Prospective Evaluation of New Metrics to Assess Cardiovascular Remodeling in Obstructive Sleep Apnea
Key facts
- Who runs it
- University Hospital, Antwerp
- Where
- Antwerp, BelgiumSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 270 people, planned
- Started
- 10 Jun 2026
- Expected to end
- Dec 2029
- Type of study
- Observational
- Treatments tested
- Continuous positive airway pressure
- Mandibular advancement device
- Hypoglossal nerve stimulation
- Record updated
- 29 June 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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
- Central apneas accounting for ≥25% of total apneas during baseline polysomnography
- Known cardiomyopathy
- Participants may be excluded if, after rescoring, outcome measures do not meet predefined criteria
Where in Belgium
- Antwerp University HospitalAntwerp, BelgiumContact: Prof. Marijke DieltjensTaking people
About the trial
What the trial wants to find out
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.
Treatments tested
- Continuous positive airway pressure
- Mandibular advancement device
- Hypoglossal nerve stimulation
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 29 June 2026