New ways to measure heart changes in sleep apnea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective observational study aims to characterize endophenotypes of obstructive sleep apnea and associated cardiovascular remodeling using novel metrics such as hypoxic burden, sleep-related heart rate responses, and PWADs. It will examine how these metrics relate to cardiovascular changes and how different therapies (CPAP, MADs, and hypoglossal nerve stimulation) affect cardiovascular parameters. Participants are adults with AHI ≥15, Dutch-speaking, and eligible for their therapy, recruited at Antwerp University Hospital. Central exclusions include significant cardiometabolic disease and prior related therapies that could confound results. The study seeks to broaden understanding beyond traditional AHI-based assessments in OSA.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* AHI ≥ 15 events/hour, based on a recent (\<2 years) PSG, conducted in Antwerp University Hospital
* Patients must be 18 years or older
* Patients must be dutch-speaking
* Patients must be eligible for their therapy (CPAP, MAD or HNS)
* Willing to participate after informed consent

Exclusion Criteria:

* Central apneas accounting for ≥25% of total apneas during baseline polysomnography
* Patients who have received effective CPAP therapy (defined as CPAP use for ≥4 h/night) within the previous 6 months
* Patients with prior MAD therapy
* Uncontrolled hypertension
* Known cardiomyopathy
* Significant coronary arterial disease
* Clinically significant valvular heart disease, defined as more than mild left-sided valvular disease or more than moderate right-sided valvular disease
* Congenital heart disease
* Participants may be excluded if, after rescoring, outcome measures do not meet predefined criteria

Where it's running

• Antwerp University Hospital
  Antwerp, Belgium Recruiting

Study contacts

• Study coordinator: Prof. Marijke Dieltjens
• Email: marijke.dieltjens@uantwerpen.be
• Phone: 038215221

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.