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Effect of Vestibular Stimulation on Sleep in Elderly

F

Federal Institute of Technology (ETH) Zurich

Status

Completed

Conditions

Sleep

Treatments

Device: Somnomat V4

Study type

Interventional

Funder types

Other

Identifiers

NCT03133442
SOMNOMAT V4

Details and patient eligibility

About

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.

Enrollment

19 patients

Sex

All

Ages

60 to 75 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

19 participants in 2 patient groups

Baseline Nights
No Intervention group
Description:
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
Experimental group
Description:
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
Treatment:
Device: Somnomat V4

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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