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Effect of Vestibular Stimulation on Sleep in Elderly

Effect of Vestibular Stimulation on Sleep in Elderly

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03133442
Enrollment
19
Registered
2017-04-28
Start date
2017-11-12
Completion date
2018-11-30
Last updated
2019-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep

Brief summary

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.

Interventions

DEVICESomnomat 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.

Sponsors

University of Zurich
CollaboratorOTHER
Swiss Federal Institute of Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
60 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Polysomnography4 nights of 7 hours eachDifference 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

MeasureTime frameDescription
Memory performanceRecall 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.
Skin temperature4 nights of 7 hours eachThe 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.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026