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Completed

NCT Number: NCT03133442

Effect of Vestibular Stimulation on Sleep in Elderly

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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Key information

Conditions

Sleep

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sensory Motor Systems Lab

Zurich, 8092, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Somnomat V4

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.

Primary outcomes

  1. Polysomnography

    Time frame: 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.

Secondary outcomes

  1. Memory performance

    Time frame: Recall moment in evening and morning (4 nights)

    Difference in declarative memory performance between the second of two nights with intervention and the second of two nights without intervention. During each experimental night a word-pair recall task will be performed 1h before going to bed and half an hour after waking up. To assess declarative memory performance improvement, we will determine the difference between immediate and delayed recall. Word-pair recall tasks are suitable to determine declarative memory performance in the context of sleep, as they are sensitive to effects of sleep.

  2. Skin temperature

    Time frame: 4 nights of 7 hours each

    The distal-proximal temperature gradient will be calculated, based on skin temperature measured using sensors placed on the chest and hands, to look for a relationship with sleep onset latency.

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Collaborators

  • University of Zurich

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 28, 2017
Registry last updated
Aug 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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