Healthy subjects
Conditions
Interventions
Taking Oxibarrier for two weeks, and then taking Placebo for two weeks after wash-out for two weeks.
Taking Placebo for two weeks, and then taking Oxibarrier for two weeks after wash-out for two weeks
Sponsors
Department of Somnology, Tokyo Medical University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1) subjective complaint of difficulties initiating (sleep latency >30 min) or maintaining sleep (time awake after sleep onset >30 min) for a month. (2) general good health without evidence of clinically significant disease as determined by medical history, physical examination, and urine drug screens. (3) The score of Pittsburgh sleep quality index: 5-8
Exclusion criteria
Exclusion criteria: (1) disease that could affect the action of the study (2) current or past history of serious, severe, or unstable physical (eg, congestive heart failure, chronic obstructive pulmonary disease, diabetes, thyroid disease) or psychiatric illness (eg, major depression, generalized anxiety disorder) (3) evidence of another sleep disorder (eg, sleep apnea, restless legs syndrome, periodic limb movements), irregular sleep patterns, or occupations involving evening or night shift work (4) allergies or suspected intolerance to the study medications or any antihistamines (5) current use of substances or medications known to affect sleep, including prescription psychotropics, sedatives, hypnotics, nicotine-replacement therapies, over-the-counter sleep aids, or herbal products (6) current or recent (within 1 year) alcohol or drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1) Sleep log (2) Athens Insomnia Scale | — |
Secondary
| Measure | Time frame |
|---|---|
| (3) Actigraph (4) Pittsburgh sleep quality index (5) SF-8 acute | — |
Countries
Japan
Contacts
Public ContactYoko Komada
Tokyo Medical University Department of Somnology
Outcome results
None listed