Non-REm Sleep inTervention to improvE Diabetes RESTED
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Blood glucose (CGM)
研究概览
简要总结
Diabetes is a known risk factor for cardiovascular disease. This research aims to improve glucose metabolism in patients with T2DM thereby reducing the impact of diabetes and the subsequent risk of future cardiovascular events. The investigators propose that improved sleep health will result in improved glucose levels in participants with T2DM.
The investigators plan to use short bursts of sound (pink noise) during sleep to improve the deep-sleep phase. The study will be a 'crossover randomised controlled trial' in which two different treatments (intervention and control) are compared in all participants.
The study will be based at the University of Lincoln Sleep Laboratory. Participants will be recruited via local GP practices. Twenty five adults with T2DM who have normal sleeping patterns will be invited to attend the sleep laboratory on 3 nights, each visit separated by one week.
The primary outcome measure for this study will be the difference in mean glucose between the intervention and control periods over the first 24 hours after waking.
Participants will be fitted with sensors on their faces to measure muscle tone and eye-movements and scalps to measure brain activity (EEG) and earphones that will deliver the 'pink noise'. The first night will be a 'sham' visit with no intervention, and nights 2 and 3 will be randomised to either intervention or control. An oral glucose tolerance test will be performed on the mornings of visits 2 and 3. During visits 2 and 3 participants will be fitted with a continuous glucose monitor which will be worn for 7 days.
This is a feasibility study and the findings will be used to design a large randomised controlled trial. With the increasing prevalence of diabetes it is important to develop new approaches without the frequently observed side effects associated with pharmacological treatments to improve glucose control in patients with T2DM.
详细描述
The proposed project uses a 'crossover randomised controlled trial' design, where two different treatments are compared in all participants. Each participant will therefore receive both treatments (sound intervention, and no intervention) and the project will compare the impact of the two treatments on the same participant. This means each person acts as their own control.
The research will be conducted in the newly built Sleep Laboratory at the University of Lincoln, which is composed of two participant bedrooms and an observation room. Participants will have access to a toilet and shower.
Potential participants will be identified by their General Practitioner (GP) by searching the practice database and screening records for eligibility. All eligible potential participants will receive a study information pack sent from the GP practice. There will be contact details to allow anyone wishing to take part to make contact with the study team having read the study information pack.
The investigators will also recruit via university email and staff web page. Potential participants may then contact the research team to request a study information pack which will be emailed or posted as above.
Screening Potential participants will express an interest in the study by contacting one of the research team. They will be screened over the phone by checking inclusion and exclusion criteria. If eligible to take part they will be invited to a recruitment visit with at least 24 hours to read the participant information sheet and ask any questions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Able to give informed consent
- •Over 18 years of age
- •Diagnosed with T2DM, as defined by WHO
- •Managed by diet and metformin, for at least 3 months
- •Able to speak and understand English
- •A regular single-phase of sleep (ie. single period of sleep per 24 hours)
- •Normally wakes before 09:00 am and achieves at least 6 hours of sleep
排除标准
- •T2DM treated with any medication other than diet and metformin
- •Change in regular medication during the study period
- •Any other physical or psychological disease likely to interfere with the normal conduct of the study such as coeliac disease or untreated hypothyroidism
- •Clinically-diagnosed Obstructive Sleep Apnoea
- •Epworth Sleepiness Score above 10
- •Prior history of drug, alcohol or solvent abuse
- •Self-reported hearing loss or impairment
研究组 & 干预措施
experimental
Sleep Audiological Intervention Device (SleepAID)
干预措施: Sleep Audiological Intervention Device (SleepAID) (Other)
control
no sound
干预措施: sham control (Other)
结局指标
主要结局
Blood glucose (CGM)
时间窗: Over 24 hours
Continuous glucose monitoring (mmol/l)
次要结局
- Blood glucose (OGTT)(2 hours post bolus ingestion of glucose)