Sleep evaluation using the mobile sleep laboratory for huma

Not Applicable

• Conditions: Healthy subject

• Registration Number: JPRN-UMIN000040114
• Lead Sponsor: niversity of Tsukuba

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-09
• Study Completion: 2020-06-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
[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 Outcome Measures

Name	Time	Method
[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