Sweet Scents to Sweet Dreams

NCT ID: NCT06247696

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2026-02-01

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.

Conditions

Sleep Disturbance; Mental Health Issue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Placebo Pillow

Group Type: PLACEBO_COMPARATOR

Herbal Pillows

Intervention Type: OTHER

Pillows containing herbs

Control Pillow

Group Type: ACTIVE_COMPARATOR

Herbal Pillows

Intervention Type: OTHER

Pillows containing herbs

Vata Pillow

Group Type: EXPERIMENTAL

Herbal Pillows

Intervention Type: OTHER

Pillows containing herbs

Pitta Pillow

Group Type: EXPERIMENTAL

Herbal Pillows

Intervention Type: OTHER

Pillows containing herbs

Kapha Pillow

Group Type: EXPERIMENTAL

Herbal Pillows

Intervention Type: OTHER

Pillows containing herbs

Interventions

Herbal Pillows

Pillows containing herbs

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cura Rest/Healing and Yoga Arts

UNKNOWN

Sponsor Role: collaborator

Duquesne University

OTHER

Sponsor Role: lead

Responsible Party

Paula Witt-Enderby

Professor of Pharmacology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paula A. Witt-Enderby

Role: PRINCIPAL_INVESTIGATOR

Duquesne University

Locations

Duquesne University

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

2023/11/25

Identifier Type: -

Identifier Source: org_study_id