Health TrialsbyHealthPanel

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

ConditionsObstructive Sleep ApneaCardiovascular (CV) Risk
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

This trial does not accept healthy volunteers

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 population

The study population consists of patients diagnosed with moderate to severe obstructive sleep apnea (OSA) (AHI≥15/h), recruited by the OSA multidisciplinary team.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Continuous positive airway pressure

    Device

    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 open and prevent pharyngeal collapse during sleep \[16\]. CPAP therapy generally improves sleep parameters, enhances blood oxygen saturation and causes disappearing of OSA-related symptoms. Although CPAP is really effective in treating OSA, many patients struggle with intolerance and long-term adherence remains a significant challenge.

  • Mandibular advancement device

    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.

  • Hypoglossal nerve stimulation

    Device

    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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Cardiovascular outcome: interventricular septum thickness

Interventricular septal thickness will be assessed via 2D-guided M-mode echocardiographic measurements in the parasternal long-axis view.

Time frame
1 year

Secondary outcomes

1

Sleep apnea-specific hypoxic burden (SASHB)

This novel metric is calculated by determining the total area under the respiratory event-related desaturation curve, which can be obtained from a polysomnography (PSG). It has been shown to be a good predictor of cardiovascular disease mortality, but has not yet been established in daily practice.

Time frame
1 year
2

Heart rate response to a respiratory event (ΔHR)

ΔHR is defined as the difference between the maximum pulse rate after airway opening, i.e. during a subject-specific search window, and an event-related minimum pulse rate, i.e. minimum pulse rate during respiratory events. ΔHR will be calculated from a photoplethysmography (PPG), a signal derived from a finger pulse oximeter, which is part of the standard clinical PSG set-up.

Time frame
1 year
3

Pulse wave amplitude drops (PWADs)

PWADs can be calculated from photoplethysmography (PPG), a signal derived from a finger pulse oximeter, which is part of the standard clinical PSG set-up.

Time frame
1 year
4

Cardiovascular outcome: heart rate variability

Heart rate variability will be calculated from ECG-derived RR intervals obtained during the sleep study.

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Antwerp

Lead sponsor

Source ClinicalTrials.gov
Apply now