NCT05108363撤回不适用
Effect of Obstructive Sleep Apnea on Glucose Control and Cognitive Function - a Substudy of 'Continuous Glucose Monitoring as an Adjunct to Lifestyle Modification in Individuals With Impaired Glucose Tolerance: a Randomised Controlled Trial'
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change of Montreal Cognitive Assessment (MoCA) score
研究概览
简要总结
Obstructive sleep apnea (OSA) may contribute to altered cognitive function in patients suffering from severe OSA. And lifestyle modification program may improve the cognitive function after 6 months of therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI ≥ 25kg/m2
- •impaired glucose tolerance which defined as plasma glucose at the range of 7.8 and 11 mmol/l 2 hours after 75g oral glucose solution intake,
- •willing to participate in lifestyle modification program
- •and capable of using continuous glucose monitoring (CGM) as judged by investigator
排除标准
- •Lactating or pregnant,
- •known diabetes, current or previous use of glucose lowering drug
- •current participation in other weight loss or lifestyle interventions, or use of weight loss drugs,
- •current use of steroids
- •uncontrolled thyrotoxicosis
- •allergy to medical grade adhesives
- •known obstructive sleep apnea on continuous positive airway pressure therapy
- •symptoms of cognitive deterioration (according to the Hong Kong Montreal Cognitive Assessment (HK-MoCA) at the score of <21)
- •predominant central sleep apnea
- •uncontrolled hypertension (blood pressure >140/90mmHg) or requiring more than two anti-hypertensive medication
- •history of stroke or brain injury,
- •unstable cardiovascular disease (e.g. recent unstable angina or myocardial infarction within the previous 6 months or severe left ventricular failure; neuromuscular disease affecting or potentially affecting respiratory muscles; moderate to severe respiratory disease (i.e. breathlessness affecting activities of daily living) or documented hypoxemia or awake SaO2 <92%)
- •psychiatric disease that limits the ability to give informed consent or complete the study
- •Use of psychoactive medication.
研究组 & 干预措施
Lifestyle modification program
Other
Patients with obstructive sleep apnea and prediabetes will have lifestyle modification program for 12 months
干预措施: Lifestyle modification program (Behavioral)
结局指标
主要结局
Change of Montreal Cognitive Assessment (MoCA) score
时间窗: 12 months
Scores on the MoCA range from zero to 30, with a score of 26 and higher generally considered normal.
次要结局
- Change of apnea-hypopnea index(12 months)
研究者
Susanna SS Ng
Assistant Professor
Chinese University of Hong Kong
研究点 (1)
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