Last updated: April 25, 2024
Sponsor: Duquesne University
Overall Status: Active - Recruiting
Phase
N/A
Condition
Restless Leg Syndrome
Sleep Disorders
Insomnia
Treatment
Herbal Pillows
Clinical Study ID
NCT06247696
2023/11/25
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 asleep mask for two consecutive weeks.
- During the testing period, you must be willing to refrain from alcohol and anythingthat can affect mood and sleep.
- You must allow for the placement of an herbal pillow next to your head while sleepingfor 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 weekperiod.
Exclusion
Exclusion Criteria:
- Males or females with any condition that prevents adequate inhalation of botanicalpillows [e.g., Chronic Obstructive Pulmonary Disease (COPD), use of a ContinuousPositive 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, lavendercapsules, essential oils, perfume-containing products, etc].
- Any environmental, physical condition or pathology that can significantly impact onsleep 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
Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Herbal Pillows
Phase:
Study Start date:
February 01, 2024
Estimated Completion Date:
February 01, 2026
Connect with a study center
Duquesne University
Pittsburgh, Pennsylvania 15282
United StatesActive - Recruiting
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