Detection of mental and physical conditions with heart rate variability
| ISRCTN | ISRCTN11112963 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11112963 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | UMIN000046352 |
| Sponsors | Kyocera (Japan), Kanazawa University |
| Funders | Kyocera (Japan), Kanazawa University |
- Submission date
- 08/05/2024
- Registration date
- 09/05/2024
- Last edited
- 27/01/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims.
Evaluating fatigue is essential in assessing mental, physical, and occupational health. However, there is no conclusive evidence of the usefulness of heart rate variability (HRV) in assessing mental fatigue. The aim of this study is to evaluate mental fatigue using HRV.
Who can participate?
Men and women aged 20 to 65 years who have received annual health check-ups and have been found to have no health concerns.
What does the study involve?
Participants are randomly allocated to either complete simple calculation tasks or to take a rest. HRV is measured using a wearable ECG monitor system. Fatigue and mood are measured before and after the intervention
What are the possible benefits and risks of participating?
Participants receive reasonable compensation. Participating takes about 3 hours.
Where is the study run from?
1. KYOCERA Corporation (Japan)
2. Kanazawa University (Japan)
When is the study starting and how long is it expected to run for?
April 2021 to September 2022
Who is funding the study?
1. KYOCERA Corporation (Japan)
2. Kanazawa University (Japan)
Who is the main contact?
Prof. Hiroaki Yoshikawa, hiroaki@staff.kanazawa-u.ac.jp
Contact information
Public, Scientific, Principal investigator
Kakumamachi
Kanazawa
920-1192
Japan
 ORCID ID |
0000-0002-6350-5183 |
|---|---|
| Phone | +81 (0)76 264 5254 |
| hiroaki@staff.kanazawa-u.ac.jp |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-center interventional randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Research on mental and physical conditions detected by heart rate variability analysis |
| Study acronym | RMPCDHRVA |
| Study objectives | Heart rate variability can detect mental fatigue. |
| Ethics approval(s) |
Approved 16/06/2021, Kanazawa University Medical Ethics Review Committee (13-1 Takaramachi, Kanazawa, 920-8640, Japan; +81 (0)76 265 2100; rinri@adm.kanazawa-u.ac.jp), ref: 2021-031 (3720) |
| Health condition(s) or problem(s) studied | Detection of mental fatigue in healthy adults |
| Intervention | Participants were randomized in a 1:1 ratio to the intervention or control groups using a computer-generated random number sequence for simple random allocation. Allocation concealment was ensured using sequentially numbered, opaque, sealed envelopes prepared by an independent research team member. The researchers compared heart rate variability (HRV) indexes after calculations with those after rest. They used Uchida-Kraepelin test (UKT) sheets for loading calculation tasks. The UKT is a serial addition test requiring participants to perform calculations as fast and accurately as possible within 30 min. This was achieved using pre-printed paper containing 15 lines of random, single-digit, horizontally aligned numbers. Participants were instructed to begin a new line for each minute of the test regardless of their position on the content line. Each line contained an excess of calculations such that the subjects could not finish any line for a particular minute before being prompted to move on to the start of the next minute by the examiner’s prompting. This test is usually performed for repeated 15 min of work and 5 min rest cycles. The researchers adopted four cycles. They used UKT sheets only to load mental fatigue and did not evaluate the scores. As a control, they asked participants to take a rest. The researchers prepared easy and calm books so participants could read them. The duration of rest was 80 minutes, adjusted to calculation tasks. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Heart rate variability (HRV) indexes measured using wearable electrocardiogram (ECG) devices before and after the intervention |
| Key secondary outcome measure(s) |
1. Fatigue measured using the visual analog scale (VAS) before and after the intervention |
| Completion date | 30/09/2022 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 20 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 150 |
| Total final enrolment | 140 |
| Key inclusion criteria | 1. Received annual health check-ups and found to have no health concerns 2. Aged 20-65 years |
| Key exclusion criteria | 1. Implanted cardiac pacemaker 2. Arrhythmia 3. Taking medicine that affects autonomic nervous functions, such as a beta-blocker |
| Date of first enrolment | 08/06/2022 |
| Date of final enrolment | 06/08/2022 |
Locations
Countries of recruitment
- Japan
Study participating centres
Kanazawa
920-1192
Japan
Yokohama
220-0012
Japan
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Published as a supplement to the results publication |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the results publication. The type of data that will be shared are the data obtained during the study in a spreadsheet format, and the approval form of the ethical committee. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 24/01/2025 | 27/01/2025 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
27/01/2025: Publication reference added.
25/10/2024: The intention to publish date was changed from 01/12/2024 to 01/12/2025.
08/05/2024: Study's existence confirmed by the Kanazawa University Medical Ethics Review Committee.
