NCT05030389

Vestibular Stimulation, Exercise and Light Optimization for Circadian Clock Enhancement (Velocce)

Effects of Long-term Remote Health Monitoring Through Bright Light Exposure, Physical Adapted Activity and Galvanic Vestibular Stimulation on the Sleep of the Elderly: Study Protocol for a Randomised Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Université de Caen Normandie · Academic / Other
• Sex: All
• Age: 60 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This study investigates the effects of remote interventions based on the exposure to one or more zeitgebers (i.e. adapted physical activity alone or combined with bright light exposure, or galvanic vestibular stimulation) performed several times a week during three months on older adults' sleep and quality of life.

Detailed description

More precisely, the main objective is to investigate the effects of interventions on objective sleep measures of older adults with a sleep complaint. The main hypothesis is that the quantity and quality of sleep will be improved after the interventions in comparison to the active control group. The second objective is to study the effects of these interventions on quality of life, physical condition, anxiety, depression and cognition.

Conditions

• Healthy Aging

Interventions

Type	Name	Description
BEHAVIORAL	Adapted Physical Activity (APA)	The APA program lasts 12 weeks and consists in three one-hour at-home sessions a week (total of 36 sessions), including two aerobic dominant web-based sessions and one muscle strengthening self-guided session.
BEHAVIORAL	Bright Light Exposure (BLE)	Bright light exposure (BLE) consists in using lamps for light therapy during 12 weeks, at the rate of five one-hour at-home sessions a week.
BEHAVIORAL	Galvanic Vestibular Stimulation (GVS)	The GVS program lasts 2 weeks and consists in five 20-minutes at-home sessions a week (total of 10 sessions), using a portable galvanic stimulator.
BEHAVIORAL	Health Education program (HE)	The HE program lasts 14 weeks and consists in one one-hour at-home session a week (total of 14 sessions). This web-based intervention includes courses on general health (sleep habits, diet, physical activity, cardiovascular diseases, etc.).

Timeline

• Start date: 2021-01-25
• Primary completion: 2022-06-01
• Completion: 2023-01-01
• First posted: 2021-09-01
• Last updated: 2021-09-01

Locations

1 site across 1 country: France