Recruiting

Observational StudyBeneficial Exposome Study

Sponsor:

Stanford University

Code:

NCT06093464

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Natural Compound A (Hinoki essential oil)

Natural Compound B (Lemon essential oil)

Natural Compound C (Control/Water)

Study Details

Brief summary:

The purpose of this study is to explore the positive, holistic health outcomes resulting from regular exposure to naturally occurring compounds predicted to have health benefits. The researchers hope to learn how the human body is influenced by regular exposure to these compounds.

Conditions

Healthy

Study ID

NCT06093464

Start date

Apr 16, 2024

Status verified date

Nov, 2024

Completion date

Apr, 2026

Anticipated

Primary completion date

Apr, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

18 years of age and older
Read, speak, and understand English
Live in the US territory

Exclusion Criteria:

Mental incapacity and/or cognitive impairment on the part of the patient that would preclude adequate understanding of, or cooperation with, the study protocol
Is pregnant
Is breastfeeding
Has epilepsy
Has allergies to Cupressaceae family of plants, common plants include redwoods, junipers, cypress, cedar, fir, and sequoia

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Group A- Natural Compound A to Natural Compound B to Natural Compound C

Cycle 1 (4 weeks): use diffused "Natural Compound A" (essential oil) in a diffuser every night when sleeping
Cycle 2 (4 weeks): will not use compounds/diffuser (wash-out period)
Cycle 3 (4 weeks): use diffused "Natural Compound B" (essential oil) in a diffuser every night when sleeping
Cycle 4 (4 weeks): will not use compounds/diffuser (post-intervention observation period)
Cycle 3 (4 weeks): use diffused "Natural Compound C" (control) in a diffuser every night when sleeping
Cycle 4 (4 weeks): will not use compounds/diffuser (post-intervention observation period)

There will be 3 natural compounds; the intervention compounds essential oils and are commercially available and there is a control compound (water). They will be used as intended with diffusers.

experimental: Group B- Natural Compound B to Natural Compound C to Natural Compound A

Cycle 1 (4 weeks): use diffused "Natural Compound B" (essential oil) in a diffuser every night when sleeping
Cycle 2 (4 weeks): will not use compounds/diffuser (wash-out period)
Cycle 3 (4 weeks): use diffused "Natural Compound C" (control) in a diffuser every night when sleeping
Cycle 4 (4 weeks): will not use compounds/diffuser (post-intervention observation period)
Cycle 3 (4 weeks): use diffused "Natural Compound A" (essential oil) in a diffuser every night when sleeping
Cycle 4 (4 weeks): will not use compounds/diffuser (post-intervention observation period)

There will be 3 natural compounds; the intervention compounds essential oils and are commercially available and there is a control compound (water). They will be used as intended with diffusers.

experimental: Group C- Natural Compound C to Natural Compound A to Natural Compound B

Cycle 1 (4 weeks): use diffused "Natural Compound C" (control) in a diffuser every night when sleeping
Cycle 2 (4 weeks): will not use compounds/diffuser (wash-out period)
Cycle 3 (4 weeks): use diffused "Natural Compound A" (essential oil) in a diffuser every night when sleeping
Cycle 4 (4 weeks): will not use compounds/diffuser (post-intervention observation period)
Cycle 3 (4 weeks): use diffused "Natural Compound B" (essential oil) in a diffuser every night when sleeping
Cycle 4 (4 weeks): will not use compounds/diffuser (post-intervention observation period)

There will be 3 natural compounds; the intervention compounds essential oils and are commercially available and there is a control compound (water). They will be used as intended with diffusers.

Interventions

Natural Compound A (Hinoki essential oil)

Participants will use "Natural Compound A" in a diffuser every night for 4 weeks. Diffuser will be placed near participant's bed and will be used during the entire time they are asleep (about 8 hours, every night).

Natural Compound B (Lemon essential oil)

Participants will use "Natural Compound B" in a diffuser every night for 4 weeks. Diffuser will be placed near participant's bed and will be used during the entire time they are asleep (about 8 hours, every night).

Natural Compound C (Control/Water)

Participants will use "Natural Compound C" in a diffuser every night for 4 weeks. Diffuser will be placed near participant's bed and will be used during the entire time they are asleep (about 8 hours, every night).

Primary outcome measure

Resting Heart Rate [ Time Frame: Baseline; 26 weeks ]
Heart Rate Variability [ Time Frame: Baseline; 26 weeks ]
Change in sleep quality measured as duration of sleep stages [ Time Frame: Baseline; 26 weeks ]
Profile of Mood States [ Time Frame: Baseline; weeks 2, 6, 10, 14, 18, 22, and 26 ]

Central Contacts and Locations

Central contacts

Ji Hyun Kim, MS

(650) 441-6216 jikimji@stanford.edu

Allison Zhang, PhD

zhangxy@stanford.edu

Locations

Stanford University

Recruiting

Palo Alto, California, United States, 94304

Contacts

Ji Hyun Kim, MS

650-441-6216 jikimji@stanford.edu

More Information

Sponsor

Stanford University

Last update posted

Dec 4, 2024

Last verified

Nov, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2024-12-04.