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Recruiting NCT07427589

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

— Observational Obstructive Sleep Apnea Cardiovascular (CV) Risk

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Continuous positive airway pressure, Mandibular advancement device, Hypoglossal nerve stimulation.
Who it may be relevant to
Registry conditions: Obstructive Sleep Apnea, Cardiovascular (CV) Risk. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device Continuous positive airway pressure
    CPAP remains the most commonly used treatment modality and is considered as the gold standard for patients with OSA because of its high efficacy and noninvasive nature. CPAP therapy is indicated for patients with moderate to severe OSA (AHI ≥ 15/h) or for those with a lower AHI with symptoms of excessive daytime sleepiness. It is effective in reducing nocturnal obstructive events by delivering continuous positive airway pressure, which functions as a pneumatic splint to keep the upper airway ope
  • Device Mandibular advancement device
    Mandibular advancement device (MAD) has become a widely recognized non-invasive treatment alternative for patients who cannot tolerate CPAP. It is primarily indicated for mild to moderate OSA and lately also for severe OSA patients. These MADs are worn intraorally during the night and attach to both upper and lower dental arches, protrude the lower jaw to widen and reopen the upper airway.
  • Device Hypoglossal nerve stimulation
    Hypoglossal nerve stimulation (HNS) is a novel and unique therapeutic option for patients with moderate-to-severe OSA who cannot be treated effectively with CPAP or MAD. In contrast to traditional reconstructive procedures for OSA, which focus only on anatomical adjustments, HNS integrates a surgical implantation process with an adjustable medical device to open the upper airway through neuromodulation of the hypoglossal nerve.

Primary outcome measures

  • Cardiovascular outcome: interventricular septum thickness [Time frame: 1 year]
Secondary outcome measures (12)
  • Sleep apnea-specific hypoxic burden (SASHB) [Time frame: 1 year]
  • Heart rate response to a respiratory event (ΔHR) [Time frame: 1 year]
  • Pulse wave amplitude drops (PWADs) [Time frame: 1 year]
  • Cardiovascular outcome: heart rate variability [Time frame: 1 year]
  • Cardiovascular outcome: left ventricular ejection fraction [Time frame: 1 year]
  • Cardiovascular outcome: left ventricular mass [Time frame: 1 year]
  • Cardiovascular outcome: 24-hour ambulatory blood pressure [Time frame: 1 year]
  • Cardiovascular outcome: systolic and diastolic function [Time frame: 1 year]
  • OSA efficacy: delta apnea-hypopnea index (AHI) [Time frame: 1 year]
  • Oxygen desaturation index (ODI) [Time frame: 1 year]
  • Therapy adherence defined by the amount of hours of therapy usage per night and the number of nights per week of use [Time frame: 1 year]
  • Degree of snoring measured by Visual Analogue Scale (VAS) [Time frame: 1 year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Belgium · 1 center
  • Antwerp University Hospital — Antwerp

Identifiers

NCT: NCT07427589 · 4699 · G063725N

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗