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临床试验/NCT06915077
NCT06915077Enrolling By Invitation不适用

Personalized Treatment for Obstructive Sleep Apnea: Beyond CPAP

University Hospital, Antwerp1 个研究点 分布在 1 个国家目标入组 850 人开始时间: 2025年4月28日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
850
试验地点
1
主要终点
Apnea-hypopnea index (AHI) as measured by a poly(somno)graphy

研究概览

简要总结

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.

详细描述

Obstructive sleep apnea (OSA) is a sleep disorder characterized by repetitive episodes of partial or complete obstruction of the upper airway during sleep, leading to reduced or completely stopped airflow despite ongoing respiratory efforts. This results in disrupted sleep and intermittent hypoxia. This disorder is estimated to affect 17% of middle-aged women and 34% of middle-aged men [1]. Loud snoring, a precursor of OSA, is even more prevalent and is estimated to affect 40-60% of adult people [2]. OSA does not only cause symptoms such as excessive daytime sleepiness, loud snoring, and interrupted breathing during sleep. OSA can have significant health implications, including increased risk of hypertension, cardiovascular disease, and impaired cognitive function in the long term, as shown in several scientific studies [3,4,5]. Although 80% of patients remain undiagnosed, increasing awareness is seen over the last years [6].

OSA is diagnosed with an overnight polysomnography in a hospital setting or at home, in patients who are clinically and anamnestically suspected of OSA. Symptoms are habitual snoring, choking or gasping during sleep, excessive daytime sleepiness, inattention, and poor recall. Severity of OSA is measured using the apnea-hypopnea index (AHI), the number of apneas and hypopneas per hour of sleep. The diagnosis is confirmed if the AHI is at least five events per hour of sleep. Severity based on AHI is defined as follows: mild OSA (5 < AHI ≤ 15/h), moderate OSA (15 < AHI < 30/h) and severe OSA (AHI ≥ 30/h) [7].

Continuous positive airway pressure (CPAP) is a method used as first-line treatment for OSA. CPAP therapy significantly reduces disease severity, sleepiness, blood pressure, and sleepiness-related traffic accident occurrence, as well as improves the sleep-related quality of life in adults with sleep apnea [8].

However, intolerance and resistance to CPAP can limit its long-term effectiveness. Various factors contribute to CPAP intolerance, including mask discomfort, claustrophobia, nasal congestion, air leaks, pressure intolerance, and difficulty adjusting to the therapy [9]. Compliance failure is reported to be different in various countries. A recent nation-wide French database study showed that almost half of patients on CPAP therapy terminate the CPAP treatment after three years [10]. Therefore, alternative treatment options in CPAP-intolerant or non-compliant patients have gain increased interest and importance in daily practice, leading us towards a more personalized way of treatment.

Alternative treatments for OSA include Mandibular Advancement Devices (MADs), positional therapy, upper airway surgery, and maxillomandibular osteotomy [11,12,13,14]. MAD therapy has emerged as a second-line conservative non-invasive treatment method for the management of mild to moderate OSA, and lately even for severe OSA patients. MAD therapy consists of a titratable duo-block with separate upper and lower parts that are dynamically interconnected. This allows for a gradual protrusion of the lower jaw until the optimal position is reached. As such, patients can optimize the ideal position that allows symptoms (such as snoring and tiredness) to disappear and to tolerate protrusion as well. MAD therapy functions on increasing the upper airway volume, mainly the widening of the lateral walls of the velopharynx [15].

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • patients who are still on CPAP therapy
  • pediatric patients
  • newly diagnosed patients who have not had CPAP before
  • patients with AHI ≥ 65 events/h.

结局指标

主要结局

Apnea-hypopnea index (AHI) as measured by a poly(somno)graphy

时间窗: 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.

次要结局

  • Reason for CPAP intolerance(At baseline)
  • Daytime sleepiness measured by the Epworth Sleepiness Scale (ESS) questionnaire(From baseline to 3 and 12 months)
  • Disease-specific quality of life as measured by the Functional Outcomes of Sleep Questionnaire-30 (FOSQ-30) questionnaire(From baseline to 3 and 12 months)
  • Degree of snoring measured by the Visual Analogue Scale (VAS) questionnaire(From baseline to 3 and 12 months)
  • DISE-score during baseline DISE(At baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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