UMIN-CTR Clinical Trial

Public title

Evaluation of the effects of an AI-based sleep service

Acronym

AI-Sleep Study

Scientific Title

Effects of an AI-based sleep service on sleep among workers

Scientific Title:Acronym

Effects of an AI-based sleep service on sleep among workers

Region

Japan

Condition

Healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the effectiveness of an AI-based sleep service for improving sleep among workers using a randomized controlled trial design.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The Athens Insomnia Scale

Key secondary outcomes

<Secondary Outcomes>
The Japanese version of the Epworth Sleepiness Scale
Subjective sleep restfulness
Presenteeism

<Secondary Outcomes: Daily during the intervention period (Intervention group only)>
Work shift (from last night to this morning)
Daily sleep duration (Bedtime and Wake-up time)
Subjective satisfaction with physical condition

<Eligibility Confirmation / Participant Characteristics>
Age (Date of birth), Sex
Years of continuous work / Employment duration
Family composition
Lifestyle and behavioral habits
Dietary patterns (Proportion of breakfast, lunch, and dinner)
Medication status
Sleep-related concerns/problems

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Participants will use an AI-based sleep service that provides:
1) personalized behavioral recommendations tailored to regular shift cycles and transitions;
2) weekly AI-generated feedback based on these recommendations;
3) automated data-entry reminders; and
4) AI-powered Q&A support and assistance with data interpretation.

Interventions/Control_2

No intervention

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

1. Healthy men and women aged 18 years or older.
2. Employees of a company (including both day-shift and shift workers).
3. Shift workers with a regular rotating shift schedule.

Key exclusion criteria

1. Individuals who have difficulty operating computers or smartphones at a level comparable to healthy individuals.
2. Individuals who participated in another clinical trial within the past month, or plan to participate in other clinical research after providing consent for this study.
3. Individuals with a history of, or current, serious diseases (e.g., diabetes, liver disease, kidney disease, heart disease, or cardiovascular disease).
4. Individuals currently receiving medical treatment for any disease, or those with a history of serious illness requiring medication.
5. Individuals unable to refrain from starting new use of health foods (including supplements affecting the cardiovascular system or metabolism), quasi-drugs, over-the-counter (OTC) drugs, or external analgesics/anti-inflammatory agents (such as poultices) during the study period.
6. Others judged ineligible for the study by their primary physician or the principal investigator.

Target sample size

35

Name of lead principal investigator

1st name	Karina
Middle name
Last name	Ando

Organization

EUPHORIA Co., Ltd.

Division name

Corporate Business Division

Zip code

102-0083

Address

10th Floor, Crystal City East Building, 4-8-1 Kojimachi, Chiyoda-ku, Tokyo

TEL

050-1744-7921

Email

karina.ando@eu-phoria.jp

Name of contact person

1st name	Sawa
Middle name
Last name	Kato

Organization

EUPHORIA Co., Ltd.

Division name

Corporate Business Division

Zip code

102-0083

Address

10th Floor, Crystal City East Building, 4-8-1 Kojimachi, Chiyoda-ku, Tokyo

TEL

050-1744-7921

Homepage URL

Email

sawa.kato@eu-phoria.jp

Institute

EUPHORIA Co., Ltd.

Institute

Department

Personal name

Organization

Shikoku Electric Power Co., Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Euphoria Institutional Review Board

Address

10th Floor, Crystal City East Building, 4-8-1 Kojimachi, Chiyoda-ku, Tokyo

Tel

050-1744-7921

Email

info-rinri@eu-phoria.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

04

Month

20

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

24

Day

Date of IRB

2026

Year

03

Month

24

Day

Anticipated trial start date

2026

Year

05

Month

08

Day

Last follow-up date

2027

Year

05

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

04

Month

17

Day

Last modified on

2026

Year

04

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069764