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临床试验/NCT03924817
NCT03924817进行中(未招募)不适用

Registry Study on Prescription, Patient Pathways, Therapy Efficacy and Usage of Mandibular Advancement Devices in Obstructive Sleep Apnea - PATT-OSA Registry

ResMed4 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2024年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
500
试验地点
4
主要终点
Changes of the Apnoea-Hypopnea-Index (AHI) at baseline compared to a follow-up after 3 months

研究概览

简要总结

During sleep, the muscle tonus in the oropharyngeal space is lost, the tongue might fall back andthe volume of the pharynx decreases. Air cannot pass through as it would in the awake state and thus airflow limitations occur. The person asleep might compensate the flow limitation by breathing faster, which causes the soft tissue to vibrate (= snoring). Further narrowing of the airways can lead to obstructive apneas (complete airway collapse and stopping of airflow). First line therapy for obstructive sleep apnea (OSA) is positive airway pressure (PAP) that keeps the airways open with a pneumatic splint. Since PAP involves wearing a facial mask that applies air pressure into the airways, some patients cannot tolerate this therapy. These patients might be candidates for an alternative treatment approach with a mandibular advancement device (MAD).

详细描述

During sleep, the muscles in the oropharyngeal space relax, the tongue falls back and the volume of the pharynx decreases. Air cannot pass through as it would in the awake state and thus airflow limitations occur. Diminishing airflow can lead to snoring or to the airways collapsing completely (obstructive sleep apnea, OSA). Patients who suffer from OSA have trouble breathing during sleep and will have a disturbed sleep architecture as repeated airway closure causes wake reactions and arousals. This does not only lead to severe daytime sleepiness with high risk of causing car accidents, for instance, but also affects synaptic activity during sleep and the balance of blood gas levels. These factors can have a aggravating effect on blood pressure and worsen the prognosis for cardiovascular comorbidities. First line therapy for obstructive sleep apnea (OSA) is positive airway pressure (PAP) that keeps the airways open with a pneumatic splint. Positive airway pressure is being applied through a facial mask and some patients cannot tolerate this therapy or refuse it. An alternative treatment approach is by fitting an MAD that the patient wears during sleep. An MAD pushes the lower jar forward and thereby increases the volume of the upper airways, thus preventing them to close. Studies have shown good compliance with MAD therapy and benefits in terms of sleepiness and quality of life. The Narval registry study aims to investigate MAD usage in real life and reasons for non-compliance. The registry aims to record patient characteristics (e.g. comorbidities) and side effects that lead to a termination of therapy, but also how the costs for therapy are split between the patient and public or private health insurance providers and how this affects therapy initiation and usage.

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Prescription of any mandibular advancement device
  • •Age ≥ 18 years
  • •Ability to understand the study information and information on usage of personal data
  • •Signed and dated informed consent

排除标准

  • •Patients with central sleep apnea (central AI > 5/hour)
  • •Patients with loose teeth and severe parodontitis
  • •Patients with completely missing teeth or removable tooth replacement, or with a teeth health insufficient to retain an MAD Patients with missing molars Patients with maximum protrusion of less than 5mm

结局指标

主要结局

Changes of the Apnoea-Hypopnea-Index (AHI) at baseline compared to a follow-up after 3 months

时间窗: 3 months

Changes in the number of apnoeas (cessation of airflow) and hypopneas (reduced airflow) at baseline and at follow-up

次要结局

  • Side effects with use of the MAD (mandibular advancement device)(3 months)
  • Document comorbidities of enrolled patients(3 months)
  • Changes in sleep-related quality of life from baseline compared to 3 months follow-up(3 months)
  • Changes in daytime sleepiness from baseline compared to 3 months follow-up(3 months)
  • Satisfaction with therapy(3 months)
  • Document sleep disorders of enrolled patients(3 months)
  • Changes in snoring from baseline compared to 3 months follow-up(3 months)
  • Usage of the MAD (mandibular advancement device)(3 months)
  • Remuneration of a MAD(3 months)
  • Continuation of therapy(3 months)

研究者

发起方
ResMed
申办方类型
Industry
责任方
Sponsor

研究点 (4)

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