Sweet Scents to Sweet Dreams

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

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.

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 States

    Active - Recruiting

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