Clinical trial NCT05030389: Vestibular Stimulation, Exercise and Light Optimization for Circadian Clock Enhancement (Velocce)
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Aging
Keywords: Exercise
Biological rhythms
Vestibular stimulation
Lead sponsor: Université de Caen Normandie
Sponsor class: OTHER
Collaborators: name: Région Normandie
First posted: 2021-09-01
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in sleep onset latency measured by polysomnography
timeFrame: Polysomnography is recorded one night before the intervention (baseline) and one night after the intervention (from 12 to 14 weeks after baseline, depending on the intervention).
measure: Change in total sleep time measured by polysomnography
timeFrame: Polysomnography is recorded one night before the intervention (baseline) and one night after the intervention (from 12 to 14 weeks after baseline, depending on the intervention).
measure: Change in wake time after sleep onset measured by polysomnography
timeFrame: Polysomnography is recorded one night before the intervention (baseline) and one night after the intervention (from 12 to 14 weeks after baseline, depending on the intervention).
measure: Change in number of awakenings measured by polysomnography
timeFrame: Polysomnography is recorded one night before the intervention (baseline) and one night after the intervention (from 12 to 14 weeks after baseline, depending on the intervention).
measure: Change in sleep efficiency measured by polysomnography
timeFrame: Polysomnography is recorded one night before the intervention (baseline) and one night after the intervention (from 12 to 14 weeks after baseline, depending on the intervention).
measure: Change in percentage of time spent in the different stages sleep measured by polysomnography
timeFrame: Polysomnography is recorded one night before the intervention (baseline) and one night after the intervention (from 12 to 14 weeks after baseline, depending on the intervention).
measure: Change in sleep quality measured by polysomnography
timeFrame: Polysomnography is recorded one night before the intervention (baseline) and one night after the intervention (from 12 to 14 weeks after baseline, depending on the intervention).
measure: Change in time in bed measured by actigraphy
timeFrame: Actigraphy is recorded continuously during one week before the intervention (baseline) and one week after the intervention (at 12 and / or 14 weeks after baseline, depending on the intervention).
measure: Change in sleep onset latency measured by actigraphy
timeFrame: Actigraphy is recorded continuously during one week before the intervention (baseline) and one week after the intervention (at 12 and / or 14 weeks after baseline, depending on the intervention).
measure: Change in total sleep time measured by actigraphy
timeFrame: Actigraphy is recorded continuously during one week before the intervention (baseline) and one week after the intervention (at 12 and / or 14 weeks after baseline, depending on the intervention).
measure: Change in wake time after sleep onset measured by actigraphy
timeFrame: Actigraphy is recorded continuously during one week before the intervention (baseline) and one week after the intervention (at 12 and / or 14 weeks after baseline, depending on the intervention).
measure: Change in sleep efficiency measured by actigraphy
timeFrame: Actigraphy is recorded continuously during one week before the intervention (baseline) and one week after the intervention (at 12 and / or 14 weeks after baseline, depending on the intervention).
measure: Change in sleep quality measured by actigraphy
timeFrame: Actigraphy is recorded continuously during one week before the intervention (baseline) and one week after the intervention (at 12 and / or 14 weeks after baseline, depending on the intervention).
Secondary outcomes:
measure: Change in quality of life
timeFrame: Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention)
measure: Change in state anxiety
timeFrame: Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention)
measure: Change in visual analog scale of anxiety
timeFrame: Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention)
measure: Change in the Geriatric Depression Scale
timeFrame: Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention)
measure: Change in cognitive functions: Stroop test
timeFrame: Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention)
measure: Change in cognitive functions: trail making test (TMT)
timeFrame: Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention)
measure: Change in cognitive functions: dual-task Baddeley
timeFrame: Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention)
measure: Change in long term memory
timeFrame: Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention)
measure: Change in Hand grip strength
timeFrame: Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention)
measure: Change in Leg extension power
timeFrame: Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention)
measure: Change in Postural balance
timeFrame: Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention)
measure: Change in maximum incremental cardiopulmonary test
timeFrame: Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention)
measure: Change in the Global Physical Activity Questionnaire (GPAQ)
timeFrame: Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention)
measure: Change in Timed up and go test
timeFrame: Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention)
Other outcomes:
Locations:
city: Caen
country: France
facility: Antoine Langeard
Study officials:
affiliation: Université de Caen Normandie, U1075 COMETE Inserm
name: Hervé Hervé, M.D. PhD.
role: PRINCIPAL_INVESTIGATOR
References: