Clinical trial NCT06247696: Sweet Scents to Sweet Dreams
Official title: Sweet Scents to Sweet Dreams: Use of Herbal Pillows to Facilitate Sleep and Improve Quality of Life
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Disturbance
Mental Health Issue
Lead sponsor: Duquesne University
Sponsor class: OTHER
Collaborators: name: Cura Rest/Healing and Yoga Arts
First posted: 2024-02-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine the effect of herbal pillows on sleep and quality of life in a healthy population using actigraphy, validated questionnaires and daily diary logs. The goal of this study is to improve sleep and quality of life using herbal and Ayurveda/holistic-based botanical pillows.


Eligibility criteria: Inclusion Criteria:

* You must be at least 18 years of age.
* You must be willing to adhere to a sleep hygiene protocol (e.g., 10pm-midnight-6-8am) for 2 weeks without interruption in the comfort of your home.
* You must be willing to wear a watch that monitors your sleep and light as well as a sleep mask for two consecutive weeks.
* During the testing period, you must be willing to refrain from alcohol and anything that can affect mood and sleep.
* You must allow for the placement of an herbal pillow next to your head while sleeping for one week during testing.
* You must be willing to fill out short sleep logs during the 2 weeks of testing.
* You must also be willing to come to the study location on 3 occasions over a 2 week period.

Exclusion Criteria:

* Males or females with any condition that prevents adequate inhalation of botanical pillows \[e.g., Chronic Obstructive Pulmonary Disease (COPD), use of a Continuous Positive Airway Pressure (CPAP), deviated septum, etc\].
* Males or females on mood altering substances prescription (e.g., anti-depressants, anxiolytics, Ritalin, Adderall, anti-convulsants; opioids, etc), non-prescription/over-the-counter (OTC) drugs/herbal/natural products \[(e.g., tetrahydrocannabinol (THC)-containing compounds, melatonin, St. John's Wort, lavender capsules, essential oils, perfume-containing products, etc\].
* Any environmental, physical condition or pathology that can significantly impact on sleep and prevent an approximate 10pm-midnight-6-8am sleep rhythm (e.g., shift work, studying/exams, rotations, insomnia, new parents, nocturia, restless leg syndrome, chronic pain, etc).
* Any medications that can influence sleep \[(e.g., use of beta blockers; anti-histamines; dexamethasone; angiotensin converting enzyme inhibitor (ACEI); nicotine products, alpha blockers\]
* Chemical sensitivities
* Allergies
* Pregnancy.

Primary outcomes:
measure: Sleep Function
timeFrame: 2 weeks
Secondary outcomes:
measure: Subject-reported effects on sleep
timeFrame: 2 weeks
measure: Subject-reported effects on depression
timeFrame: 2 weeks
measure: Subject-reported effects on anxiety
timeFrame: 2 weeks
measure: Subject-reported effects on stress
timeFrame: 2 weeks
measure: Subject-reported effects on quality of life
timeFrame: 2 weeks
measure: Ayurvedic assessments of doshas
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Duquesne University
state: Pennsylvania
Study officials:
affiliation: Duquesne University
name: Paula A. Witt-Enderby
role: PRINCIPAL_INVESTIGATOR
References: