A randomized, double blind, placebo-controlled trial of Oxibarrier.
- Conditions
- Healthy subjects
- Registration Number
- JPRN-UMIN000010476
- Lead Sponsor
- Department of Somnology, Tokyo Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 30
Not provided
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (1) Sleep log (2) Athens Insomnia Scale
- Secondary Outcome Measures
Name Time Method (3) Actigraph (4) Pittsburgh sleep quality index (5) SF-8 acute