Sleep-Related Disease Digital Biomarker Exploratory Study

Digital Biomarker Exploratory Study using Fitbit in Japanese Volunteers

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1030230253

Enrollment

105

Registered

2023-07-25

Start date

2023-07-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Narcolepsy, Obstructive Sleep Apnea Syndrome, Healthy Volunteer Narcolepsy, Obstructive Sleep Apnea Syndrome, Healthy Volunteer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Japanese men and women who are 18 years of age or older at the time of obtaining consent (2) Able to lead an unrestricted daily life with no problems at all (3) ESS score less than 11

Exclusion criteria

Exclusion criteria: (1) Sleep-related comorbidities or complications (2) Must work irregular shifts or work at night (3) Difficulty in using or operating digital equipment

Design outcomes

Primary

Measure	Time frame
Similarity of characteristic shape and time-series patterns of wearable device data and self-assessment data	—

Secondary

Measure	Time frame
Safety assessment (adverse events)	—

Contacts

Public ContactJunichi Onuma

Aculys Pharma,Inc.

jonuma@aculys.com+81-90-3633-3970

Outcome results