Vestibular Stimulation, Exercise and Light Optimization for Circadian Clock Enhancement (Velocce)
NCT ID: NCT05030389
Last Updated: 2021-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2021-01-25
2023-01-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Adapted Physical Activity (APA)
Participants receive a web-based adapted physical activity (APA) during 12 weeks, on the basis of three at-home sessions a week
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.
Adapted Physical Activity + Bright Light Exposure (APA + BLE)
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
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.
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.
Galvanic Vestibular Stimulation (GVS)
Participants receive Galvanic Vestibular Stimulation (GVS) during two weeks, on the basis of five at-home sessions a week
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.
Health Education program (HE)
Participants receive a web-based health education program (HE) during 14 weeks, on the basis of one at-home session a week
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.).
Interventions
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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.
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.
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.
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.).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
60 Years
70 Years
ALL
Yes
Sponsors
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Région Normandie
OTHER_GOV
Université de Caen Normandie
OTHER
Responsible Party
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Principal Investigators
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Hervé Hervé, M.D. PhD.
Role: PRINCIPAL_INVESTIGATOR
Université de Caen Normandie, U1075 COMETE Inserm
Locations
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Antoine Langeard
Caen, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Université de Caen Normandie
Identifier Type: -
Identifier Source: org_study_id
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