Prospective Evaluation of New Metrics to Assess Cardiovascular Remodeling in Obstructive Sleep Apnea
Recruiting now
Conditions studied: Obstructive Sleep Apnea, Cardiovascular (CV) Risk
In brief
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.
Key facts
- Study ID
- NCT07427589
- Run by
- University Hospital, Antwerp
- People needed
- 270
- Starts
- 2026-06-10
- Expected to finish
- 2029-12-01
- Last updated by the study team
- 2026-06-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Antwerp University Hospital — Antwerp, Belgium (enrolling)
Full record on ClinicalTrials.gov
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