Healthy AgingvelocceNCT05030389
Vestibular Stimulation, Exercise and Light Optimization for Circadian Clock Enhancement (Velocce)
A study testing Adapted Physical Activity (APA), Bright Light Exposure (BLE) and Galvanic Vestibular Stimulation (GVS) in people with Healthy Aging, run by Université de Caen Normandie at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- What is being tested?
- Adapted Physical Activity (APA), Bright Light Exposure (BLE) and Galvanic Vestibular Stimulation (GVS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jan 2021to Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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)
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- 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 locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Antoine Langeard
Caen, 14000
Antoine Langeard, PhD., +33231568214, antoine.langeard@unicaen.fr
Stéphane Réhel, PhD., +33231568214, stephane.rehel@unicaen.fr
About this study
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
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.
Read the 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
- Being tested
- Adapted Physical Activity (APA), Bright Light Exposure (BLE), Galvanic Vestibular Stimulation (GVS), Health Education program (HE)
- Keywords
- Exercise, Biological rhythms, Vestibular stimulation
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Physical Activity (APA)Behavioural
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)Behavioural
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)Behavioural
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)Behavioural
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.).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Behavioral: Health Education program (HE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sleep onset latency measured by polysomnography
Objective measure of sleep quantity expressed in minutes.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 (%).
Measured: 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
The French version of the SF-36 health survey (Leplège, 2001) includes 11 questions with 5-point rating scales.
This survey measures eight scales: physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. For each scale, a score from 0 to 100 is calculated : a higher score means a better quality of live.
Moreover, from these eight scales, two distinct concepts are measured by the SF-36:
- a physical dimension, represented by the Physical Component Summary (PCS), and
- a mental dimension, represented by the Mental Component Summary (MCS)
Measured: Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention)
Change in state anxiety
Part A of the State-Trait Anxiety Inventory (STAI-A ; Spielberger et al., 1970).
It consists in 20 statements for which volunteers have to evaluate how they feel at a particular moment in time.
Each answer is scored from 1 to 4, with 1 = low degree of anxiety, and 4 = high degree of anxiety.
Global score varies from 20 to 80, and means :
- from 20 to 35 : very low state anxiety
- from 36 to 45 : low state anxiety
- from 46 to 55 : medium state anxiety
- from 56 to 65 : high state anxiety
- from 66 to 80 : very high state anxiety
Measured: 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
Volunteers are asked to place a vertical mark on a 100-mm horizontal line, between "calm" (on the left edge) and "anxious" (on the right edge) (Abend et al., 2014).
Measured: 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
The Geriatric Depression Scale has been designed to specifically rate depression in older adults (Lach et al., 2010; Yesavage et al., 1982).
This scale includes 30 "yes / no" questions.
Global score varies between 0 and 30, and means :
- from 0 to 9 : no depression
- from 10 to 20 : minor depression
- from 21 to 30 : major depression
Measured: 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
Evaluation of selective attention. Stroop test has three parts:
- - Denomination condition: Volunteers have to name, as fast as possible, the color of rectangles printed in the card A.
- - Reading condition: Volunteers have to read, as fast as possible, words printed in black and white in the card B.
- - Interference condition: Volunteers have to name, as fast as possible, the color of the words printed in colors in the card C.
Dependant variables recorded in each condition:
- Time to perform the task
- Number of errors = number of self-corrected errors + non-self-corrected errors
Calculation of interference scores:
- Time in the Denomination condition - Time in the Interference condition
- Number of errors in the Denomination condition - Number of errors in the Interference condition
Measured: Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention)
Change in cognitive functions: trail making test (TMT)
Two parts:
- TMT-A: Processing speed: volunteers have to link, as fast as possible, numbers from 1 to 25 in sequential order.
- TMT-B: Flexibility : volunteers have to alternate, as fast as possible, between numbers from 1 to 13 and letters from A to L : 1-A-2-B-3-C, etc.
Dependant variables recorded in each part:
- Time to perform the task
- Number of errors for TMT-A = number of self-corrected errors + non-self-corrected errors
- Number of errors for TMT-B = number of self-corrected errors + non-self-corrected errors + perseverative errors
Scoring procedure:
- Time to perform TMT-B - Time to perform TMT-A
- Number of errors for TMT-B - Number of errors for TMT-A
Measured: Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention)
Change in cognitive functions: dual-task Baddeley
Assessment of working memory. First: determination of memory span. Single task 1: memory span for 2 minutes Single task 2: visuo spatial tracking task for 2 minutes Dual-task: both tasks are completed simultaneously for 2 minutes
Dependant variables recorded:
- Single task 1: number of correctly recalled series of items
- Single task 2: number of ticked boxes
Scoring procedure:
- Recall performance = (number of correctly recalled series of items during single task - number of correctly recalled series of items during dual-task) / number of correctly recalled series of items during single task.
- Tracking performance = (number of ticked boxes during single task - number of ticked boxes during dual task) / number of ticked boxes during single task.
- Mu index (index reflecting the performance decrement due to the dual-task) = (1-((Recall performance + Tracking performance)/2))*100. A high Mu index means high dual-task performance.
Measured: Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention)
Change in long term memory
Computerized memory task, based on the Memory game (Rasch et al., 2007) comprising 24 cards (12 pairs of similar cards).
Learning condition: Volunteers have to find pairs of identical cards. Learning is completed when volunteers reach at least 68% of correct answers, i.e. when 16 cards are correctly assembled on 24.
Recall condition takes place the next morning. Only one trial is performed.
Dependant variables recorded:
- Number of pairs correctly recalled during the learning condition
- Number of pairs correctly recalled the next morning
Scoring procedure:
- Delta index: (number of pairs correctly recalled the next morning - number of pairs correctly recalled during the learning condition) / number of pairs correctly recalled during the learning condition
Measured: Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention)
Change in Hand grip strength
The hand grip strength is measured with a dynamometer. Volunteers complete three trials per hand, during 3 to 5 secondes, with 1-minute break between each trial to minimize fatigue effects.
Among the six measures, maximum values of each hand are retained (expressed in kg).
Measured: Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention)
Change in Leg extension power
Leg extension power is assessed with the Nottingham power rig. Seated volunteers have to extend their tested leg (right leg) as fast and hard as possible by pushing unilaterally the footplate. There are eight trials, with 30-second break in between.
Dependant variables recorded:
- maximal leg power (expressed in watts)
- maximal leg power relative to the weight of the individual (expressed in watts/kg)
Measured: Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention)
Change in Postural balance
Postural balance is assessed through the Synapsys posturography system (Synapsys Inc.).
Volunteers stand on the Synapsys posturography system, feet apart, with their arms alongside their body, looking straight ahead.
Postural balance is measured in two conditions, with eyes open and eyes closed. There are two 30-second trials per condition.
For each trial, the position of the center of pressure (CoP) is recorded. Limit of stability test is recorded without time limitation. The maximum amplitude of oscillations of the CoP in mediolateral and anterioposterior directions are recorded.
Measured: Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention)
Change in maximum incremental cardiopulmonary test
The maximum incremental cardiopulmonary test is performed on an ergometric bicycle, based on an individualized protocol.
Prior to the test, a resting ECG is performed and verified by a cardiologist. Following a 3 min warm-up (30 watts), the power is incremented by 20 watts every 2 minutes until exhaustion. The test is followed by a 3-minute recovery period.
Maximum effort is determined by the occurrence of the following two criteria:
- 1) Presence of a VO2 plateau despite an increase of power (Åstrand et al., 1994);
- 2) Increase in oxygen consumption of the last increment should not exceed 100 ml/min despite the increase in power (Di Prampero et al., 1993).
Dependant variables recorded:
- Maximum oxygen consumption (VO2 max)
- Maximum aerobic power
- Maximum heart rate
- Respiratory quotient (RQ) at the end of test (RQ = Volume of CO2 / Volume of O2)
Measured: Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention)
Change in the Global Physical Activity Questionnaire (GPAQ)
Questionnaire developed by the World Health Organization, which consists in 19 questions grouped to capture physical activity undertaken in different behavioural domains, as work, transport and discretionary (also known as leisure or recreation) (Cleland and al., 2014).
Within the work and discretionary domains, questions assess the frequency and duration of two different categories of activity defined by the energy requirement or intensity (vigorous or moderate intensity).
In the transport domain, the frequency and duration of all walking and cycling for transport is captured but no attempt is made to differentiate between these activities.
One additional item collects time spent in sedentary activities.
Calculation of a global MET score (Metabolic Equivalent of Task, 1 MET = 1 kcal/kg/hour).
Higher MET score means high physical activity.
Measured: Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention)
Change in Timed up and go test
Assessment of dynamic balance in the older adults (Mathias et al., 1986; Podsiadlo \& Richardson, 1991).
Volunteers are asked to sit down on a chair with their feet on the floor and their hands on their legs. At the "go" signal, they have to stand up, walk 3 meters, turn around a cone, walk back, and sit down again.
The performance time starts when volunteers start moving to stand up and ends when they sit down again properly.
The test is performed in two conditions:
- Two trials at a self-paced velocity, and
- Two trials as fast as possible
Duration of the two best trials of the two conditions are retained (Podsiadlo \& Richardson, 1991).
Measured: Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start25 Jan 2021
- Primary completionJun 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Caen Normandie
- Sponsor type
- University, hospital or other
- Collaborators
- Région Normandie
- Responsible party
- Sponsor
- Investigators
- Hervé Hervé, M.D. PhD., Principal investigator, Université de Caen Normandie, U1075 COMETE Inserm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05030389
- Sponsor's protocol ID
- Université de Caen Normandie
- Acronym
- velocce
- Status last verified
- Jul 2021
- First submitted
- 25 Jun 2021
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05030389
- Acronym / sponsor ID
- velocce / Université de Caen Normandie
- Conditions
- Healthy Aging
- Keywords
- Exercise, Biological rhythms, Vestibular stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Université de Caen NormandieUniversity, hospital or other
- Collaborators
- Région Normandie
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 1 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Adapted Physical Activity (APA) | Experimental | Behavioral: 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 + Bright Light Exposure (APA + BLE) | Experimental | Behavioral: Adapted Physical Activity (APA), Behavioral: Bright Light Exposure (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 |
| Galvanic Vestibular Stimulation (GVS) | Experimental | Behavioral: Galvanic Vestibular Stimulation (GVS)Participants receive Galvanic Vestibular Stimulation (GVS) during two weeks, on the basis of five at-home sessions a week |
| Health Education program (HE) | Active comparator | Behavioral: 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 |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Adapted Physical Activity (APA), Adapted Physical Activity + Bright Light Exposure (APA + BLE) |
| 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. | Behavioural | Adapted Physical Activity + Bright Light Exposure (APA + BLE) |
| 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. | Behavioural | Galvanic Vestibular Stimulation (GVS) |
| 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.). | Behavioural | Health Education program (HE) |
Primary outcome
Change in sleep onset latency measured by polysomnography
Time frame: 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).
Objective measure of sleep quantity expressed in minutes.
Change in total sleep time measured by polysomnography
Time frame: 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).
Objective measure of sleep quantity expressed in minutes.
Change in wake time after sleep onset measured by polysomnography
Time frame: 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).
Objective measure of sleep quantity expressed in minutes.
Change in number of awakenings measured by polysomnography
Time frame: 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).
Objective measure of sleep quantity.
Change in sleep efficiency measured by polysomnography
Time frame: 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).
Objective measure of sleep quantity expressed in % and defined as 100 * total sleep time / time in bed.
Change in percentage of time spent in the different stages sleep measured by polysomnography
Time frame: 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).
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.
Change in sleep quality measured by polysomnography
Time frame: 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).
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.
Change in time in bed measured by actigraphy
Time frame: 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).
Objective measure of sleep quantity, expressed in minutes and based on bedtime and wake time.
Change in sleep onset latency measured by actigraphy
Time frame: 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).
Objective measure of sleep quantity expressed in minutes.
Change in total sleep time measured by actigraphy
Time frame: 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).
Objective measure of sleep quantity expressed in minutes.
Change in wake time after sleep onset measured by actigraphy
Time frame: 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).
Objective measure of sleep quantity expressed in minutes.
Change in sleep efficiency measured by actigraphy
Time frame: 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).
Objective measure of sleep quantity expressed in % and defined as 100 * total sleep time / time in bed.
Change in sleep quality measured by actigraphy
Time frame: 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).
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 (%).
14 secondary outcomes
Change in quality of life
Time frame: Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention)
Change in state anxiety
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention)
Change in cognitive functions: trail making test (TMT)
Time frame: Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention)
Change in cognitive functions: dual-task Baddeley
Time frame: Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention)
Change in long term memory
Time frame: Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention)
Change in Hand grip strength
Time frame: Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention)
Change in Leg extension power
Time frame: Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention)
Change in Postural balance
Time frame: Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention)
Change in maximum incremental cardiopulmonary test
Time frame: Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention)
Change in the Global Physical Activity Questionnaire (GPAQ)
Time frame: Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention)
Change in Timed up and go test
Time frame: Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hervé Hervé, M.D. PhD. principal investigator
Université de Caen Normandie, U1075 COMETE Inserm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted Physical Activity (APA), Bright Light Exposure (BLE) and Galvanic Vestibular Stimulation (GVS) in people with Healthy Aging, run by Université de Caen Normandie at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hervé Normand, M.D. PhD. (+33.231.56.82.14, herve.normand@unicaen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sleep onset latency measured by polysomnography (time frame: 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).). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.