Prospective Evaluation of New Metrics to Assess Cardiovascular Remodeling in Obstructive Sleep Apnea
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Antwerp
About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Continuous positive airway pressure
- Mandibular advancement device
- Hypoglossal nerve stimulation
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov