Insomnia
Conditions
Interventions
None listed
Sponsors
Shiga University of Medical Science
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adult male and female with sleep difficulty
Exclusion criteria
Exclusion criteria: -Patient having psychiatric disorders other than sleep disorder -Patient having sleep disorder other than insomnia disorders (hypersomnolence disorder, breathing- related sleep disorders, parasomnias. etc.) -Patient having caused the body trouble by periocular warming in the past -Patient having following diseases; cardiovascular disease, a neuropsychiatric disorder (alcohol/drug dependence or abuse, a suicide feeling, and the past attempted suicide history), an allergy disease, a kidney and urological diseases -Patient having following lifestyle; habitual drinking, shift worker, traveling abroad -The woman under pregnancy and breast-feeding, or the woman who may have become pregnant -Taking part in and will be going to take part in the other clinical trials during the study period. -Patients who are determined unsuitable by principal investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Pittsburgh Sleep Quality Index (PSQI) global score and component score of sleep latency | — |
Secondary
| Measure | Time frame |
|---|---|
| -Self-reported sleep status -The changes of the EEG sleep variables (Sleep latency, Wake after sleep onset, Total sleep time, Sleep efficiency, each sleep stage, etc) -The changes of the frequency calculated by EEG -The changes of heart rate and heart rate variability by obtained ECG -The changes of respiration rate -The changes of body temperature -The Activity-based sleep monitor | — |
Countries
Japan
Contacts
Public ContactTomohisa Ichiba
Kao Corporation Personal Health Care Research
Outcome results
None listed