Continuous airway positive pressure |
| SHAM continuous airway positive pressure | Sham comparator | Individuals in SHAM continuous airway positive pressure arm will use CPAP (model S7-Resmed®) with expiratory relief and nasal mask. The Sham-CPAP consists of a modified CPAP so that the pressure in the mask was less than 1 cm H2O. In this study, the Sham-CPAP equipment includes an increase in the expiratory orifice of the CPAP mask to eliminate airflow resistance, and a resistor with a small orifice was placed between the CPAP and the circuit. The noise produced by the ventilator and the airflow through the mask will be very similar to that of the effective CPAP. The diameter of the expiratory orifice was 10 cm H2O, and a 4 mm diameter resistor was placed between the trachea and the CPAP flow generator. Receives: Device: Continuous airway positive pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (1)
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start5 Jul 2018
- Primary completion11 Jun 2021
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Associação Fundo de Incentivo à Pesquisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Lia Azeredo-Bittencourt, Associação Fundo de Incentivo à Pesquisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872816
- Sponsor's protocol ID
- 0232/2018
- Status last verified
- May 2023
- First submitted
- 26 Apr 2021
- Last updated
- 8 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effect of Obstructive Sleep Apnea on Telomere Length and Its Associated Mechanisms
- ClinicalTrials.gov ID
- NCT04872816
- Acronym / sponsor ID
- 0232/2018
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Sleep, Telomere, CPAP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Associação Fundo de Incentivo à PesquisaUniversity, hospital or other
- Study start
- 5 Jul 2018 (actual)
- Primary completion
- 11 Jun 2021 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 5 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous airway positive pressure | Experimental | Device: Continuous airway positive pressureAll participants in continuous airway positive pressure arm will use CPAP (model S10-Resmed®) with expiratory relief and nasal mask. |
| SHAM continuous airway positive pressure | Sham comparator | Device: Continuous airway positive pressureIndividuals in SHAM continuous airway positive pressure arm will use CPAP (model S7-Resmed®) with expiratory relief and nasal mask. The Sham-CPAP consists of a modified CPAP so that the pressure in the mask was less than 1 cm H2O. In this study, the Sham-CPAP equipment includes an increase in the expiratory orifice of the CPAP mask to eliminate airflow resistance, and a resistor with a small orifice was placed between the CPAP and the circuit. The noise produced by the ventilator and the airflow through the mask will be very similar to that of the effective CPAP. The diameter of the expiratory orifice was 10 cm H2O, and a 4 mm diameter resistor was placed between the trachea and the CPAP flow generator. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuous airway positive pressureThe continuous airway positive pressure will be used as the gold-standard treatment for obstructive sleep apnea for 6 months | Device | Continuous airway positive pressure, SHAM continuous airway positive pressure |
Primary outcome
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
1 secondary outcome
Change of sleep quality assessed by Pittsburgh Sleep Quality index from baseline to 6 months
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Continuous airway positive pressure in people with Obstructive Sleep Apnea, run by Associação Fundo de Incentivo à Pesquisa at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Leukocyte telomere length from baseline to 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2023; AzTrials last refreshed its copy on 30 Oct 2026.