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Behavioural Intervention

Herbal Pillows for Sleep Disorders (SSS Trial)

N/A
Recruiting
Led By Paula A. Witt-Enderby
Research Sponsored by Duquesne University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must be at least 18 years of age
Be older than 18 years old
Must not have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks

Summary

"This trial aims to see if using herbal pillows can help improve sleep and quality of life in healthy individuals. They will be using tools like actigraphy, questionnaires, and daily diaries to measure the

Who is the study for?
This trial is for healthy individuals experiencing sleep issues or poor quality of life due to mental health concerns. Participants should be interested in trying holistic approaches like Ayurveda.
What is being tested?
The study is testing whether sleeping on herbal pillows can improve sleep and overall well-being. It involves tracking sleep patterns with actigraphy, answering questionnaires, and keeping a daily diary.
What are the potential side effects?
Since this trial uses non-invasive herbal pillows, side effects are expected to be minimal but may include allergic reactions or discomfort due to the scent or pillow material.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot inhale properly due to a condition like COPD or using a CPAP machine.
Select...
I am currently taking medication or products that affect my mood.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Sleep Function
Secondary study objectives
Ayurvedic assessments of doshas
Subject-reported effects on anxiety
Subject-reported effects on depression
+3 more

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Vata PillowExperimental Treatment1 Intervention
Group II: Pitta PillowExperimental Treatment1 Intervention
Group III: Kapha PillowExperimental Treatment1 Intervention
Group IV: Control PillowActive Control1 Intervention
Group V: Placebo PillowPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Duquesne UniversityLead Sponsor
31 Previous Clinical Trials
2,434 Total Patients Enrolled
Cura Rest/Healing and Yoga ArtsUNKNOWN
Paula A. Witt-EnderbyPrincipal InvestigatorDuquesne University
~4 spots leftby Feb 2025
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