Sweet Scents to Sweet Dreams
- Conditions
- Mental Health IssueSleep Disturbance
- Interventions
- Other: Herbal Pillows
- Registration Number
- NCT06247696
- Lead Sponsor
- Duquesne University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Kapha Pillow Herbal Pillows - Pitta Pillow Herbal Pillows - Placebo Pillow Herbal Pillows - Control Pillow Herbal Pillows - Vata Pillow Herbal Pillows -
- Primary Outcome Measures
Name Time Method Sleep Function 2 weeks Assessments of rest/activity rhythms by wrist actigraphy
- Secondary Outcome Measures
Name Time Method Subject-reported effects on stress 2 weeks Assessments will be made using the validated stress questionnaire, Perceived Stress Scale, PSS
Subject-reported effects on quality of life 2 weeks Assessments will be made using the validated health-related quality of life questionnaire, quality of life (Health-related Quality of Life, HR-QOL
Subject-reported effects on depression 2 weeks Assessments will be made using the validated depression questionnaire, Center for Epidemiology Studies-Depression, CES-D
Subject-reported effects on sleep 2 weeks Assessments will be made using the validated sleep questionnaire, Pittsburgh Sleep Quality Index, PSQI
Ayurvedic assessments of doshas 2 weeks Assessment of dosha-specific herbal pillows on dosha balancing
Subject-reported effects on anxiety 2 weeks Assessments will be made using the validated anxiety questionnaire, Spielberg State-Trait Anxiety Inventory, STAI
Trial Locations
- Locations (1)
Duquesne University
🇺🇸Pittsburgh, Pennsylvania, United States