Cardiovascular (CV) Risk, Obstructive Sleep Apnea
Conditions
Brief summary
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
DEVICEContinuous 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 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.
DEVICEMandibular 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.
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.
Sponsors
University Hospital, Antwerp
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular outcome: interventricular septum thickness | 1 year | Interventricular septal thickness will be assessed via 2D-guided M-mode echocardiographic measurements in the parasternal long-axis view. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sleep apnea-specific hypoxic burden (SASHB) | 1 year | 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. |
| Heart rate response to a respiratory event (ΔHR) | 1 year | 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. |
| Pulse wave amplitude drops (PWADs) | 1 year | 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. |
| Cardiovascular outcome: heart rate variability | 1 year | Heart rate variability will be calculated from ECG-derived RR intervals obtained during the sleep study. |
| Cardiovascular outcome: left ventricular ejection fraction | 1 year | Left ventricular ejection fraction will be assessed via 2D-guided M-mode echocardiographic measurements in the parasternal long-axis view. |
| Cardiovascular outcome: left ventricular mass | 1 year | Left ventricular mass will be assessed via 2D-guided M-mode echocardiographic measurements in the parasternal long-axis view. |
| Cardiovascular outcome: 24-hour ambulatory blood pressure | 1 year | 24-hour ambulatory blood pressure will be measured using ambulatory blood pressure monitoring (ABPM). |
| Cardiovascular outcome: systolic and diastolic function | 1 year | Left ventricular systolic and diastolic function will be evaluated using 2D echocardiography. Systolic function will be quantified by left ventricular ejection fraction calculated using the Simpson biplane method. Diastolic function will be assessed using pulsed wave tissue Doppler imaging at the septal and lateral mitral annulus, mitral inflow velocities (E/A ratio), the E/e' ratio and left atrial volume index. |
| OSA efficacy: delta apnea-hypopnea index (AHI) | 1 year | The apnea-hypopnea Index (AHI), defined as the number of apneas (cessations in breathing) and hypopneas (reductions in airflow) per hour of sleep measured during a polysomnography, will be assessed. OSA is diagnosed when the AHI is at least 5/h. The AHI classifies OSA as mild with AHI ranging from 5 to 14.9 events per hour, moderate with AHI ranging from 15 to 29.9 events per hour and severe when 30 or higher events per hour. |
| Oxygen desaturation index (ODI) | 1 year | The oxygen desaturation index (ODI) represents the number of oxygen desaturation events per hour of sleep, typically defined as a ≥3% or ≥4% drop in arterial oxygen saturation from baseline. |
| Therapy adherence defined by the amount of hours of therapy usage per night and the number of nights per week of use | 1 year | Average hours of therapy use per night and the number of nights per week can be retrieved from data stored in the device. |
| Degree of snoring measured by Visual Analogue Scale (VAS) | 1 year | Visual analogue scale for snoring, from 0 to 10: 0 represents no snoring, 1-3 represents minimally annoying, 4-6 represents moderately annoying, 7-9 represents annoying, and 10 represents extremely annoying. |
| Daytime sleepiness measured by the Epworth Sleepiness Scale (ESS) questionnaire | 1 year | Daytime sleepiness measured using the Epworth sleepiness scale (ESS), which is a self-administered questionnaire that assesses the likelihood of falling asleep in various settings and situations in daily life.The questionnaire consists of eight items scored from 0 to 3, resulting in a total score ranging from 0 to 24. The lowest score (zero) suggests that the described incident is absent and the highest score (three) suggests the presence of this event. |
| Fatigue measured by the Checklist Individual Strength (CIS) questionnaire | 1 year | Fatigue was assessed using the checklist individual strength, a 20-item questionnaire with each item scored on a 7-point Likert scale, resulting in total scores ranging from 20 to 140. Higher scores indicate greater fatigue severity. |
Countries
Belgium
Contacts
CONTACTProf. Marijke Dieltjens
Outcome results
None listed