Sweet Scents to Sweet Dreams

Sleep Disturbance Clinical Trial

— SSS  

Official title:

Sweet Scents to Sweet Dreams: Use of Herbal Pillows to Facilitate Sleep and Improve Quality of Life

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06247696
• Other study ID #: 2023/11/25
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: February 1, 2026

Study information

• Verified date: April 2024
• Source: Duquesne University
• Contact: Paula A. Witt-Enderby, Ph.D.
• Phone: 412-396-4346
• Email: wittp[@]duq.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 1, 2026
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dyssomnias
• Mental Health Issue
• Parasomnias
• Sleep Disturbance

Intervention

Other:
• Herbal Pillows
Pillows containing herbs

Locations

Country	Name	City	State
United States	Duquesne University	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Duquesne University	Cura Rest/Healing and Yoga Arts

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep Function	Assessments of rest/activity rhythms by wrist actigraphy	2 weeks
Secondary	Subject-reported effects on sleep	Assessments will be made using the validated sleep questionnaire, Pittsburgh Sleep Quality Index, PSQI	2 weeks
Secondary	Subject-reported effects on depression	Assessments will be made using the validated depression questionnaire, Center for Epidemiology Studies-Depression, CES-D	2 weeks
Secondary	Subject-reported effects on anxiety	Assessments will be made using the validated anxiety questionnaire, Spielberg State-Trait Anxiety Inventory, STAI	2 weeks
Secondary	Subject-reported effects on stress	Assessments will be made using the validated stress questionnaire, Perceived Stress Scale, PSS	2 weeks
Secondary	Subject-reported effects on quality of life	Assessments will be made using the validated health-related quality of life questionnaire, quality of life (Health-related Quality of Life, HR-QOL	2 weeks
Secondary	Ayurvedic assessments of doshas	Assessment of dosha-specific herbal pillows on dosha balancing	2 weeks