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Sleep evaluation using the mobile sleep laboratory for human

Evaluation of sleep using the mobile sleep laboratory for human - Evaluation of sleep using the mobile sleep laboratory for human

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000040114
Enrollment
20
Registered
2020-04-09
Start date
2020-04-20
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

Healthy subject

Interventions

[Experiment 1] A.normal sleep laboratory B.mobile sleep laboratory Subjects stay 2 nights (total 4 nights/ subject) in each laboratory. The order of laboratory is (A,B). [Experiment 2] A.normal s

Sponsors

University of Tsukuba
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Participants will be included on the following all criteria. 1)Not having difficulty in filling out Japanese explanatory documents, consent forms, and survey forms 2)Being able to stay in the examination room on the 5th floor of the Innovative Medical Research Institute, University of Tsukuba, and the mobile human sleep laboratory at the Japan Automobile Research Institute. 3)Having no sleep disorder currently being treated 4)(Experiment 1 only) having never experienced sleep EEG recording (polysomnography, PSG)

Exclusion criteria

Exclusion criteria: Participants will be excluded from the experiment based on the following criteria. 1)Irregular lifestyle (Regular: sleep time between 9pm and 1am, wake time between 6am and 9am, 7-9 hours of sleep) 2)BMI less than 18.5 or greater than 25 3)Worked night shifts (after 10pm) 3 months prior to the experiment 4)Travel across time zones with time difference of 3 hours or more, 3 months prior to the experiment 5)Consumes alcohol regularly (40g (2 cans of beer) or more twice a week a more) 6)Smoker 7)Consumes more than 300mg (5 cups of 150mL) of coffee every day 8)Have possibilities that correspond to 1-7) above during the experiment period 9)MEQ score of less than 30 (extreme evening type) or greater than 70 (extreme morning type) 10)Pittsburgh Sleep Quality Index score of greater than 5.5 11)Have a disease that may change suddenly or its history 12)Claustrophobic 13)Pregnancy or its possibility 14)Lactation 15)Subjects judged by the investigator to be inappropriate

Design outcomes

Primary

MeasureTime frame
[Experiment 1] 1)Sleep variables such as sleep latency, percentage of sleep stages and wake after sleep onset evaluated by polysomnography 2)Spectral power density from frequency analysis using Electroencephalographic recordings for each sleep stage [Experiment 2] Spectral power density from frequency analysis using Electroencephalographic recordings for each sleep stage

Secondary

MeasureTime frame
[Experiment 1] 1)Evaluation of equivalence by inctraclass correlation coefficient and Bland-Altman analysis using sleep variables in the same room 2)Evaluation of equivalence by inctraclass correlation coefficient and Bland-Altman analysis using sleep variables in the different rooms 3)Questionnaires (Morning-Eveningness Questionnaire, Pittsburgh Sleep Quality Index and OSA sleep inventory) 4)Evaluation of sleep/wake using wrist-watch type actigraphy [Experiment 2] Questionnaires (Morning-Eveningness Questionnaire, Pittsburgh Sleep Quality Index and OSA sleep inventory) [Experiment 1,2] Vibration, noise, temperature and humidity

Countries

Japan

Contacts

Public ContactTakashi Abe

University of Tsukuba International Institute for Integrative Sleep Medicine (WPI-IIIS)

abe.takashi.gp@u.tsukuba.ac.jp029-859-1858

Outcome results

None listed

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