Evaluation of Quality of Sleep with SEIATSU (R) Mattress

Not Applicable

• Conditions: /A (healthy adults or adults with sleep disorder)

• Registration Number: JPRN-UMIN000020017
• Lead Sponsor: TES Holdings Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

[1]Individuals using medical products [2]Individuals who are suspected, recived treatment of, or have a history of sleep apnea syndrome [3]Individuals who have or are suspected with the night urination, prostatomegaly, or overactive bladder [4]Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease [5]Individuals with skin disease, such as atopic dermatitis [6]Individuals who have a history of hepatitis [7]Individuals with serious anemia [8]Individuals whose systolic blood pressure is over 160mmHg or diastolic pressure is over 100mmHg [9]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplyments in the past 3 month or will ingest those foods during the test period [10]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day) [11]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months [12]Individuals whose life style will change during the test period (ex. a night shift, travel for a long time, job transfer) [13]Individuals who participated in other clinical studies in the past three months [14]Individuals who are or are posslibly, or are lactating [15]Individuals judged inappropriate for the study by the principal

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
[1]Sleep-related hormone test (Week 0, Week 4) [2]Oxidative stress test (Week 0, Week 4) [3]Hormone metabolism and production test (Week 0, Week 4) [4]Endocrine system test (Week 0, Week 4) [5]Lipid metabolism test (Week 0, Week 4) [6]Glycometabolism test (Week 0, Week 4) [7]Liver function test (Week 0, Week 4) [8]Nitrogenous constituents test (Week 0, Week 4) [9]Electrolyte test (Week 0, Week 4) [10]Protein test (Week 0, Week 4) [11]Anemia test (Week 0, Week 4) [12]Japanese version of the Pittsburgh Sleep Quality Index (Screening, Week 0, Week 4) [13]OSA sleep inventory (Week 0, Week 4) [14]Anti-Aging QOL Common Questionnaire (Week 0, Week 4) [15]Sleep evaluation with sleepscan (Week 0, Week 4)

Secondary Outcome Measures

Name	Time	Method
[1]Blood pressure, pulsation (Screening, Week 0, Week 4) [2]Weight, body fat percentage, BMI (Screening, Week 0, Week 4) [3]Doctor's questions (Screening, Week 0, Week 4) [4]Subject's diary (From 7 days before using a test material to the last day of the test)