Sleep-Related Disease Digital Biomarker Exploratory Study

JRCT ID: jRCT1030230253

Registered date:25/07/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Narcolepsy, Obstructive Sleep Apnea Syndrome, Healthy Volunteer
• Date of first enrollment: 25/07/2023
• Target sample size: 105
• Study type: Observational

Outcome(s)

• Primary Outcome: Similarity of characteristic shape and time-series patterns of wearable device data and self-assessment data
• Secondary Outcome: Safety assessment (adverse events)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude criteria

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

Related Information

• Primary Sponsor: Kumagai Takuya