UMIN-ICDS Clinical Trial

Public title

Sleep in Older Adults Undergoing Driver's License Renewal

Acronym

ODL Sleep Study

Scientific Title

Prevalence of Sleep-Disordered Breathing in Older Adults Undergoing Driver's License Renewal

Scientific Title:Acronym

OD-SDB Study

Region

Japan

Condition

Older adults undergoing driver's license renewal

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To determine the prevalence of sleep-disordered breathing, a risk factor for motor vehicle accidents, and to investigate the association between sleep status and driving behavior (including accident risk) in older drivers undergoing driver's license renewal. Participants will undergo home-based polysomnography (PSG) and complete questionnaires on sleep and driving behavior.

Basic objectives2

Others

Basic objectives -Others

To determine the prevalence rate and to investigate the association between sleep status and driving behavior

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

The prevalence of sleep-disordered breathing classified according to the apnea-hypopnea index (AHI) obtained from home-based polysomnography (PSG)

Key secondary outcomes

The association between driving behavior and sleep status

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

70

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Able to receive and return the study device by postal mail.
(2) Able to communicate by telephone in Japanese.
(3) Able to scan a QR code and view a video explaining the use of the study device using a smartphone or similar device, either independently or with assistance from a family member or caregiver.
(4) No apparent safety concerns that would preclude participation in the study.

Key exclusion criteria

(1) Individuals with psychiatric disorders or psychiatric symptoms that, in the opinion of the investigator, would make participation in the study difficult.
(2) Individuals who are not expected to be able to undergo home-based polysomnography (PSG) within 3 months after driver's license renewal.
(3) Individuals currently receiving treatment for sleep-disordered Breathing (SDB), including continuous positive airway pressure (CPAP) therapy.
(4) Individuals with a cardiac pacemaker.
(5) Individuals receiving home oxygen therapy.
(6) Individuals undergoing deep brain stimulation (DBS) for Parkinson's disease.
(7) Individuals with epilepsy.

Target sample size

500

Name of lead principal investigator

1st name	Hiromasa
Middle name
Last name	Ogawa

Organization

Tohoku University Hospital

Division name

Sleep Medicine Center Endowed Research on Division Geriatric Sleep Medicine and Social Safety Development

Zip code

980-8574

Address

1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan

TEL

022-717-7000

Email

hiromasa.ogawa.d2@tohoku.ac.jp

Name of contact person

1st name	Yuji
Middle name
Last name	Tanaka

Organization

Tohoku University/Tohoku University Hospital

Division name

New Industry Creation Hatchery Center Age-Adaptive Project for Centenarian Mobility

Zip code

980-0845

Address

6-6-10 Aramaki Aza Aoba, Aoba-ku, Sendai, Miyagi, Japan

TEL

022-795-5698

Homepage URL

Email

yuji.tanaka.a3@tohoku.ac.jp

Institute

Tohoku University

Institute

Department

Personal name

Organization

New Energy and Industrial Technology Development Organization

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Japan Sleep Medical Examination Association

Organization

Research Ethics Committee of the Institute for Excellence in Life Science and Medicine, Tohoku University

Address

2-1-1 Katahira, Aoba-ku, Sendai, Miyagi, Japan

Tel

022-215-3284

Email

tuhrp-soudan1@grp.tohoku.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

08

Month

01

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

Open public recruiting

Date of protocol fixation

2026

Year

04

Month

23

Day

Date of IRB

2026

Year

04

Month

23

Day

Anticipated trial start date

2026

Year

06

Month

23

Day

Last follow-up date

2030

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Older adults attending the Driver's License Center for driver's license renewal under the senior driver's license renewal program will be invited to participate in the study. Participants who provide written informed consent will undergo home-based polysomnography (PSG) and complete questionnaires on sleep and driving behavior. Approximately 500 participants will be enrolled by March 2028.

Registered date

2026

Year

07

Month

21

Day

Last modified on

2026

Year

07

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071285