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

Key facts

Who runs it
University Hospital, Antwerp
Where
Belgium1 site in 1 countryChoose a country to see its sites
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

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Record updated
29 June 2026