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

NCT05030389 | Unknown

• 1 other identifier: Université de Caen Normandie
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Aging

Keywords

Exercise; Biological rhythms; Vestibular stimulation

Outcome Measures

Primary Outcomes (13)

• Change in sleep onset latency measured by polysomnography

  Objective measure of sleep quantity expressed in minutes.

  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).

• Change in total sleep time measured by polysomnography

  Objective measure of sleep quantity expressed in minutes.

  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).

• Change in wake time after sleep onset measured by polysomnography

  Objective measure of sleep quantity expressed in minutes.

  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).

• Change in number of awakenings measured by polysomnography

  Objective measure of sleep quantity.

  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).

• Change in sleep efficiency measured by polysomnography

  Objective measure of sleep quantity expressed in % and defined as 100 \* total sleep time / time in bed.

  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).

• Change in percentage of time spent in the different stages sleep measured by polysomnography

  Objective measure of sleep quantity expressed in % of time spent in stage 1 sleep, stage 2 sleep, stage 3 sleep and in rapid eye movement (REM) sleep.

  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).

• Change in sleep quality measured by polysomnography

  Objective measure of sleep quality. The variable use to determine sleep quality is the sleep fragmentation index (SFI). SFI is defined as the total number of awakenings and any sleep stage shift divided by the total sleep time ; and expressed in number of events per hour.

  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).

• Change in time in bed measured by actigraphy

  Objective measure of sleep quantity, expressed in minutes and based on bedtime and wake time.

  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).

• Change in sleep onset latency measured by actigraphy

  Objective measure of sleep quantity expressed in minutes.

  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).

• Change in total sleep time measured by actigraphy

  Objective measure of sleep quantity expressed in minutes.

  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).

• Change in wake time after sleep onset measured by actigraphy

  Objective measure of sleep quantity expressed in minutes.

  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).

• Change in sleep efficiency measured by actigraphy

  Objective measure of sleep quantity expressed in % and defined as 100 \* total sleep time / time in bed.

  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).

• Change in sleep quality measured by actigraphy

  Objective measure of sleep quality. Actigraphic measure of sleep quality is the fragmentation index defined as the sum of the Mobile time (%) and the Immobile bouts \<=1min (%).

  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 (14)

• Change in quality of life

  Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention)

• Change in state anxiety

  Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention)

• Change in visual analog scale of anxiety

  Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention)

• Change in the Geriatric Depression Scale

  Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention)

• Change in cognitive functions: Stroop test

  Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention)

Study Arms (4)

Adapted Physical Activity (APA)

EXPERIMENTAL

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

Behavioral: Adapted Physical Activity (APA)

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

EXPERIMENTAL

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

Behavioral: Adapted Physical Activity (APA); Behavioral: Bright Light Exposure (BLE)

Galvanic Vestibular Stimulation (GVS)

EXPERIMENTAL

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

Behavioral: Galvanic Vestibular Stimulation (GVS)

Health Education program (HE)

ACTIVE COMPARATOR

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

Behavioral: Health Education program (HE)

Interventions

Adapted Physical Activity (APA) BEHAVIORAL

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

Bright Light Exposure (BLE) BEHAVIORAL

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.

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

Galvanic Vestibular Stimulation (GVS) BEHAVIORAL

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.

Galvanic Vestibular Stimulation (GVS)

Health Education program (HE) BEHAVIORAL

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.).

Health Education program (HE)

Eligibility Criteria

• Age: 60 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Université de Caen Normandie: lead
• Région Normandie: collaborator

Study Sites (1)

Antoine Langeard

Caen, 14000, France

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Hervé Hervé, M.D. PhD.

  Université de Caen Normandie, U1075 COMETE Inserm

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hervé Normand, M.D. PhD.

CONTACT

+33.231.56.82.14; herve.normand@unicaen.fr

Gaëlle Quarck, PhD

CONTACT

+33.231.56.82.14; gaelle.quarck@unicaen.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: September 1, 2021
• Study Start: January 25, 2021
• Primary Completion: June 1, 2022
• Study Completion: January 1, 2023
• Last Updated: September 1, 2021

Record last verified: 2021-07

Locations

FR (1)