By InvitationNot Applicable

Intermitent Hypoxia and Its Pathophysiology Consequences in the Sleep Apnea-Hypopnea Syndrome.

Spain130 participantsStarted 2020-07-20

Plain-language summary

Clinical trial on the effect of continuous positive pressure (CPAP). Objectives: 1) To assess the total or partial recovery of oxidative and inflammatory damage after recovering IH. 2) To check whether the results obtained in vitro on the recovery of the damage according to the form of manifestation of IH are validated in SAHS patients. 3) To determine if CPAP reduces nighttime blood pressure and arterial stiffness depending on whether or not patients have a non-dipping pattern of blood pressure and depending on the degree of correction of IH. 4) To clarify whether residual nocturnal hypoxemia influences the recovery of oxidative and inflammatory damage in patients. 5) To determine nasal and intestinal microbioma and the effect of CPAP treatment

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Cases: patients with AHI \> 30 * Controls: subjects with AHI \< 5 and Epworth \>10 Exclusion Criteria: * Epworth\>18 * BMI\<40Kg/M2 * Arterial Hypertension * Mellitus Diabetes * Cerebrovascular disease * Ischemic heart disease * Cardiac arrhythmia * Chronic cardiovascular diseases * Daytime Oxygen saturation\>95% * Risk professions (professional drivers) * Concomitant treatment with antihypertensives, statins, antidiabetics, beta-blockers or systemics corticosteroids. * Pretreatment with CPAP. * Participation in another clinical trial thirty days prior to randomization

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline in 8 isoprostane levels

Timeframe: 4 months

Change from baseline in microbiota population diversity from stool samples

Timeframe: 4 months

Change from baseline in microbiota population diversity from nasopharyngeal samples

Timeframe: 4 months

Change from baseline in microbiota population abundance from stool samples

Timeframe: 4 months

Change from baseline in microbiota population abundance from nasopharyngeal samples

Timeframe: 4 months

Change from baseline in microbiota population color maps from stool samples

Timeframe: 4 months

Change from baseline in microbiota color maps from nasopharyngeal samples

Timeframe: 4 months

Trial details

NCT IDNCT04444778

SponsorAlberto Alonso Fernandez

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2025-04-16

View on ClinicalTrials.gov More Sleep Apnea, Obstructive trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change from baseline in 8 isoprostane levels

Timeframe: 4 months

Change from baseline in microbiota population diversity from stool samples

Timeframe: 4 months

Change from baseline in microbiota population diversity from nasopharyngeal samples

Timeframe: 4 months

Change from baseline in microbiota population abundance from stool samples

Timeframe: 4 months

Change from baseline in microbiota population abundance from nasopharyngeal samples

Timeframe: 4 months

Change from baseline in microbiota population color maps from stool samples

Timeframe: 4 months

Change from baseline in microbiota color maps from nasopharyngeal samples

Timeframe: 4 months