Vestibular Stimulation, Exercise and Light Optimization for Circadian Clock Enhancement (Velocce)
NCT05030389, Not applicable, Unknown, Université de Caen Normandie
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Vestibular Stimulation, Exercise and Light Optimization for Circadian Clock Enhancement (Velocce) | ClinicalTrials.gov |
| NCT number | NCT05030389 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 100 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Université de Caen Normandie | ClinicalTrials.gov |
| Conditions | Healthy Aging | ClinicalTrials.gov |
| Interventions | Adapted Physical Activity (APA), Bright Light Exposure (BLE), Galvanic Vestibular Stimulation (GVS), Health Education program (HE) | ClinicalTrials.gov |
| First posted | 2021-09-01 | ClinicalTrials.gov |
| Last updated | 2021-09-01 | ClinicalTrials.gov |
Registered outcomes 27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in sleep onset latency measured by polysomnography | 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. | ClinicalTrials.gov |
| Primary | Change in total sleep time measured by polysomnography | 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. | ClinicalTrials.gov |
| Primary | Change in wake time after sleep onset measured by polysomnography | 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. | ClinicalTrials.gov |
| Primary | Change in number of awakenings measured by polysomnography | 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. | ClinicalTrials.gov |
| Primary | Change in sleep efficiency measured by polysomnography | 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. | ClinicalTrials.gov |
| Primary | Change in percentage of time spent in the different stages sleep measured by polysomnography | 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. | ClinicalTrials.gov |
| Primary | Change in sleep quality measured by polysomnography | 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. | ClinicalTrials.gov |
| Primary | Change in time in bed measured by actigraphy | 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. | ClinicalTrials.gov |
| Primary | Change in sleep onset latency measured by actigraphy | 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. | ClinicalTrials.gov |
| Primary | Change in total sleep time measured by actigraphy | 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. | ClinicalTrials.gov |
| Primary | Change in wake time after sleep onset measured by actigraphy | 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. | ClinicalTrials.gov |
| Primary | Change in sleep efficiency measured by actigraphy | 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. | ClinicalTrials.gov |
| Primary | Change in sleep quality measured by actigraphy | 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 (%). | ClinicalTrials.gov |
| Secondary | Change in quality of life | Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention) | 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) | ClinicalTrials.gov |
| Secondary | Change in state anxiety | Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention) | 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 | ClinicalTrials.gov |
| Secondary | 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) | 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). | ClinicalTrials.gov |
| Secondary | 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) | 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 | ClinicalTrials.gov |
| Secondary | 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) | Evaluation of selective attention. Stroop test has three parts: 1. \- Denomination condition: Volunteers have to name, as fast as possible, the color of rectangles printed in the card A. 2. \- Reading condition: Volunteers have to read, as fast as possible, words printed in black and white in the card B. 3. \- 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 | ClinicalTrials.gov |
| Secondary | Change in cognitive functions: trail making test (TMT) | Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention) | Two parts: 1. TMT-A: Processing speed: volunteers have to link, as fast as possible, numbers from 1 to 25 in sequential order. 2. 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 | ClinicalTrials.gov |
| Secondary | Change in cognitive functions: dual-task Baddeley | Before the intervention (= baseline) and after the intervention (from 12 to 14 weeks after baseline, depending on the intervention) | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)