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An exploratory study of the effects of a pseudo-heartbeat generating device on sleep

An exploratory study of the effects of a pseudo-heartbeat generating device on sleep. - An exploratory study of the effects of a pseudo-heartbeat generating device on sleep.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000055417
Enrollment
30
Registered
2024-12-01
Start date
2024-11-01
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

Non

Interventions

The objective physiological index data such as HRV, SOL, SE, and sleep-wake rhythm before and after falling asleep will be collected using a wristwatch wearable device, and a questionnaire on subjecti

Sponsors

University of the Ryukyus
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Persons who meet all of the following criteria a) between 18 and 65 years of age b) Those who are in the borderline range of the Athens Insomnia Scale (total: 1 to 5 and Q1 is greater than 1) c) Those who are capable of wearing and using a wearable device and operating the electronic Patient Reported Outcome (ePRO) input operation.

Exclusion criteria

Exclusion criteria: Persons who meet all of the following criteria a) Patients with chronic diseases such as hypertension, diabetes mellitus, hyperlipidemia, sleep apnea syndrome, and psychiatric disorders who are being treated as outpatients. b) Persons who are judged to be unsuitable by the principal investigator c) Persons who have withdrawn their consent.

Design outcomes

Primary

MeasureTime frame
SOL on day 5 using a wearable device (wristwatch-type activity meter) with photoplethysmography (PPG) (64 oscillations/minute, which has been reported to be effective in previous studies).

Countries

Japan

Contacts

Public ContactYoshikazu Takaesu

University of the Ryukyus Lecture on Psychiatry, Graduate School of Medicine

takaesuy@med.u-ryukyu.ac.jp098-895-1157

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026