Clinical trial NCT03133442: Effect of Vestibular Stimulation on Sleep in Elderly
Official title: Effect of Vestibular Stimulation on Sleep in Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: University of Zurich
First posted: 2017-04-28
Enrollment: 19
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Polysomnography
timeFrame: 4 nights of 7 hours each
Secondary outcomes:
measure: Memory performance
timeFrame: Recall moment in evening and morning (4 nights)
measure: Skin temperature
timeFrame: 4 nights of 7 hours each
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Sensory Motor Systems Lab
Study officials:
affiliation: University of Zurich
name: Robert Riener, Prof.
role: PRINCIPAL_INVESTIGATOR
References: