Evaluation of a consumer wearable device compared to polysomnography for detecting sleep

JRCT ID: jRCT1030210486

Registered date:16/12/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: An exploration of wearable devices for sleep evaluation in healthy people
• Date of first enrollment: 16/12/2021
• Target sample size: 100
• Study type: Observational
• Intervention(s): N/A

Outcome(s)

• Primary Outcome: Validity of Sleep Information Data Obtained from Wearable Devices and Polysomnography (Simplified PSG)
• Secondary Outcome: Correlation between the information obtained from the wearable device and the simple PSG and the subjective assessment items of the questionnaire

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 70age old
• Gender: Both

Include criteria

1. Japanese between 20 to 70 years old
2. BMI between 18-30
3. No evidence of sleep pathology
a..STOP-Bang score (Q1-Q4) < 2 at pre-screen and STOP-Bang score (Q1-Q8) < 3 at visit 1 (V1)
b. Epworth Sleepiness Scale < 10
c. GSDS average score < 3
4. No diagnosed sleep disorder
5. Ability to read and understand the written consent form
6. Willing and able to cooperate with the study procedures for the duration of the study
7. Able to communicate and comprehend study instructions
8. Must have been using a smartphone for at least 6 months prior to the start of the study
9. Willing and able to apply PSG sensors prior to each night of sleep
10. Typical hours of sleep in the last month are between the hours of 8PM and 10AM

Exclude criteria

1.Participants with known skin problems, such as allergic skin reactions, active eczema, or contagious skin conditions.
2.Participants with known sleep disorders (including sleep apnea, periodic limb movement disorder, insomnia, or narcolepsy)
3.Known allergies or previous reaction to titanium or medical-grade plastic
4.Current active illness (e.g. cold, flu, bronchitis, or suspected COVID-19)
5. Implanted device (e.g. cardiac pacemaker, deep brain stimulator, etc.)
6.Diagnosed psychoses (including Bipolar disorder and Schizophrenia)
7.Any other medical or psychiatric condition that PI deems exclusionary
8.Epworth Sleepiness Scale > 10
9.Symptoms of sleep disordered breathing
10.Current pregnancy
11.Participant who routinely sleeps less than 5 hours each night
12.Current shift or night work
13.Has traveled through time zones in the past 4 weeks
14.Those who are unable to refrain from consuming alcohol or energy drinks during the study period
15.Is planning to be away from home for an extended period of time during the study period
16.Participants who need to take sleep-inducing medication / sleep supplements (e.g., ornithine) during the study period
17.Current use (within last month) of the following medications/classes:
a.Stimulants (Ritalin)
b.Non-stimulant wake-promoting agents (e.g. pitolisant, etc.)
c.Antihistamines

Related Information

• Primary Sponsor: Svensson Kishi Akiko
• Source(s) of Monetary Support: The University of Tokyo, Research fund from Japan Science and Technology Agency