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临床试验/NCT07152990
NCT07152990尚未招募不适用

Prevalence of Nocturnal Hypoventilation Diagnosed by Transcutaneous Oxy-capnography in a Population of Obese Subjects Fitted With Continuous Positive Airway Pressure for Obstructive Sleep Apnea Hypopnea Syndrome.

University Hospital, Toulouse1 个研究点 分布在 1 个国家目标入组 139 人开始时间: 2025年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
139
试验地点
1
主要终点
Prevalence of nocturnal alveolar hypoventilation

研究概览

简要总结

CAPNOSOH study is a single-center study conducted at Toulouse University Hospital, aiming to estimate the prevalence of obese and apneic subjects maintaining nocturnal hypoventilation under continuous positive airway pressure (CPAP).

详细描述

Obstructive sleep apnea hypopnea syndrome (OSAS) is highly prevalent in the global population (1 in 10 people worldwide according to Inserm), particularly in relation to the increase in the prevalence of obesity. The standard treatment for this pathology is continuous positive airway pressure (CPAP) which most often allows, when properly applied and adjusted, the normalization of symptoms and the apnea-hypopnea index (AHI). In addition to OSAHS, some obese subjects are at risk of presenting hypoventilation obesity syndrome (OHS) defined by the presence of obesity (body mass index [BMI] > 30 kg/m2) associated with diurnal hypoventilation. (PaCO2 > 45 mmHg) in the absence of other respiratory pathology. Identifying patients with OS is often difficult but essential, as early as possible.

Transcutaneous capnography, when properly performed and interpreted, is a much more informative tool than nocturnal oximetry, and could therefore allow better screening for these patients. It is an examination increasingly used in pulmonology departments/sleep centers.

The CAPNOSOH study is a single-center study conducted at Toulouse University Hospital, aiming to estimate the prevalence of obese and apneic subjects maintaining nocturnal hypoventilation under continuous positive airway pressure (CPAP). The study hypothesis is based on the limited data present in the literature. This is preliminary work for a multicenter study aimed at determining the impact of nocturnal hypoventilation without daytime hypercapnia on the quality of life and morbidity and mortality of patients.

We estimate that between 10 to 20% of obese subjects on CPAP hypoventilate at night.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Obese patients (Body Mass Index > 30 kg/m2)
  • •Fitted by one of the following providers: ASTEN, Vitalaire, Orkyn, ISIS, RespiO2, BASTIDE for > 3 months with compliance of more than 4 consecutive hours per night in average during 3 months
  • •"Good quality" criteria for continuous positive airway pressure (CPAP) treatment: compliance > 4 consecutive hours per night, unintentional leaks < limit defined by the manufacturer, residual AHI < 10/h
  • •Aged 18 to 80
  • •Affiliated or beneficiaries of the social security system or equivalent
  • •Having given written informed consent
  • •Able to understand instructions and information given

排除标准

  • •Patient under legal protection measure
  • •Non-compliant patients
  • •Pregnant or breast-feeding women (assessed on questioning)

研究组 & 干预措施

Obese Patients with Obstructive Sleep Apnea/Hypopnea

Other

干预措施: Quality of life questionnaires (Other)

Obese Patients with Obstructive Sleep Apnea/Hypopnea

Other

干预措施: Transcutaneous Oxy-Capnography (Other)

Obese Patients with Obstructive Sleep Apnea/Hypopnea

Other

干预措施: Arterial gasometry (Other)

Obese Patients with Obstructive Sleep Apnea/Hypopnea

Other

干预措施: Body plethysmography (Other)

Obese Patients with Obstructive Sleep Apnea/Hypopnea

Other

干预措施: Spirometry with reversibility test (Other)

Obese Patients with Obstructive Sleep Apnea/Hypopnea

Other

干预措施: Clinical examination (Other)

结局指标

主要结局

Prevalence of nocturnal alveolar hypoventilation

时间窗: 1 month

Prevalence of nocturnal alveolar hypoventilation will be diagnosed by transcutaneous oxy-capnography. Nocturnal alveolar hypoventilation is defined with PTcCO2 \> 49 mmHg more than 10% of the time of capnographic recording.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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