Sleep quality improvement
Conditions
Interventions
Allocation to lavender group (lavender exposure during sleep for 7 days) and observation group (observation for 7 days)
Sponsors
Iwata Masaaki
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Japanese male over 65 years old 2) Subjects who are judged health by investigator screening test 3) Subjects who sleep at night and have regular sleep every day (stable bedtime and wake-up time) 4) Subjects who took an average of 15 minutes or more to fall asleep after deciding to sleep in the past month
Exclusion criteria
Exclusion criteria: 1) Subjects with hypersensitivity to the scent of lavender 2) Subjects who checked "Those who answered that they could not accept staying in a room filled with this scent for a long time" in the survey on scent preference at screening 3) Subjects with dysosmia or allergic rhinitis 4) Subjects with cognitive impairment 5) Subjects with a history of insomnia or other mental disease 6) Subjects with drug addicts or alcoholics 7) Subjects with serious disease 8) Subjects who drink excessively or who cannot keep alcohol abstinence during the study period 9) Subjects who have a history of smoking within 4 months before enrollment 10) Subjects who are aware of snoring or have been pointed out by their family about snoring 11) Subjects with hypersensitivity to alcohol disinfection 12) Subjects who had a positive with immune serological test at screening 13) Subjects who cannot agree to refrain from excessive activity during the study period 14) Subjects who participated in other clinical trials or clinical research within 3 months before registration and used unapproved or uninsured drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of sleep | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Environmental factors such as thermal sensation, itching, and pain 2) Scent adaptation 3) Heart rate and heart rate variability during sleep 4) Breathing during sleep 5) Sleep status 6) Biological reaction 7) Adolescent/Adult Sensory Profile 8) Profile of Mood States 9) State-Trait Anxiety Inventory 10) Psychosocial stress 11) Relevance between endpoints 12) Blood biomaker 13) Advese event | — |
Contacts
Public ContactYusuke Endo
Tottori University Hospital
Outcome results
None listed