An exploration of wearable devices for sleep evaluation in healthy people
Conditions
Interventions
None listed
Sponsors
Svensson Kishi Akiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Validity of Sleep Information Data Obtained from Wearable Devices and Polysomnography (Simplified PSG) | — |
Secondary
| Measure | Time frame |
|---|---|
| Correlation between the information obtained from the wearable device and the simple PSG and the subjective assessment items of the questionnaire | — |
Contacts
Public ContactHirofumi Yoshikoshi
ACCERISE
Outcome results
None listed