Effect of Vestibular Stimulation on Sleep in Elderly
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Polysomnography
研究概览
简要总结
Vestibular stimulation might be beneficial for sleep. Previous research demonstrated that lateral rocking movements can facilitate the transition from wake to sleep during an afternoon nap. However, the relationship between rocking movements and sleep is poorly understood to date. Furthermore, studies looking at the effects of rocking on sleep have not yet been performed in an elderly population. Due to age related changes in sleep, people often experience a decrease in sleep efficiency and sleep quality later in life. Therefore, it is particularly this population that could benefit from a possible enhancement in sleep efficiency and sleep quality. In order to assess the effect of vestibular stimulation on sleep and sleep-dependant memory, measurements of two nights with stimulation will be compared to two baseline nights. The primary outcomes are changes in sleep onset, sleep architecture and power density spectra of the EEG due to vestibular stimulation. Secondary endpoints are sleep dependent changes in memory, the proximal-distal temperature gradient, cardiorespiratory variables and dream content.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Blinding of the participants is impossible, as the stimulation is easy to perceive and cannot be confused with a baseline night. Therefore, participants are informed about the character of the night (max. 5 minutes) before the moment of lights off. For safety reasons the experimenter that is present is also aware of the condition.
However, data is stored in a coded way, so that during data analysis the experimenter is not aware of the condition.
入排标准
- 年龄范围
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Right handed
- •Between 60 and 75 years of age
排除标准
- •Diseases or lesions of the nervous system (acute or residual included neurological and psychiatric diseases)
- •BMI < 19 or > 30 kg/m2
- •Medication known to influence sleep [56]
- •Cognitive Impairment (MoCA score < 26)
- •Drug use and abuse
- •Nicotine use (e.g. smoking)
- •> 10 alcoholic drinks per week
- •> 5 drinks or foods containing caffeine per day
- •History of sleep disorder (Insomnia, sleep apnea (apnea-hypopnea index >5), nocturnal myoclonus (>5 periodic leg movements per hour of sleep))
- •Irregular sleep-wake rhythm (e.g. shift working)
- •Travelling across time zones less than 1 month ago
- •Naps longer than 1h
- •Sleep on an average night <6 hours or >8 hours
- •Skin allergies or very sensitive skin
- •Diseases of the vestibular system
- •Signs of motion sickness based on questionnaire
研究组 & 干预措施
Baseline Nights
No vestibular stimulation is applied. However, the sound of the moving bed will be played back to the participant at the right sound intensity level.
Movement Nights
Vestibular stimulation, in the form of gentle rocking movements, is provided using the Somnomat V4 rocking bed. Stimulation is provided for the entire 7 hours of the night from lights off to lights on. The stimulation frequency is in the range of 0.1-0.3 Hz, with an amplitude in the range of 0.05 to 0.1m
干预措施: Somnomat V4 (Device)
结局指标
主要结局
Polysomnography
时间窗: 4 nights of 7 hours each
Difference in sleep parameters between the second of two nights with intervention and the second of two nights without intervention, as recorded using polysomnography. The sleep stages will be scored visually on a 20-s epoch basis according to standard criteria \[53\]. This will allow us to compare sleep architecture of the participants in the two conditions, as well as a possible consecutive nights effect in the two movement nights. Parameters of specific interest are sleep onset latency, total sleep time, time spent in N1, N2 and N3 stages of NREM sleep and time spent in REM sleep. Furthermore, the EEG power density spectra will be analysed. Power in specific frequency bands will be calculated based on spectral analysis, the amount and density of sleep spindles and slow waves will be determined.
次要结局
- Memory performance(Recall moment in evening and morning (4 nights))
- Skin temperature(4 nights of 7 hours each)