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临床试验/NCT01985347
NCT01985347Unknown不适用

The SAD Study - SLEEP, ANXIETY & DEPRESSION Study A Prospective Cohort Study

The Queen Elizabeth Hospital2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2013年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
500
试验地点
2
主要终点
To establish the prevalence of anxiety and depression in patients with sleep disorders and compare how this prevalence differs from its prevalence in COPD and in the general population.

研究概览

简要总结

The prevalence of anxiety and depression in our OSA population is more than in COPD and the general population of North West Adelaide. (principal hypothesis).

CPAP therapy in OSA population produces a positive effect on the anxiety and depression scale.

The Investigators intend to study the prevalence of anxiety and depression in patients with sleep disorders in comparison to patients with COPD and subsequently, to assess whether CPAP has a role in controlling anxiety and depression in depressed and anxious patients with sleep apnoea.

This is a two phase study, in first phase; investigator will assess the prevalence of anxiety and depression, in a population with sleep disorders to check whether it is different to the prevalence in the COPD population. The prevalence of depression in Sleep Disorder population will also be compared with the Adelaide North Western general population, which was reported in The North West Adelaide Health Study. According to this epidemiological survey, which was conducted from 2008 to 2010, the prevalence of depression in Adelaide North Western general population was 20%.During the second phase of the study investigator will evaluate the effect of CPAP on anxiety and depression scores in the depressed and anxious patients with sleep apnoea by comparing the pre and post CPAP anxiety and depression status. The Hospital Anxiety and Depression (HAD) scale will be used to assess Anxiety and Depression, which is a well-documented tool for assessing symptoms of anxiety and depression in patients with somatic diseases.

详细描述

AIM (S) / OBJECTIVE OF STUDY

  1. To compare the prevalence of anxiety and depression in patients with sleep disorders (OSA), COPD and the general population of North West Adelaide.
  2. To study the effect of CPAP on depression and anxiety in patients with sleep apnoea who also have anxiety and depression.

STUDY DESIGN/ SETTING/LOCATION/POPULATION

This is a multicenter Prospective Cohort study run at the Lyell McEwin Hospital (LMH) and The Queen Elizabeth Hospital (TQEH), among patients attending the Respiratory and Sleep Outpatient Clinics at the Lyell McEwin Hospital (LMH) and The Queen Elizabeth Hospital (TQEH). These both sites are teaching tertiary hospital.

STUDY OUTCOMES

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients attending the Respiratory and Sleep Outpatient Clinics at LMH and TQEH with OSA or COPD
  • Aged over 18 years

排除标准

  • Unwilling or unable to give informed written consent

结局指标

主要结局

To establish the prevalence of anxiety and depression in patients with sleep disorders and compare how this prevalence differs from its prevalence in COPD and in the general population.

时间窗: 24weeks

次要结局

  • To evaluate whether treatment with CPAP improves anxiety and depression symptoms (HAD scale) at 3 and 12 months in OSA patients with anxiety and depression.(24 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Faisal Ameer

Dr

The Queen Elizabeth Hospital

研究点 (2)

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