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Clinical Trials in Belgium / NCT06915077
Enrolling by invitation Observational

Personalised Treatment for OSA

NCT06915077 · tracked via the Priya Life Science Belgium tracker
Sponsor
University Hospital, Antwerp
Phase
Observational
Started
2025-04-28
Last updated
2025-06-26

Condition(s) studied

Sleep Apnea Syndrome (OSAS)Sleep Apnea SyndromeSleep Apnea Syndrome, ObstructiveSleep Apnea/Hypopnea SyndromeSleep Apnea

Study summary

Obstructive sleep apnea (OSA) is a sleep disorder characterized by repetitive episodes of partial or complete obstruction of the upper airway during sleep. Continuous positive airway pressure (CPAP) is a method used as a first-line treatment for obstructive sleep apnea (OSA). However, intolerance and resistance to CPAP can limit its long-term effectiveness. Alternative treatments are available, such as Mandibular Advancement Devices (MADs), positional therapy, upper airway surgery, and maxillomandibular osteotomy. However, often less efficient in reducing the apnea-hypopnea index, the higher tolerance of and compliance to alternative treatment has resulted in the adequate treatment of OSA in CPAP-intolerant patients. This paper describes the protocol of a prospective single-center cohort study including adult patients with moderate to severe OSA (15 events/h ≤ apnea-hypopnea index (AHI) \< 65 events/h) that failed to comply with CPAP therapy. Selected patients will be invited to the clinic to explore alternative treatment options where DISE will be a first step in further identifying upper airway collapse during sleep. By exploring alternative treatment options in CPAP-intolerant patients and systematically documenting their treatment paths, an algorithm can be defined to better guide patients towards personalized treatment for OSA. The follow-up is aimed at 5 years with an inclusion of 170 patients per year, including a drop-out rate of 15%. By leveraging a real-world database, this study aims to bridge the gap between research and clinical practice, facilitating the development of evidence-based guidelines and personalized treatment algorithms for CPAP-intolerant patients.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * adult patients (age starting from 18 years old) * moderate to severe OSA (AHI ≥ 15/h) * CPAP-intolerant or non-compliant * willing to explore alternative treatment options Exclusion Criteria: * patients who are still on CPAP therapy * pediatric patients * newly diagnosed patients who have not had CPAP before * patients with AHI ≥ 65 events/h.

Primary outcome measure(s)

  • Apnea-hypopnea index (AHI) as measured by a poly(somno)graphy — From baseline to 3 and 12 months
    The AHI is an index of sleep apnea severity that encompasses the frequency of apneas (cessations in breathing) and hypopneas (reductions in airflow) per hour of sleep.

Trial sites (1)

FacilityCityRegionStatus
Universiteit Antwerpen Wilrijk Antwerpen

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Other trials for the same condition

Hypoglossal Nerve Stimulation Therapy in Patients With Obstructive Sleep Apnea: Belgian Registry Recruiting
Validation of the Diagnostic Performance of the Sleep Apnea Syndrome by the Withings HWA09 Device Active, not recruiting
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06915077 on ClinicalTrials.gov ↗ ← All trials in Belgium