UMIN-ICDS Clinical Trial

Public title

The Association Between Physical Condition, Stress Levels, Sleep Patterns, and Dietary Intake Measured by Smartwatches and the Onset of Headaches in Young Adults with Headaches

Acronym

The Association Between Physical Condition, Stress Levels, Sleep Patterns, and Dietary Intake Measured by Smartwatches and the Onset of Headaches in Young Adults with Headaches

Scientific Title

The Association Between Physical Condition, Stress Levels, Sleep Patterns, and Dietary Intake Measured by Smartwatches and the Onset of Headaches in Young Adults with Headaches

Scientific Title:Acronym

The Association Between Physical Condition, Stress Levels, Sleep Patterns, and Dietary Intake Measured by Smartwatches and the Onset of Headaches in Young Adults with Headaches

Region

Japan

Condition

Headache

Classification by specialty

Nursing

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Using subjective information and objective data collected via smartwatches, we will investigate the relationship between lifestyle factors-such as stress levels, sleep patterns, and dietary habits prior to the onset of headaches and vital signs,and their association with the occurrence of headaches. In addition to that, we will examine the differences between self-reported health status and objective health status measured by smartwatches, based on the severity of headaches.

Basic objectives2

Others

Basic objectives -Others

An observational study investigating the association between stress levels, sleep patterns, dietary intake, and vital signs measured by a smartwatch and the occurrence of headaches.

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

The onset of a headache

Key secondary outcomes

Headache severity (11-point scale), use of pain relievers, vital signs (pulse rate, resting heart rate, heart rate variability), sleep status (sleep duration, sleep stage/subjective sleep quality), subjective stress level, and whether or not a meal was consumed

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Shinshu University students aged 18 or older who had experienced headaches within three months prior to the survey and whose daily lives were affected as a result. Additionally, participants must have had a total score of 6 or higher on the MIDAS questionnaire (Japanese version).

Key exclusion criteria

(1)Severe headaches that make it difficult to continue the study
(2)A history of neurological disorders (such as epilepsy) or mental health conditions (such as sleep disorders) in addition to headaches, and currently undergoing treatment for these conditions

Target sample size

80

Name of lead principal investigator

1st name	Yoshihiro
Middle name
Last name	Asano

Organization

Shinshu University

Division name

The department of the Science of Fundamental Nursing, Nursing Division, Division of health sciences, Shinshu University Graduate School of Medicine

Zip code

390-8621

Address

3-1-1, Asahi, Matsumoto City, Naganao

TEL

0263-37-2377

Email

milet@shinshu-u.ac.jp

Name of contact person

1st name	Mizuki
Middle name
Last name	Shiohara

Organization

Shinshu university

Division name

The department of the Science of Fundamental Nursing, Nursing Division, Division of health sciences

Zip code

390-8621

Address

3-1-1, Asahi, Matsumoto City, Nagano

TEL

0263-37-3099

Homepage URL

Email

25ms102b@shinshu-u.ac.jp

Institute

Shinshu University

Institute

Department

Personal name

Organization

MEXT(Japan)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

the Ethical Committee for Medical and Biological Research of Shinshu University School of Medicine

Address

3-1-1, Asahi, Matsumoto City, Nagano

Tel

0263-37-2571

Email

mdrinri@shinshu-u.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

信州大学

Date of disclosure of the study information

2026

Year

04

Month

09

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

2026

Year

03

Month

25

Day

Date of IRB

Anticipated trial start date

2026

Year

05

Month

01

Day

Last follow-up date

2026

Year

08

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

1.Study Design
Prospective observational study
2.Recruitment Period
From the date of approval by the Ethical Committee for Medical and Biological Research of Shinshu University School of Medicine and authorization by the head of the research institution through August 31, 2026
3.Recruitment Method
Recruitment will be conducted through the posting of recruitment notices and verbal outreach by staff members not involved in educational evaluations or similar activities. The recruitment notice will include the contact information for the principal investigator and the research coordinator, and prospective participants will be asked to contact them.
4.Data Collection Methods
(1) Prospective participants will be briefed on the study using an information sheet, and written informed consent for study participation will be obtained.
(2) Participants who have given consent will be asked to complete a questionnaire regarding basic demographics and the MIDAS questionnaire to measure headache severity. Subsequently, participants will be provided with a record sheet for headache occurrence and daily activities, a smartwatch, and a linked tablet device, and will be asked to wear the smartwatch and keep records for one week. Participants will be asked to wear the smartwatch as much as possible. They will be informed that it is acceptable to remove it during activities such as bathing.
5.Measurement Items
(1) Basic Attributes
Student ID, Name, Gender, Age, Current Medical History, Past Medical History, Headache Symptoms, Frequency, Pain Intensity, History of Medical Consultation, Diagnosis, Medication Use, MIDAS
(2) Headaches
Presence of headaches, headache severity, use of analgesics
(3) Vital Signs
Pulse rate, resting heart rate, heart rate variability
(4) Sleep Status
Sleep duration, sleep stage, Subjective sleep quality
Using a 4-point scale (Slept very well, Slept fairly well, Didn't sleep very well, Didn't sleep at all)

Registered date

2026

Year

04

Month

09

Day

Last modified on

2026

Year

04

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070038