Effect of Vestibular Stimulation on Sleep in Elderly

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-12

Study Completion Date

2018-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Sleep

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

The study has a two-by-two cross-over design. Participants spend two consecutive baseline nights (without stimulation) and two consecutive movement nights (with stimulation) in the laboratory. The order of baseline and movement nights is randomized.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

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.

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

Somnomat V4

Intervention Type DEVICE

Vestibular stimulation is provided using an innervated bed platform. This robotic device consists of a standard single bed, mounted on a moving mechanism. It was developed and produced by the ETH Zürich and approved for use in this study by Swissmedic.

Interventions

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Somnomat V4

Vestibular stimulation is provided using an innervated bed platform. This robotic device consists of a standard single bed, mounted on a moving mechanism. It was developed and produced by the ETH Zürich and approved for use in this study by Swissmedic.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Right handed
* Between 60 and 75 years of age

Exclusion Criteria

* 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

Minimum Eligible Age

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes