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临床试验/NCT02371057
NCT02371057已完成不适用

The Prevalence of Acromegaly in the Sleep Apnoea Clinic

The Leeds Teaching Hospitals NHS Trust1 个研究点 分布在 1 个国家目标入组 653 人开始时间: 2014年11月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
653
试验地点
1
主要终点
The prevalence of acromegaly within patients referred to the sleep apnoea clinic.

研究概览

简要总结

Estimates of the prevalence of acromegaly, a condition resulting from excess growth hormone secretion, are as high as 1:1000. If detected late acromegaly increases the risk of joint destruction, heart disease, sleep apnoea, high blood pressure, diabetes, and polyps in the colon. To have a greater effect on long-term outcomes this disease needs to be detected early. By screening a 'high risk' population (sleep apnoea clinic) the investigators may be able to detect these patients earlier and prevent late complications of the disease. At LTHT the referral pathway for new referrals to the sleep apnoea clinic involves initial attendance to pick up a pulse oximeter to wear overnight to measure oxygen levels. These readings show approximately 1:4 patients displays evidence of significant obstructive sleep apnoea to warrant referral to the treatment group for continuous positive airway pressure (CPAP), weight management, and occasionally mandibular adjustment.

Patients attending the sleep apnoea clinic either as new referral or for review will be asked to participate in the proposed study. The study is cross-sectional in design incorporating two sub-populations within the sleep apnoea clinic. The first cohort comprises patients under follow-up known to have sleep apnoea, and the second cohort those patients prospectively attending the sleep apnoea clinic for assessment. If after an explanation of the study they agree to participate blood will be taken for assessment of IGF-I and they will be asked to complete a simple questionnaire.

The aim will to be to screen 1000 consecutive patients. The questionnaire will incorporate five simple questions to be completed with a 'yes' or 'no' answer. Where IGF-I levels are elevated patients will be investigated further for the possibility of acromegaly. The presence of biochemically proven acromegaly will be used to determine if the simple question has sufficient sensitivity to use as a screening tool.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 16 and above.
  • Referred to the Sleep Apnoea Clinic for assessment of obstructive sleep apnoea
  • Have capacity to given informed consent.

排除标准

  • Patients under 16 years of age
  • Not referred to the Sleep Apnoea Clinic
  • Unable to give informed consent

结局指标

主要结局

The prevalence of acromegaly within patients referred to the sleep apnoea clinic.

时间窗: 2 years

次要结局

未报告次要终点

研究者

发起方
The Leeds Teaching Hospitals NHS Trust
申办方类型
Other
责任方
Sponsor

研究点 (1)

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