Sweet Scents to Sweet Dreams (SSS)

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

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.

Study Overview

• Status: Completed
• Conditions: Sleep Disturbance; Mental Health Issue
• Intervention / Treatment: Other: Herbal Pillows

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15282
      • Duquesne University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Pillow	Other: Herbal Pillows; Pillows containing herbs
Active Comparator: Control Pillow	Other: Herbal Pillows; Pillows containing herbs
Experimental: Vata Pillow	Other: Herbal Pillows; Pillows containing herbs
Experimental: Pitta Pillow	Other: Herbal Pillows; Pillows containing herbs
Experimental: Kapha Pillow	Other: Herbal Pillows; Pillows containing herbs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Function	Assessments of rest/activity rhythms by wrist actigraphy	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject-reported effects on sleep	Assessments will be made using the validated sleep questionnaire, Pittsburgh Sleep Quality Index, PSQI	2 weeks
Subject-reported effects on depression	Assessments will be made using the validated depression questionnaire, Center for Epidemiology Studies-Depression, CES-D	2 weeks
Subject-reported effects on anxiety	Assessments will be made using the validated anxiety questionnaire, Spielberg State-Trait Anxiety Inventory, STAI	2 weeks
Subject-reported effects on stress	Assessments will be made using the validated stress questionnaire, Perceived Stress Scale, PSS	2 weeks
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
Ayurvedic assessments of doshas	Assessment of dosha-specific herbal pillows on dosha balancing	2 weeks

Collaborators and Investigators

• Sponsor: Duquesne University
• Collaborators: Cura Rest/Healing and Yoga Arts
• Investigators: Principal Investigator: Paula A. Witt-Enderby, Duquesne University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Actual): July 31, 2025
• Study Completion (Actual): July 31, 2025

Study Registration Dates

• First Submitted: January 23, 2024
• First Submitted That Met QC Criteria: January 30, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Parasomnias
• Other Study ID Numbers: 2023/11/25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Available upon reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No