Assessment of the Effect of PAP on Energy and Vitality in Mild OSA Patients: The Merge Study
Assessment of the Effect of Positive Airway Pressure on Energy and Vitality in Mild Obstructive Sleep Apnea Patients: The Merge Study
研究概览
详细说明
Patients who visit their local sleep service for OSA investigation, and are found to have mild OSA (AHI ≤ 15) from an Apnealink polygraphy (PG) home sleep test, scored as per AASM 2007 and/or AASM 2012, will be invited to take part in the study (pre-screening).
At the study visit, informed consent, baseline demographics, and standardised questionnaires will be administered. Participants will then be randomised to a CPAP treatment group or control group.
After 3 months, participants will be asked to repeat the standardised questionnaires, the trial will then be complete and they will return to routine clinical care.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Blackpool、英国
- Blackpool Teaching Hospital
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Cambridge、英国
- Papworth Hospital
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Dundee、英国
- Tayside Health Board, Ninewells Hospital
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Liverpool、英国
- Aintree University Hospital
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London、英国、SW3 6NP
- Royal Brompton Hospital, Imperial College London
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London、英国
- Guys & St Thomas Hospital
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Oxford、英国
- Oxford Centre for Respiratory Medicine
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Plymouth、英国
- Derriford Hospital
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Stevenage、英国
- Lister Hospital
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Taunton、英国
- Taunton and Somerset Hospital
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Newcastle
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Newcastle upon Tyne、Newcastle、英国
- Freeman Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Study Inclusion Criteria
- Aged ≥ 18 and ≤ 80
- Ability and willingness to provide written informed consent
- AHI ≤ 15 as per AASM 2007 scoring criteria
- Ability to tolerate a CPAP one hour long run in test
Exclusion Criteria:
- The presence of unstable cardiac disease
- Inability to give fully informed consent
- Supplemental oxygen
- Secondary sleep pathology e.g. Periodic Limb Movement Syndrome, Narcolepsy, Circadian Disorder, obesity hypoventilation syndrome
- ESS ≥ 15, or concerns about sleepy driving from physician/ sleep lab staff
- BMI ≥ 40
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：Continous Positive Airway Pressure
Participants in this group will use CPAP therapy, nightly, for the 3 month duration of the trial
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CPAP refers to the application of positive airway pressure through a mask and tubing to splint a patients throat open at night.
CPAP is considered standard treatment for OSA
其他名称：
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安慰剂比较：Control Group
Participants will receive standard care (Sleep hygiene counseling) during the study.
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Standard sleep hygiene counseling as per published guidelines
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Quality of Life Using the Energy and Vitality Subscale of the Short Form 36 (SF-36) Questionnaire
大体时间：3 months
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The Short Form 36 (SF-36) questionnaire measures quality of life through a range of questions asking about patients physical and mental functioning. Specifically, the Energy and Vitality subscale records patients perceptions of their levels of energy and fatigue. Participants were administered the Short Form 36 (SF-36) questionnaire at baseline and 3 months. The change in score (value at 3 months minus value at baseline) was compared between the CPAP group and the Control group. In the SF-36 Energy and Vitality subscale, an increase in score indicates improvement, with a minimum score of 0 and a maximum score of 100 possible. |
3 months
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合作者和调查者
赞助
调查人员
- 首席研究员：Mary Morrell, Prof、Imperial College London
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.