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临床试验/NCT04340583
NCT04340583终止不适用

Subjective Sleep Quality and Prevalence of Sleep Disorders in Patients With Severe Asthma

Istituti Clinici Scientifici Maugeri SpA1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2019年9月10日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
16
试验地点
1
主要终点
subjective quality of sleep

研究概览

简要总结

Bronchial asthma is characterized by the presence of symptoms that vary over time and of severity. Asthma symptoms tend to worsen at night and in the early hours of the morning, and the presence of nocturnal symptoms is an important indicator of therapeutic intervention in order to control the severity of the disease. Aim of the study is to investigate sleep disorders and quality, as well as and depressive and anxiety symptoms in patients affected by severe asthma before and after 6 months of treatment with monoclonal therapy. An observational, cohort, prospective, monocentric study will be conducted to evaluate subjective quality of sleep at baseline and post monoclonal treatment.

详细描述

Rationale

Bronchial asthma is a heterogeneous and highly prevalent disease; moreover, it represents one of the main cost of the Italian National Health Care System. According to international guidelines, asthma is characterized by the presence of symptoms such as wheezing, dyspnoea, chest tightness and / or cough, and limitation of expiratory air flow, that vary over time and of severity.

The main therapy consists of the use of inhaled corticosteroids in order to reduce airway inflammation; however, in conditions characterized by frequent exacerbations, patients take oral corticosteroids (OCS) cyclically or chronically to control their symptoms. Asthma symptoms tend to worsen at night and in the early hours of the morning, and the presence of nocturnal symptoms is an important indicator of therapeutic intervention in order to control the severity of the disease.

Several studies have shown that nocturnal symptoms, such as cough and dyspnoea, are associated with circadian oscillations of airway inflammation and physiological variables, with consequent air flow limitation of and bronchial hyperreactivity. Moreover, it is known that patients receiving OCS are subjected to significant alterations of the hypothalamic-pituitary-adrenergic axis function, therefore the assumption of these drugs could cause a modification of the circadian rhythm.

Since sleep fragmentation that accompanies the worsening of nocturnal asthmatic symptoms is probably caused by the degree of severity of nocturnal bronchoconstriction, it is possible that severe asthmatic patients have greater bronchoconstriction and therefore more disturbed sleep.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of severe persistent asthma
  • Systemic steroids treatment for at least 6 months and/or ≥2 exacerbations in the last year
  • Need to initiate monoclonal antibody therapy according to guidelines
  • Age ≥18 years
  • Signed Informed consent
  • Patients able to collaborate in the required procedures

排除标准

  • Diagnosis of cognitive impairment

结局指标

主要结局

subjective quality of sleep

时间窗: 6 months

Pittsburgh Sleep Quality Index score ranging from 0 to 21, where lower scores denote a healthier sleep quality.

次要结局

  • circadian rhythm disorders(6 months)
  • Insomnia(6 months)
  • respiratory disorders(6 months)
  • diurnal sleepiness(6 months)
  • anxiety(6 months)
  • depression(6 months)
  • sleep quality(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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