UMIN-ICDS Clinical Trial

Public title

A study to develop a monitoring system that measures changes in finger movements and warns about excessive drinking

Acronym

HANDS: Hand Action for Noxious Drinking Screening

Scientific Title

Development of an IoT-Based System for Intoxication Level Assessment and Alerting via Finger Motion Change Detection

Scientific Title:Acronym

HANDS: Hand Action-based Notification and Drunkenness Screening

Region

Japan

Condition

Healthy adult volunteers under alcohol exposure

Classification by specialty

Psychiatry	Orthopedics	Emergency medicine

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

During alcohol consumption, characteristic changes in finger movement will be detected using a finger motion measurement device. This information will be used to evaluate alterations in finger movements during smartphone operation under drinking conditions. Based on these data, we will develop a smartphone application equipped with a machine learning-based intoxication detection function and an alert/warning function.

Basic objectives2

Others

Basic objectives -Others

A. Background and problem
Excessive alcohol use causes impaired judgment and acute intoxication, creating physical and social harm. Existing methods to estimate intoxication (wristbands, skin alcohol patches) depend on special devices that are not practical for daily life.

B. Scientific/technical approach
We have built machine learning tools that analyze finger motion and handwriting from smartphones and tablets to detect impaired fine motor control. This study will adapt those methods to detect alcohol-related loss of finger dexterity and to estimate intoxication level during real drinking using ordinary devices such as smartphones.

C. Expected social/clinical impact
Because this approach uses devices people already carry, real-world deployment is feasible. The system could warn the user, and possibly notify family or on-site staff, to prevent overdrinking and reduce alcohol-related harm.

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

Change in kinematic parameters of finger motion obtained from the smartphone-based handwriting task and thumb-movement task, including handwriting pressure, handwriting speed, variability, time to touch, and swipe speed

Key secondary outcomes

Subjective intoxication scale score (every 30 minutes)
Breath alcohol concentration (every 30 minutes)
Single-leg standing time (every 30 minutes)
Timed Up and Go (TUG) performance (every 30 minutes)
Blood pressure and peripheral oxygen saturation (SpO2) over time
Total alcohol intake at the end of the experiment

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Participants are healthy adults (>19 years old) who undergo baseline assessment in a sober state, including questionnaires on drinking habits and addiction screening, vital signs, and motor task performance. Each participant then consumes alcohol according to their usual drinking style after light food intake to avoid fasting intake. Every 30 minutes, until predefined stopping criteria are met (or up to 3 hours), the following are repeatedly assessed: peripheral oxygen saturation (SpO2), blood pressure, subjective intoxication score, single-leg standing time, Timed Up and Go (TUG) test, breath alcohol concentration, and two app-based motor tasks (handwriting tracing on a tablet and thumb-movement game on a smartphone). The pre-alcohol (sober) measurements serve as the within-subject control condition, and data obtained during alcohol exposure are compared against this baseline to evaluate intoxication-related changes in fine finger motion.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Age > 19 years at the time of consent.
Able to provide written informed consent for study participation.
Habitual alcohol consumption of at least once per month under usual conditions.

Key exclusion criteria

History of trauma to the upper limbs or cervical spine
Presence of neuromuscular disease, peripheral neuropathy, or any condition that affects finger motor function
Severe alcohol use disorder/ alcohol dependence, past history of alcohol abuse, or screening positive for dependence or suspected dependence on an alcohol dependence screening questionnaire
Pregnancy or breastfeeding
Ongoing psychiatric treatment, or continuous use of psychotropic medication (e.g., antipsychotics, benzodiazepines)
Hepatic dysfunction, or a history of diseases or pharmacological treatments that substantially affect alcohol metabolism
Low alcohol tolerance as determined by saliva-based DNA testing
Inability to rest on the morning following the experimental session
Living alone
Deemed unsuitable for participation by the principal investigator or subinvestigators

Target sample size

30

Name of lead principal investigator

1st name	Tomoyuki
Middle name
Last name	Kuroiwa

Organization

Graduate School of Medical and Dental Sciences, Institute of Science Tokyo

Division name

Department of Orthopaedic and Spinal Surgery

Zip code

1138510

Address

1-5-45, yushima, bunkyo-ku, Tokyo

TEL

0358035279

Email

kuroiwa.orth@tmd.ac.jp

Name of contact person

1st name	Tomoyuki
Middle name
Last name	Kuroiwa

Organization

Graduate School of Medical and Dental Sciences, Institute of Science Tokyo

Division name

Department of Orthopaedic and Spinal Surgery

Zip code

1138510

Address

1-5-45, yushima, bunkyo-ku, Tokyo

TEL

0358035279

Homepage URL

Email

kuroiwa.orth@tmd.ac.jp

Institute

Institute of Science Tokyo

Institute

Department

Personal name

Organization

Osake-no-Kagaku Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Medical Research Ethics Committee of Institute of Science Tokyo

Address

1-5-45, yushima, bunkyo-ku, Tokyo

Tel

0358034547

Email

rinri.adm@tmd.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

01

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2025

Year

10

Month

27

Day

Date of IRB

Anticipated trial start date

2026

Year

03

Month

30

Day

Last follow-up date

2026

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2025

Year

10

Month

27

Day

Last modified on

2026

Year

01

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068119