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

NCT07427589 | Recruiting DMC

• 2 other identifiers: 4699G063725N
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea; Cardiovascular (CV) Risk

Outcome Measures

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.

  1 year

Secondary Outcomes (14)

• Sleep apnea-specific hypoxic burden (SASHB)

  1 year

• Heart rate response to a respiratory event (ΔHR)

  1 year

• Pulse wave amplitude drops (PWADs)

  1 year

• Cardiovascular outcome: heart rate variability

  1 year

• Cardiovascular outcome: left ventricular ejection fraction

  1 year

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

Antwerp University Hospital

Antwerp, Belgium

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure; Occlusal Splints

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy; Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Central Study Contacts

Prof. Marijke Dieltjens

CONTACT

038215221; marijke.dieltjens@uantwerpen.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 23, 2026
• Study Start: June 10, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: June 29, 2026

Record last verified: 2026-01

Locations

BE (1)