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

Université de Caen Normandie

Status: Unknown

Conditions: Healthy Aging

Treatments: Behavioral: Adapted Physical Activity (APA); Behavioral: Galvanic Vestibular Stimulation (GVS); Behavioral: Health Education program (HE); Behavioral: Bright Light Exposure (BLE)

Study type: Interventional

Funder types: Other

Identifiers

NCT05030389

Université de Caen Normandie

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 60 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteer (men or women)
• Aged from 60 to 70 years
• Retired for at least 12 months
• Having a sleep complaint (overall score on the Pittsburgh Sleep Quality Index (PSQI) > 5, enquire information when these complaints appeared)
• Able to receive enlightened information in French and express consent
• Having a circadian typology of the "intermediate", "moderate morning" or "moderate evening" type, according to the circadian typology questionnaire of Horne and Ostberg (1976)
• Having cognitive abilities to understand oral instructions, objective by a Mini Mental State Examination (MMSE) score greater than or equal to 24
• Having a personal computer with a web cam, a microphone and an internet connection
• Living in Normandy
• Affiliated to the social security system
• French-speaking

Exclusion criteria

• Illiteracy
• Age-related macular degenerescence (AMD), blindness, visual acuity < 2 and other pathologies reducing the perception of light
• Bradycardia treatments (beta-blockers, digitalis, antiarrhythmics, bradycardic calcium channel blockers, etc.)
• Declaration of dementia (Alzheimer's disease, vascular dementia)
• Declaration of vestibular or neurological anomalies
• Declaration of progressive neurological disease (brain tumour, epilepsy, migraine, stroke, sclerosis, myoclonus, chorea, neuropathy, muscular dystrophies, myotonic dystrophy, Parkinson's disease)
• Declaration of pathologies with short-term vital prognosis (cancer)
• Unbalanced cardiovascular pathologies (uncontrolled high blood pressure, coronary artery disease, heart failure, cardiac arrhythmia due to atrial fibrillation)
• Endocrine pathology (hypothyroidism, hyperthyroidism, type 1 diabetes)
• Breathing failure
• Recent hospitalisation (< 30 days)
• Declaration of unstable psychiatric condition (psychosis, depression, bipolar, disorder)
• Chronic medication that may interfere with memory measures or that may alter the quantitative and qualitative parameters of sleep (antidepressants, neuroleptic, antiparkinsonian drugs, corticosteroids, antiepileptics, central analgesics and muscle relaxants)
• Presenting drug and/or alcohol addiction, coffee abuse
• Having an extreme Chronotype (score on Horne and Ostberg Circadian Typology Questionnaire ≤ 30 or ≥ 70)
• Having a moderate or high level of physical activity (categorial score in the International Physical Activity Questionnaire (IPAQ) short version)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 4 patient groups

Adapted Physical Activity (APA)

Experimental group

Description:

Participants receive a web-based adapted physical activity (APA) during 12 weeks, on the basis of three at-home sessions a week

Treatment:

Behavioral: Adapted Physical Activity (APA)

Adapted Physical Activity + Bright Light Exposure (APA + BLE)

Experimental group

Description:

Participants receive a web-based APA program during 12 weeks on the basis of three at-home sessions a week, supplemented by a bright light exposure (BLE) during 12 weeks, on the basis of five at-home sessions a week

Treatment:

Behavioral: Bright Light Exposure (BLE)

Behavioral: Adapted Physical Activity (APA)

Galvanic Vestibular Stimulation (GVS)

Experimental group

Description:

Participants receive Galvanic Vestibular Stimulation (GVS) during two weeks, on the basis of five at-home sessions a week

Treatment:

Behavioral: Galvanic Vestibular Stimulation (GVS)

Health Education program (HE)

Active Comparator group

Description:

Participants receive a web-based health education program (HE) during 14 weeks, on the basis of one at-home session a week

Treatment:

Behavioral: Health Education program (HE)