Sweet Scents to Sweet Dreams (SSS)

Duquesne University

Status: Active, not recruiting

Conditions: Mental Health Issue; Sleep Disturbance

Treatments: Other: Herbal Pillows

Study type: Interventional

Funder types: Other

Identifiers

NCT06247696

2023/11/25

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 5 patient groups, including a placebo group

Placebo Pillow

Placebo Comparator group

Treatment:

Other: Herbal Pillows

Control Pillow

Active Comparator group

Treatment:

Other: Herbal Pillows

Vata Pillow

Experimental group

Treatment:

Other: Herbal Pillows

Pitta Pillow

Experimental group

Treatment:

Other: Herbal Pillows

Kapha Pillow

Experimental group

Treatment:

Other: Herbal Pillows