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Prospective Evaluation of New Metrics to Assess Cardiovascular Remodeling in Obstructive Sleep Apnea

Recruitingn/aAges 18 Years - anyAllUniversity Hospital, Antwerp
NCT07427589 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this prospective study is to gain insight into the endophenotypic variation in OSA, with a focus on the underlying pathophysiological traits and the cardiovascular alterations associated with the condition. To capture the variability in OSA endophenotypes, novel metrics that extend beyond the AHI will be considered, with particular attention to the sleep-apnea-specific hypoxic burden, the sleep-apnea-specific heart rate response, and pulse wave amplitude drops (PWADs). Since the impact of treatment on cardiovascular parameters remains an important point of interest, the effects of different treatment modalities on cardiovascular changes will be investigated, including continuous positive airway pressure (CPAP), mandibular advancement devices (MADs), and hypoglossal nerve stimulation.

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📋 Eligibility rules (as published)
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
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What it tests

  • Continuous positive airway pressure
  • Mandibular advancement device
  • Hypoglossal nerve stimulation
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Where

1 site
Antwerp University Hospital
Antwerp, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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