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临床试验/NCT05393531
NCT05393531已完成4 期

Comparison of First Line Non-invasive Treatment Options in Patients Diagnosed with Obstructive Sleep Apnea

University Hospital, Antwerp2 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2021年11月9日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
136
试验地点
2
主要终点
Overall therapeutic effectiveness of MAD and CPAP

研究概览

简要总结

The main objective is to evaluate the overall effectiveness of MAD therapy as a first line treatment, including both efficacy in terms of reduction in OSA severity as well as objective compliance, in patients recently diagnosed with moderate to severe OSA, waiting for a new CPAP device.

Upon completion of MAD-therapy, patients will be put on CPAP, allowing for comparison of MAD effectiveness versus the overall therapeutic effectiveness of CPAP therapy in the same patient.

Finally, patients' preference for either therapy will be evaluated.

详细描述

Obstructive sleep apnea (OSA) is a highly prevalent disorder, affecting up to 17% of middle-aged men. OSA is characterized by repetitive narrowing (hypopnea) or complete collapse (apnea) of the upper airway during sleep. This can cause intermittent breathing cessation during sleep, which leads to oxygen desaturation and micro-arousals during the night and eventually sleep fragmentation. Due to these perturbations, OSA is linked to a range of harmful sequelae: excessive daytime sleepiness, fatigue, an impaired cognitive performance, a reduced quality of life, an increased risk of occupational and traffic accidents, metabolic disturbances, hypertension, cardio- and cerebrovascular morbidity and OSA-related mortality. OSA severity is characterized by the apnea-hypopnea index (AHI), representing the amount of apneas and hypopneas during at least ten seconds, per hour of sleep. When studying OSA, one can also use the obstructive apnea-hypopnea index (OAHI) leaving out any central apnea component.

Due to the high prevalence as well as the individual and socioeconomic healthcare issues related to OSA, effective management of this chronic disorder is imperative. Continuous positive airway pressure (CPAP) is typically recommended as first line therapy for moderate to severe OSA, applying pressurized air throughout the respiratory cycle to keep the upper airway patent. Although CPAP is highly efficacious in reducing the severity of OSA, the clinical effectiveness is often compromised by a low patient acceptance and suboptimal adherence.

The alternative non-invasive treatment option is the use of a mandibular advancement device (MAD): this type of oral appliance protrudes the mandible during sleep, thereby enlarging and stabilizing the upper airway. The efficacy of MAD therapy in terms of reduction in AHI is demonstrated in clinical trials but turns out to be less efficacious compared to that obtained with CPAP. However, this suboptimal efficacy is counterbalanced by a higher compliance rate and relatively low discontinuation rate.

Nevertheless, studies comparing MAD with CPAP therapy outcomes show that both therapies are equally effective in reducing blood pressure and in reducing cardiovascular death. This might be explained by the greater efficacy of CPAP being offset by inferior compliance relative to MAD, resulting in similar clinical effectiveness. However, such studies are generally lacking objective compliance measurements for MAD therapy.

At this moment, different models of CPAP machines made by Philips Respironics were recalled in June 2021 due to a potential health risk: the polyester-based polyurethane sound abatement foam, which is used to reduce sound and vibration in these affected devices, may break down and potentially enter the device's air pathway. If this occurs, black debris from the foam or certain chemicals released into the device's air pathway may be inhaled or swallowed by the patient using the device. This indirectly implicates that there is a supply chain problem regarding new CPAP devices for patients recently diagnosed with moderate to severe OSA, and that those patients stay untreated until this supply chain problem is resolved. Up till now, this time frame is unclear.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Treatment
盲法
None

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

入选标准

  • oAHI ≥ 15 events/hour of sleep and < 65 events/hour of sleep
  • BMI < 35 kg/m²
  • waiting list to receive CPAP therapy but underwent the CPAP titration night

排除标准

  • dental status not good enough for MAD therapy

结局指标

主要结局

Overall therapeutic effectiveness of MAD and CPAP

时间窗: 3 months after start of the therapy (either MAD or CPAP)

Combination of adherence (hours use per night) and efficacy (decrease in apnea/hypopnea index measured during a polysomnography)

次要结局

  • Treatment preference by questionnarie: which treatment do you prefer: CPAP, MAD or none?(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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