NCT06247696

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

February 1, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 8, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

1.5 years

First QC Date

January 23, 2024

Last Update Submit

April 14, 2026

Conditions

Sleep DisturbanceMental Health Issue

Outcome Measures

Primary Outcomes (1)

  • Sleep Function

    Assessments of rest/activity rhythms by wrist actigraphy

    2 weeks

Secondary Outcomes (6)

  • Subject-reported effects on sleep

    2 weeks

  • Subject-reported effects on depression

    2 weeks

  • Subject-reported effects on anxiety

    2 weeks

  • Subject-reported effects on stress

    2 weeks

  • Subject-reported effects on quality of life

    2 weeks

  • +1 more secondary outcomes

Study Arms (5)

Placebo Pillow

PLACEBO COMPARATOR
Other: Herbal Pillows

Control Pillow

ACTIVE COMPARATOR
Other: Herbal Pillows

Vata Pillow

EXPERIMENTAL
Other: Herbal Pillows

Pitta Pillow

EXPERIMENTAL
Other: Herbal Pillows

Kapha Pillow

EXPERIMENTAL
Other: Herbal Pillows

Interventions

Herbal PillowsOTHER

Pillows containing herbs

Control PillowKapha PillowPitta PillowPlacebo PillowVata Pillow

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duquesne University

Pittsburgh, Pennsylvania, 15282, United States

Location

MeSH Terms

Conditions

Parasomnias

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Paula A. Witt-Enderby

    Duquesne University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pharmacology

Study Record Dates

First Submitted

January 23, 2024

First Posted

February 8, 2024

Study Start

February 1, 2024

Primary Completion

July 31, 2025

Study Completion

July 31, 2025

Last Updated

April 17, 2026

Record last verified: 2026-04

Locations

US(1)