N/A (healthy adults or adults with sleep disorder)
Conditions
Interventions
Using of mattress of Four-layer special three-dimensional structure
Sponsors
Anti-Aging Bank 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 [5]Individuals whose sleeping hours are over 4 hours from lights-out to rising and time of lights-out and rising is regular and bedtime is every 24th hours [6]Individuals who use a quilt [7]Individuals by whom going to bed by a single person is possible using in the test duration and a test mattress [8]Individuals whose written informed consent has been obtained [9]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 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 [9]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day) [10]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months [11]Individuals whose life style will change during the test period (ex. a night shift, travel for a long time, job transfer) [12]Individuals who participated in other clinical studies in the past three months [13]Individuals who are or are posslibly, or are lactating [14]Individuals judged inappropriate for the study by the principal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oxidative stress test (Week 0, Week 4) | — |
Secondary
| Measure | Time frame |
|---|---|
| [1]Sleep-related hormone test (Week 0, Week 4) [2]Immunity test (Week 0, Week 4) [3]Inflammatory test (Week 0, Week 4) [4]Japanese version of the Pittsburgh Sleep Quality Index (Week 0, Week 4) [5]Anti-Aging QOL Common Questionnaire (Week 0, Week 4) | — |
Countries
Japan
Contacts
Public ContactToshiyasu Tamura
TES Holdings Co., Ltd. Department of Clinical Trial
Outcome results
None listed