The Prevalence and Treatment of Sleep Disorders in Lung Transplant Recipients With BOS 2 & 3 and the Influence on Quality of Life and Daytime Activity.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- To Measure Prevalence of sleep disorders in Bronchiolitis Obliterans 2&3 patients
研究概览
简要总结
This study is to determine whether sleep disorders contribute to impaired quality of life and mobility in patients with Bronchiolitis Obliterans syndrome and whether non invasive positive airways pressure ventilation can improve sleep, quality of life and mobility in this patient group.
详细描述
Patients with Bronchiolitis Obliterans syndrome (BOS) 2 & 3 (25) will be matched 1:2 BOS 0 patients with similar demographics such as age, gender, BMI, time post transplant and renal dysfunction.Patients fitting inclusion/exclusion criteria once they have given informed consent will complete questionnaires on quality of life (QOL), any sleep issues they may have and be assessed by a doctor. Data from standard blood tests, respiratory function tests and physio assessments of daytime activity, mobility and muscle strength will be collected. All participants will undergo an overnight sleep study. If a sleep disorder is identified the participant will be offered appropriate treatment. All assessments with the exception of the sleep study will be repeated at 6 and 12 months post sleep study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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
- •Patients who are post lung, heart lung and heart lung liver transplant with bronchiolitis obliterans 2 & 3
- •Comparative group -Patients who are post lung, heart lung and heart lung liver transplant with bronchiolitis obliterans 0
- •Identified possible sleep related disorder
排除标准
- •Subjects who do not provide informed consent
- •Subjects unable to understand the study and related procedures
- •Patients with a life expectancy of less than 6 months
结局指标
主要结局
To Measure Prevalence of sleep disorders in Bronchiolitis Obliterans 2&3 patients
时间窗: 12 months
Using level one laboratory based polysomnograph
次要结局
- Quality of life assessment using Rand SF36 standard survey(Baseline, 6 and 12 months after sleep study)
研究者
Anne Carle
Dr A. Fiene & Dr J Douglas
The Prince Charles Hospital