Evaluation of the Comfort of a Continuous Positive Airway Pressure Nasal Mask in the Treatment of Obstructive Sleep Apnea Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To evaluate the comfort and general appreciation of a nasal mask
研究概览
简要总结
Continuous positive airway pressure (CPAP) is the first-line treatment for obstructive sleep apnea syndrome (OSA). It consists of a pressure generator connected to a mask applied to the patient's face. CPAP treatment is restrictive, and nearly a quarter of patients abandon it over the long term. Various factors can influence adherence to CPAP therapy, including adverse events associated with the mask. However, it is clear that compliance with CPAP treatment, even if it has tended to improve over the last 30 years, is still sub-optimal.
The "Air Liquide Medical Systems" company has developed a mask that aims to improve comfort and ease of use for the patient. This leaky nasal mask has a "silent" intentional leak port, which significantly reduces the noise caused by the escape of air. The noise associated with intentional leakage is one of the discomforts reported by patients and their spouses. In addition, this mask is equipped with a new generation headgear with adjustment indicators to assist the patient in fitting the mask. Optimal headgear fit is a prerequisite for comfort during treatment, as it reduces unintentional leakage.
The main objective is to evaluate, through a questionnaire, the comfort and general appreciation of a nasal mask equipped with a silent leak system and a headgear with adjustment aids, of patients with OSA treated with CPAP.
Secondary objectives are :
- To evaluate the appearance of CPAP side effects related to the mask,
- To collect the patient's appreciation of the mask headgear,
- To evaluate the discomfort caused by the nasal obstruction reported by the patient,
- To evaluate the daytime sleepiness of the patient,
- To study the parameters of the CPAP treatment.
详细描述
Continuous positive airway pressure (CPAP) is the first-line treatment for obstructive sleep apnea syndrome (OSA). It consists of a pressure generator connected to a mask applied to the patient's face. CPAP treatment is restrictive, and nearly a quarter of patients abandon it over the long term. Various factors can influence adherence to CPAP therapy, including adverse events associated with the mask. Unintentional leaks, i.e. a leak between the pressure generator and the patient's upper airway, are among the most frequent. Therefore, optimizing the choice of mask is one of the main means used by medical-technical providers, in charge of installing CPAP and its technical follow-up at home. In order to cover the needs and anatomical particularities of the OSA patient population treated with CPAP, a large number of mask types and sizes are currently available on the market. However, it is clear that compliance with CPAP treatment, even if it has tended to improve over the last 30 years, is still sub-optimal.
The "Air Liquide Medical Systems" company has developed a mask that aims to improve comfort and ease of use for the patient. This leaky nasal mask has a "silent" intentional leak port, which significantly reduces the noise caused by the escape of air. The noise associated with intentional leakage is one of the discomforts reported by patients and their spouses. In addition, this mask is equipped with a new generation headgear with adjustment indicators to assist the patient in fitting the mask. Optimal headgear fit is a prerequisite for comfort during treatment, as it reduces unintentional leakage.
The main objective is to evaluate, through a questionnaire, the comfort and general appreciation of a nasal mask equipped with a silent leak system and a headgear with adjustment aids, of patients with OSA treated with CPAP.
After 30 days of use, secondary objectives are :
- To evaluate the appearance of CPAP side effects related to the mask (air leaks, injury to the nasal bridge, etc.)
- To collect the patient's appreciation of the mask headgear, which includes indications to help with the installation in the form of graduated markers, as well as the appreciation of the general aesthetics of the mask.
- To evaluate the discomfort caused by the nasal obstruction reported by the patient, in relation to the inclusion.
- To evaluate the daytime sleepiness of the patient, compared to the inclusion.
- To study the parameters of the CPAP treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 否
入选标准
- •Male or female patient over 18 years of age
- •Patient with OSA
- •Patient not previously treated with CPAP
- •A patient who will be treated with a "ResMed Airsense 10" CPAP and an "Air Liquide Medical Systems" NINA mask
- •Patient whose CPAP treatment will be installed and monitored by the home care provider AGIRADOM
- •Patient willing to participate in the research after adequate information and delivery of the information note
- •Patient affiliated to the social security system or beneficiary of such a system
排除标准
- •NOSE questionnaire score greater than or equal to 10/20 at the time of CPAP installation
- •Patient with significant craniofacial deformities that do not allow the mask to be fitted correctly
- •Person deprived of liberty by judicial or administrative decision, person under legal protection (patient under guardianship or curators) Article L1121-8
- •Subject who receives more than 4500 euros in compensation for his or her participation in other research involving the human person in the 12 months preceding this study
结局指标
主要结局
To evaluate the comfort and general appreciation of a nasal mask
时间窗: After 30 days of CPAP treatment
to evaluate, through a questionnaire, the comfort and general appreciation of a nasal mask equipped with a silent leak system and a headgear with adjustment aids, of patients with OSA treated with CPAP.
次要结局
- To evaluate the appearance of CPAP side effects related to the mask(After 30 days of CPAP treatment)
- To collect the patient's appreciation of the mask headgear(After 30 days of CPAP treatment)
- To evaluate the discomfort caused by the nasal obstruction reported by the patient(After 30 days of CPAP treatment)
- To evaluate the daytime sleepiness of the patient(After 30 days of CPAP treatment)
- To collect the CPAP treatment compliance(During the 30 days of CPAP treatment)
- To collect the unintentional leakage(During the 30 days of CPAP treatment)
- To collect the CPAP therapeutic pressures(During the 30 days of CPAP treatment)