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临床试验/NCT07497412
NCT07497412进行中(未招募)不适用

The Effect of Primary Airway Therapy on Blood Pressure in Excessively Sleepy Patients With Obstructive Sleep Apnoea: a Retrospective Analysis of the ANDANTE Data

King's College London1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2026年1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)
入组人数
10,000
试验地点
1
主要终点
Office blood pressure

研究概览

简要总结

Obstructive sleep apnoea (OSA) is one of the most common noncommunicable types of disease, it affects about 1 billion people across the world. Left untreated, it causes apnoeas and hypopnoeas to fragment sleep, with frequent arousal from sleep and intermittent hypoxia associated with increased work of breathing. Frequently, it leads to excessive daytime sleepiness, as measured subjectively by the Epworth Sleepiness Scale, or, objectively, by the multiple sleep latency test (MSLT) or the maintenance of wakefulness test (MWT). OSA can lead to sustained high sympathetic tone at night, which in the long-term may impact on the cardiovascular risk.

The investigators hypothesised that any primary airway therapeutic effect on the cardiovascular system, as measured by the blood pressure, in patients with OSA will differ dependent on whether subjects are excessively sleepy, or remain so when treated.

Hypothesis

  1. Office blood pressure (SBP, DBP) responses to CPAP in patients with OSA who are excessively sleepy (ESS>10) at baseline vs non-sleepy patients at baseline.
  2. 24-hour BP data (SBP, DBP, dipping, nocturnal and daytime) in sleepy patients in response to CPAP vs non-sleepy patients.
  3. Adherence to treatment in sleepy patients may be different to non-sleepy patients and the observed effect effects will be adjusted in a secondary analysis according to available adherence data and follow up time.

详细描述

Introduction

Obstructive sleep apnoea (OSA) is one of the most common noncommunicable types of disease, it affects about 1 billion people across the world. Left untreated, it causes apnoeas and hypopnoeas to fragment sleep, with frequent arousal from sleep and intermittent hypoxia associated with increased work of breathing. Frequently, it leads to excessive daytime sleepiness, as measured subjectively by the Epworth Sleepiness Scale, or, objectively, by the multiple sleep latency test (MSLT) or the maintenance of wakefulness test (MWT). OSA can lead to sustained high sympathetic tone at night, which in the long-term may impact on the cardiovascular risk.

With optimised primary airway treatment, normal breathing at night resumes and patients experience a restoration of normal sleep architecture, with little or no further sleep fragmentation due to the underlying sleep disordered breathing. Daytime symptoms and quality of life typically improve with primary airway treatment, and long-term cardiovascular risks follows.

Data from the ANDANTE collaboration have recently shown that the effect of primary airway patency treatment in patients with obstructive sleep apnoea on the blood pressure control differs according to whether patients with OSA have normal blood pressure, controlled or uncontrolled hypertension. Furthermore, the high prevalence of OSA in the general population, frequently diagnosed randomly (e.g., screening prior to elective surgery) in otherwise asymptomatic patients raises the question whether symptoms, like sleepiness, that are associated with the syndrome predict outcomes on the cardiovascular system.

There are clinically relevant implications in who should and who should not be treated with OSA, particularly in the cohort of mild/moderate and asymptomatic patients with OSA, as recently discussed in the Baveno, and the modified Baveno classification. Furthermore, a proportion of patients with OSA who are adherent to primary airway therapy remain symptomatic, as measured by the Epworth Sleepiness Scale, a phenomenon that has been labelled residual excessive daytime sleepiness. The cardiovascular risk associated with patients who are excessively sleepy at baseline, and who remain so, is unclear.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

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

  • Data for the individual patient data (IPD) meta-analysis, as published in the ANDANTE database (Pengo et al, European Respiratory Journal 2025)
  • Patient with OSA (apnoea hypopnea index, AHI > 5/hour)
  • age > 18 years
  • previous inclusion in published randomised controlled trial using primary airway therapy (intervention) or in the control arm

排除标准

  • Not included in a randomised controlled trial to treat OSA
  • not included in the ANDANTE database

结局指标

主要结局

Office blood pressure

时间窗: through study completion, an average of 3months

Office blood pressure measurements (systolic, diastolic in mmHg)

次要结局

  • 24 hours blood pressure(through study completion, an average of 3months)
  • Nocturnal blood pressure dipping pattern(through study completion, an average of 3months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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