Mental Health Issue, Sleep Disturbance
Conditions
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.
Interventions
OTHERHerbal Pillows
Pillows containing herbs
Sponsors
Duquesne University
Cura Rest/Healing and Yoga Arts
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Function | 2 weeks | Assessments of rest/activity rhythms by wrist actigraphy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject-reported effects on sleep | 2 weeks | Assessments will be made using the validated sleep questionnaire, Pittsburgh Sleep Quality Index, PSQI |
| 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 anxiety | 2 weeks | Assessments will be made using the validated anxiety questionnaire, Spielberg State-Trait Anxiety Inventory, STAI |
| 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 |
| Ayurvedic assessments of doshas | 2 weeks | Assessment of dosha-specific herbal pillows on dosha balancing |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPaula A. Witt-Enderby
Duquesne University
Outcome results
None listed