Effects of Long-term Remote Health Monitoring Through Bright Light Exposure, Physical Adapted Activity and Galvanic Vestibular Stimulation on the Sleep of the Elderly: Study Protocol for a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in time in bed measured by actigraphy
研究概览
简要总结
This study investigates the effects of remote interventions based on the exposure to one or more zeitgebers (i.e. adapted physical activity alone or combined with bright light exposure, or galvanic vestibular stimulation) performed several times a week during three months on older adults' sleep and quality of life.
详细描述
More precisely, the main objective is to investigate the effects of interventions on objective sleep measures of older adults with a sleep complaint.
The main hypothesis is that the quantity and quality of sleep will be improved after the interventions in comparison to the active control group.
The second objective is to study the effects of these interventions on quality of life, physical condition, anxiety, depression and cognition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteer (men or women)
- •Aged from 60 to 70 years
- •Retired for at least 12 months
- •Having a sleep complaint (overall score on the Pittsburgh Sleep Quality Index (PSQI) > 5, enquire information when these complaints appeared)
- •Able to receive enlightened information in French and express consent
- •Having a circadian typology of the "intermediate", "moderate morning" or "moderate evening" type, according to the circadian typology questionnaire of Horne and Ostberg (1976)
- •Having cognitive abilities to understand oral instructions, objective by a Mini Mental State Examination (MMSE) score greater than or equal to 24
- •Having a personal computer with a web cam, a microphone and an internet connection
- •Living in Normandy
- •Affiliated to the social security system
- •French-speaking
排除标准
- •Illiteracy
- •Age-related macular degenerescence (AMD), blindness, visual acuity < 2 and other pathologies reducing the perception of light
- •Bradycardia treatments (beta-blockers, digitalis, antiarrhythmics, bradycardic calcium channel blockers, etc.)
- •Declaration of dementia (Alzheimer's disease, vascular dementia)
- •Declaration of vestibular or neurological anomalies
- •Declaration of progressive neurological disease (brain tumour, epilepsy, migraine, stroke, sclerosis, myoclonus, chorea, neuropathy, muscular dystrophies, myotonic dystrophy, Parkinson's disease)
- •Declaration of pathologies with short-term vital prognosis (cancer)
- •Unbalanced cardiovascular pathologies (uncontrolled high blood pressure, coronary artery disease, heart failure, cardiac arrhythmia due to atrial fibrillation)
- •Endocrine pathology (hypothyroidism, hyperthyroidism, type 1 diabetes)
- •Breathing failure
- •Recent hospitalisation (< 30 days)
- •Declaration of unstable psychiatric condition (psychosis, depression, bipolar, disorder)
- •Chronic medication that may interfere with memory measures or that may alter the quantitative and qualitative parameters of sleep (antidepressants, neuroleptic, antiparkinsonian drugs, corticosteroids, antiepileptics, central analgesics and muscle relaxants)
- •Presenting drug and/or alcohol addiction, coffee abuse
- •Having an extreme Chronotype (score on Horne and Ostberg Circadian Typology Questionnaire ≤ 30 or ≥ 70)
- •Having a moderate or high level of physical activity (categorial score in the International Physical Activity Questionnaire (IPAQ) short version)
结局指标
主要结局
Change in time in bed measured by actigraphy
时间窗: Actigraphy is recorded continuously during one week before the intervention (baseline) and one week after the intervention (at 12 and / or 14 weeks after baseline, depending on the intervention).
Objective measure of sleep quantity, expressed in minutes and based on bedtime and wake time.
Change in sleep onset latency measured by polysomnography
时间窗: Polysomnography is recorded one night before the intervention (baseline) and one night after the intervention (from 12 to 14 weeks after baseline, depending on the intervention).
Objective measure of sleep quantity expressed in minutes.
Change in sleep efficiency measured by polysomnography
时间窗: Polysomnography is recorded one night before the intervention (baseline) and one night after the intervention (from 12 to 14 weeks after baseline, depending on the intervention).
Objective measure of sleep quantity expressed in % and defined as 100 \* total sleep time / time in bed.
Change in percentage of time spent in the different stages sleep measured by polysomnography
时间窗: Polysomnography is recorded one night before the intervention (baseline) and one night after the intervention (from 12 to 14 weeks after baseline, depending on the intervention).
Objective measure of sleep quantity expressed in % of time spent in stage 1 sleep, stage 2 sleep, stage 3 sleep and in rapid eye movement (REM) sleep.
Change in wake time after sleep onset measured by actigraphy
时间窗: Actigraphy is recorded continuously during one week before the intervention (baseline) and one week after the intervention (at 12 and / or 14 weeks after baseline, depending on the intervention).
Objective measure of sleep quantity expressed in minutes.
Change in total sleep time measured by polysomnography
时间窗: Polysomnography is recorded one night before the intervention (baseline) and one night after the intervention (from 12 to 14 weeks after baseline, depending on the intervention).
Objective measure of sleep quantity expressed in minutes.
Change in wake time after sleep onset measured by polysomnography
时间窗: Polysomnography is recorded one night before the intervention (baseline) and one night after the intervention (from 12 to 14 weeks after baseline, depending on the intervention).
Objective measure of sleep quantity expressed in minutes.
Change in number of awakenings measured by polysomnography
时间窗: Polysomnography is recorded one night before the intervention (baseline) and one night after the intervention (from 12 to 14 weeks after baseline, depending on the intervention).
Objective measure of sleep quantity.
Change in sleep quality measured by polysomnography
时间窗: Polysomnography is recorded one night before the intervention (baseline) and one night after the intervention (from 12 to 14 weeks after baseline, depending on the intervention).
Objective measure of sleep quality. The variable use to determine sleep quality is the sleep fragmentation index (SFI). SFI is defined as the total number of awakenings and any sleep stage shift divided by the total sleep time ; and expressed in number of events per hour.
Change in sleep onset latency measured by actigraphy
时间窗: Actigraphy is recorded continuously during one week before the intervention (baseline) and one week after the intervention (at 12 and / or 14 weeks after baseline, depending on the intervention).
Objective measure of sleep quantity expressed in minutes.
Change in sleep quality measured by actigraphy
时间窗: Actigraphy is recorded continuously during one week before the intervention (baseline) and one week after the intervention (at 12 and / or 14 weeks after baseline, depending on the intervention).
Objective measure of sleep quality. Actigraphic measure of sleep quality is the fragmentation index defined as the sum of the Mobile time (%) and the Immobile bouts \<=1min (%).
Change in total sleep time measured by actigraphy
时间窗: Actigraphy is recorded continuously during one week before the intervention (baseline) and one week after the intervention (at 12 and / or 14 weeks after baseline, depending on the intervention).
Objective measure of sleep quantity expressed in minutes.
Change in sleep efficiency measured by actigraphy
时间窗: Actigraphy is recorded continuously during one week before the intervention (baseline) and one week after the intervention (at 12 and / or 14 weeks after baseline, depending on the intervention).
Objective measure of sleep quantity expressed in % and defined as 100 \* total sleep time / time in bed.
次要结局
- Change in quality of life(Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention))
- Change in state anxiety(Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention))
- Change in visual analog scale of anxiety(Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention))
- Change in the Geriatric Depression Scale(Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention))
- Change in cognitive functions: trail making test (TMT)(Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention))
- Change in Hand grip strength(Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention))
- Change in Postural balance(Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention))
- Change in cognitive functions: dual-task Baddeley(Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention))
- Change in Leg extension power(Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention))
- Change in the Global Physical Activity Questionnaire (GPAQ)(Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention))
- Change in Timed up and go test(Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention))
- Change in cognitive functions: Stroop test(Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention))
- Change in long term memory(Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention))
- Change in maximum incremental cardiopulmonary test(Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention))