Non-invasive, Wearable Multi-parameter System for the Early Prediction of Cognitive Decline and Dementia in Older Adults
NCT04262674, Not applicable, Unknown, Empa, Swiss Federal Laboratories for Materials Science and Technology
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Non-invasive, Wearable Multi-parameter System for the Early Prediction of Cognitive Decline and Dementia in Older Adults | ClinicalTrials.gov |
| NCT number | NCT04262674 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 82 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Empa, Swiss Federal Laboratories for Materials Science and Technology | ClinicalTrials.gov |
| Conditions | Mild Cognitive Impairment, Healthy Aging | ClinicalTrials.gov |
| Interventions | Cognitive-motor training | ClinicalTrials.gov |
| First posted | 2020-02-10 | ClinicalTrials.gov |
| Last updated | 2021-02-04 | ClinicalTrials.gov |
Registered outcomes 8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Electroencephalography (EEG) | 30 minutes | EEG frequency bands (Hz) will be assessed during 10 minutes at rest in a seated position (5 min eyes closed, 5 min eyes open) and will be recorded using a wearable system covering the frontal, parietal, temporal, and occipital cortex and integrating 20 gel-pad electrode channels. The assessment will be continued during the subsequent gait protocol which consists of 8 minutes of walking back and forth at preferred speed on a 20 m track. | ClinicalTrials.gov |
| Primary | Gait speed analysis with inertial sensors | 15 minutes | The gait protocol consists of 8 minutes of walking back and forth at preferred speed on a 20 m track. Thereby, walking speed (m/s) will be assessed using inertial sensors attached to the feet. | ClinicalTrials.gov |
| Primary | Gait variability analysis with inertial sensors | 15 minutes | The gait protocol consists of 8 minutes of walking back and forth at preferred speed on a 20 m track. Thereby, step length variability (%) and step time variability (%) will be assessed using inertial sensors attached to the feet. | ClinicalTrials.gov |
| Primary | Heart rate variability (HRV) indices SDNN and RMSSD with two-lead electrocardiogram chest belt | 10 minutes | The HRV indices SDNN (ms) and RMSSD (ms) will be assessed during 10 minutes in a seated position, using a two-lead electrocardiogram chest belt. | ClinicalTrials.gov |
| Primary | Heart rate variability (HRV) index HF power with two-lead electrocardiogram chest belt | 10 minutes | The HRV index HF power (ms\^2) will be assessed during 10 minutes in a seated position, using a two-lead electrocardiogram chest belt. | ClinicalTrials.gov |
| Primary | Body temperature (T) with temperature sensors (thermistors) | 30 minutes | T will be assessed under controlled climatic conditions (22°C/40% relative humidity) measuring skin T (°C) at the scapula and the the ribs (lateral) using temperature sensors (thermistors) during 10 minutes sitting and 8 minutes walking as described above. | ClinicalTrials.gov |
| Secondary | Cognitive performance with neuropsychological tests | 1 hour | Neuropsychological tests will be performed to assess general cognitive performance (Quick Mild Cognitive Impairment screen), episodic memory (associative memory, Face-Name Associative Memory Exam, FNAME-12 test), semantic verbal fluency (category and letter fluency test), and executive functions (Trail Making Tests A/B, Stroop Test). The score of each test will be standardized and added up into a combined score of cognitive performance (z-score). | ClinicalTrials.gov |
| Secondary | Core body temperature (Tc) with telemetric gastrointestinal temperature pill | 16 hours | In a subgroup of 15 participants, Tc (°C) will be recorded with a telemetric gastrointestinal temperature pill over a period of 16 hours. | 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 5
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 |
|---|---|---|
| Face-name Memory Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | 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)