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An open-label, randomized, multicenter, exploratory clinical trial to evaluate the efficacy on sleep during repeated exposure to lavender in the elderly subjects

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

12

Twelve men aged 65 years or older were enrolled and randomized 1:1 to either a lavender group or a non-exposed group (Average age lavender group: 68.8 years, non-exposed group: 70.3 years).

All subjectss were enrolled on March 6, 2023, and observation for all subjects was completed on March 16, 2023. Twelve enrolled subjects completed the study, and no subjects were discontinued.

Twelve sunjects were included in the safety analysis. No adverse event was reported.

In the OSA Sleep Questionnaire MA version showed the lavender-exposed group rated their sleep better overall than the non-exposed group in terms of sleepiness upon waking, falling asleep and staying asleep, fatigue recovery, and sleep duration. Other subjective evaluations also showed generally better results in the lavender exposure group. No objective improvements in sleep were observed.

While the lavender group showed an improvement in subjective sleep state, no improvement was observed in objective indicators of sleep.

Dec. 31, 2025

No

None

https://jrct.mhlw.go.jp/latest-detail/jRCT1061220100

Iwata Masaaki

Tottori University Hospital

36-1 Nishi-cho, Yonago, Tottori Japan

yanmasa@f8.dion.ne.jp

Endo Yusuke

Tottori University Hospital

36-1 Nishi-cho, Yonago, Tottori Japan

+81-859-38-6946

y-endo@tottori-u.ac.jp

Complete

Feb. 28, 2023

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

parallel assignment

other

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

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

Male

Sleep quality improvement

Allocation to lavender group (lavender exposure during sleep for 7 days) and observation group (observation for 7 days)

Quality of sleep

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

+81-859-38-7014

Jan. 24, 2023

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