The Gut-sleep-brain Axis: Targeting the Gut Microbiota and Sleep Quality by Individualized Non-pharmaceutical Approaches to Promote Healthy Ageing.
试验速览
- 阶段
- 不适用
- 入组人数
- 48
- 主要终点
- Mean percentage of Dreem device signal quality over a 14 day period
研究概览
简要总结
Our study aims to build on emerging evidence showing relationships between gut health, sleep and brain functions. To achieve this, our study aims to test the feasibility of using non-pharmacological interventions: a psychoeducation-based intervention (enhanced sleep education - ESE) and a dietary supplement (Saffron extract), to improve sleep in older adults with insomnia complaints. Our study also aims to test the feasibility of using wearable and commercially available EEG headband technology to measure objective sleep quality in the home, which will allow for a reliable and ecologically more valid sleep research.
详细描述
One-third of the UK adult population presents with disordered sleep, and the prevalence further increases with ageing. Disordered sleep has also been identified as a risk factor for dementia, which is alarming given that cases of dementia are predicted to triple across the world by 2050.
Our study aims to build on emerging evidence showing relationships between gut health, sleep, and brain functions. To achieve this, our study aims to test the feasibility of using non-pharmacological interventions: a psychoeducation-based intervention (enhanced sleep education - ESE) and a dietary supplement (Saffron extract), to improve sleep in older adults with insomnia. The study aims to test the feasibility of using wearable sleep tracking EEG technology (DREEM3 device) to measure sleep quality in the home environment, which could contribute to a reliable but naturalistic and accessible future sleep research.
The study is split into 4 phases:
Screening phase: Participants will be asked to complete an online screening assessment to check for eligibility.
Baseline assessment phase (1 week): Participants will complete in-person testing in the Sleep and Brain Research Unit (SBRU) located at the University of East Anglia, to assess their cognitive functions, psychological well-being, and postural control. They will be asked to provide a faecal sample to profile the baseline gut microbiota, a urine sample to gain a baseline measure for testing supplement adherence and wear the DREEM3 headband device and complete a sleep diary to track their sleep quality with a high accuracy in their habitual home environment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
Participant's and Investigators will be blinded to which participants are receiving the dietary saffron supplement and placebo. Random allocation will be conducted by an independent researcher.
Participants and investigators will not be blinded to which participants have been allocated ot the ESE intervention.
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged over 55 years
- •Conversational English and capacity to consent
- •Availability to take part in the study
- •Subjective sleep complaints of impaired sleep quality or insufficient sleep
- •Participants with no clinical diagnosis or signs of dementia (m-ACE-III score above 21)
- •Potential for sleep complications such as insomnia before the study
- •A body mass index between 20 and 35 for men, and 18.5 and 35 for women
- •High Score on Pittsburgh Sleep Quality Index (PSQI; > 5) OR The Insomnia Severity Index (ISI; > 10)
排除标准
- •Acute infections or diseases
- •Psychiatric disorders or chronic neurological conditions include a diagnosis of dementia, mild cognitive impairment (MCI)/ prodromal AD.
- •Learning, sensory, or motor impairment/ disabilities that would pose an unfair disadvantage in the cognitive tests
- •Chronic pain conditions
- •Currently taking blood thinning medications
- •Current diagnosis of malignant tumours/ cancers
- •Worked as a shift worker or travelled across more than three time zones in the past two months
- •Alcohol consumption above 14 units/week and/ use or dependency of illicit substances/alcohol
- •Consume more than 5 cups of caffeinated beverages (e.g., coffee/tea/coke, etc) per day.
- •Smokers (tobacco, e-cigarettes, or vapes)
- •Taking antibiotics, or any dietary supplements that may interfere with study outcomes.
- •Self-quarantined or presumed positive status for COVID-19 (see considerations for COVID-19 in safety and comfort section).
- •Currently enrolled or enrolled previously (within the last 2 months) in a drug trial.
- •Participants who show signs or symptoms of having dementia.
- •Participants with high scores (>10) on the Patient Heath Questionnaire-9 (PHQ-9) depression scale and/ or who indicate that they have suicidal thoughts
- •A diagnosis of untreated sleep apnoea or another sleep-related disorder excluding insomnia
结局指标
主要结局
Mean percentage of Dreem device signal quality over a 14 day period
时间窗: 2 weeks
Signal quality will range from 0-100%, with percentages \>80% indicating good signal quality. Higher signal quality will indicate higher levels of feasibility of the device as a method of measuring objective sleep quality based on electrical activity of the brain (electroencephalogram) within the home environment.
Changes in the time spent awake following initial sleep onset (in minutes) as measured by the Dreem electroencephalogram headband pre/post treatment conditions compared to a placebo.
时间窗: 4 weeks
Changes in the time spent awake following initial sleep onset (in minutes) will be used to measure objective sleep quality. Decreases in time spent awake following initial sleep onset (in minutes) will suggest feasibility of proposed treatment conditions for improving objective sleep quality.
Mean number of days on which participants ingested the dietary supplements (Saffr'Inside) per subject over a 4 week period
时间窗: 4 weeks
Frequency (mean number of days per subject) of ingestion of the dietary supplement will be used to measure the adherence rate of the supplement. Higher adherence rates will indicate higher levels of acceptability of using a supplement to improve sleep complaints.
Changes in scores on the self-reported sleep quality measure using the Pittsburgh Sleep Quality Index (PSQI) pre/post treatment conditions compared to a placebo.
时间窗: 4 weeks
Changes in scores on the Pittsburgh Sleep Quality Index (PSQI) pre/post treatment conditions compared to a placebo will be used to measure feasibility of using proposed treatment conditions to treat sleep difficulties. Treatment conditions include: Enhanced Sleep Education (ESE) intervention X Dietary Supplement (Saffr'Inside), ESE X Placebo, No ESE (control) X Dietary Supplement (Saffr'Inside), No ESE (control) X Placebo. A decrease in scores on the PSQI would indicate improved sleep and suggest feasibility of using the described treatment conditions to improve subjective sleep complaints. (Highest score = 21, Lowest score = 0)
Changes in scores on the Insomnia Severity Index (ISI) pre/post treatment conditions compared to a placebo.
时间窗: 4 weeks
Changes in Insomnia Severity Index (ISI) pre/post treatment conditions compared to a placebo will be used to measure feasibility of using proposed treatment conditions to treat sleep difficulties. Treatment conditions include: Enhanced Sleep Education (ESE) intervention X Dietary Supplement (Saffr'Inside), ESE X Placebo, No ESE (control) X Dietary Supplement (Saffr'Inside), No ESE (control) X Placebo. A decrease in scores on the ISI would indicate improved sleep and suggest feasibility of using the proposed treatment conditions to improve subjective sleep complaints. (Highest score = 28, Lowest score= 0)
Changes in objective sleep quality as measured by the sleep efficiency index based on the Dreem electroencephalogram headband pre/post treatment conditions compared to a placebo.
时间窗: 4 weeks
Sleep efficiency index will be measured using percentage (sleep efficiency = total sleep time / time in bed x 100). Changes in sleep efficiency index of sleep will be used to measure the feasibility of the proposed treatment conditions on improving objective sleep quality. Higher percentages of sleep efficiency suggest improved sleep.
Number of nights on which participants used the Dreem headband over a 14 day period
时间窗: 2 weeks
Frequency of Dreem headband usage over a 14 day period will be used to measure device adherence rates. Higher adherence rates will indicate higher levels of acceptability of the device as a method of measuring electrical activity (electroencephalogram) within the home environment
Number of Participants who report that they made changes to their sleeping habits following engagement in Enhanced Sleep Education (ESE).
时间窗: 4 weeks
Frequency of participants who make self-reported changed to their sleeping habits will be used to measure adherence rates to the Enhanced Sleep Education (ESE) intervention. Higher adherence to the intervention will indicate higher acceptability of this method for treating sleep complaints.
次要结局
- Changes in scores on the Patient Health Questionnaire (PHQ-9) pre/post treatment conditions compared to a placebo.(4 weeks)
- Changes in the time to complete (in seconds) on the Trail Making Task B pre/post treatment conditions compared to a placebo.(4 weeks)