Healthy adults with subjective sleep dissatisfaction
Conditions
Sponsors
S'UIMIN Inc.
SOKEN Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy Japanese adult men and women aged 20 years to less than 70 years who are dissatisfied with their sleep, are engaged in full-time work including housework and childcare, are able to provide voluntary informed consent, have a habitual time in bed of more than 5 hours based on their usual self-reported bedtime and wake-up time, and are able to stay at the designated study venue for a specified period.
Exclusion criteria
Exclusion criteria: Individuals currently receiving treatment for any disease, including medication, except those with mild chronic conditions such as hypertension, diabetes, hyperlipidemia, gout, or asthma whose symptoms are stable with medication and do not interfere with work. Individuals diagnosed with sleep disorders such as insomnia or sleep apnea who are taking sleep-inducing or insomnia medications, including over-the-counter drugs, or are being treated with CPAP or oral appliances. Individuals unable to restrict intake during the study period of foods for specified health uses, foods with functional claims, supplements, or health foods that may affect the study. Individuals suspected of having severe chronic or acute infectious disease. Individuals planning vaccination during the study period. Night-shift workers or rotating-shift workers. Individuals unable to avoid alcohol consumption and caffeine-containing beverages after 6 p.m. on EEG measurement days. Individuals whose habitual time in bed is less than 5 hours. Individuals with extremely irregular dietary habits. Individuals with a BMI of 30 or higher. Individuals currently participating in another clinical study of drugs or health foods, within one month after completion of such a study, or planning to participate in another clinical study after consenting to this study. Individuals unable to stay at the designated study venue for a specified period. Any other individuals judged by the principal investigator to be inappropriate for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The average values for each of the two nights of measurement in the two housing conditions with different thermal insulation specifications will be calculated for the sleep quality parameters derived from each participant's sleep data (total sleep time, sleep efficiency, sleep latency, time spent awake during the night, total duration and percentage of deep sleep, etc.), and the differences between them will be evaluated. | — |
Secondary
| Measure | Time frame |
|---|---|
| Subjective sleep-related indices assessed using the OSA Sleep Inventory MA version will be compared between two residential conditions with different insulation specifications. Autonomic nervous system-related indices derived from heart rate variability during sleep will be exploratorily compared and analyzed between two residential conditions with different insulation specifications. Blood pressure measured after waking will be exploratorily compared between two residential conditions with different insulation specifications. | — |
Countries
Japan
Contacts
Public ContactShuji Nakamura
S'UIMIN Inc. Business Division
Outcome results
None listed