A exploratory clinical trial to evaluate the efficacy on sleep during repeated exposure to lavender in the elderly subjects

JRCT ID: jRCT1061220100

Registered date:28/02/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Sleep quality improvement
• Date of first enrollment: 28/02/2023
• Target sample size: 12
• Study type: Interventional
• Intervention(s): Allocation to lavender group (lavender exposure during sleep for 7 days) and observation group (observation for 7 days)

Outcome(s)

• Primary Outcome: Quality of sleep

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable
• Gender: Male

Include 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

Exclude 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

Related Information

• Primary Sponsor: Iwata Masaaki
• Source(s) of Monetary Support: DAIKIN INDUSTRIES, LTD.,