N/A (healthy adults or adults with sleep disorder)
Conditions
Interventions
Using of SEIATSU (R) mattress (4 weeks)
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1]Japanese males and females aged 40-65 years [2]Individuals who are healthy and are not received treatment of disease [3]Individuals whose BMI is 18.5-25.0 [4]Individuals who are not satisfy quality of sleep (ex. insomnia, interrupted sleep, early morning awakening, sleep disorder) [5]Individuals whose sleeping hours are over 4 hours from lights-out to rising [6]Individuals whose time of lights-out and rising is regular and bedtime is every 24th hours [7]Individuals who use a quilt [8]Individuals who can use a test mattress during the test period [9]Individuals who can sleep by him/herself during sleep evaluation period [10]Individuals whose written informed consent has been obtained [11]Individuals judged appropriate for the study by the principal
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| [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
| Measure | Time frame |
|---|---|
| [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) | — |
Countries
Japan
Contacts
Public ContactToshiyasu Tamura
TES Holdings Co., Ltd. Department of Clinical Trial
Outcome results
None listed