Sleep DisturbanceSSSNCT06247696
Sweet Scents to Sweet Dreams
A study testing Herbal Pillows in people with Sleep Disturbance and Mental Health Issue, run by Duquesne University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sleep Disturbance, Mental Health Issue
- What is being tested?
- Herbal Pillows
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sweet Scents to Sweet Dreams: Use of Herbal Pillows to Facilitate Sleep and Improve Quality of Life
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
- Being tested
- Herbal Pillows
- Medical subject headings
- Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herbal PillowsOther
Pillows containing herbs
| Study group | Role | What they receive |
|---|---|---|
| Placebo Pillow | Placebo comparator | Not described Receives: Other: Herbal Pillows |
| Control Pillow | Active comparator | Not described Receives: Other: Herbal Pillows |
| Vata Pillow | Experimental | Not described Receives: Other: Herbal Pillows |
| Pitta Pillow | Experimental | Not described Receives: Other: Herbal Pillows |
| Kapha Pillow | Experimental | Not described Receives: Other: Herbal Pillows |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Function
Assessments of rest/activity rhythms by wrist actigraphy
Measured: 2 weeks
Secondary outcomes (6)
Subject-reported effects on sleep
Assessments will be made using the validated sleep questionnaire, Pittsburgh Sleep Quality Index, PSQI
Measured: 2 weeks
Subject-reported effects on depression
Assessments will be made using the validated depression questionnaire, Center for Epidemiology Studies-Depression, CES-D
Measured: 2 weeks
Subject-reported effects on anxiety
Assessments will be made using the validated anxiety questionnaire, Spielberg State-Trait Anxiety Inventory, STAI
Measured: 2 weeks
Subject-reported effects on stress
Assessments will be made using the validated stress questionnaire, Perceived Stress Scale, PSS
Measured: 2 weeks
Subject-reported effects on quality of life
Assessments will be made using the validated health-related quality of life questionnaire, quality of life (Health-related Quality of Life, HR-QOL
Measured: 2 weeks
Ayurvedic assessments of doshas
Assessment of dosha-specific herbal pillows on dosha balancing
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start1 Feb 2024
- Primary completion31 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duquesne University
- Sponsor type
- University, hospital or other
- Collaborators
- Cura Rest/Healing and Yoga Arts
- Responsible party
- Principal investigator, Paula Witt-Enderby, Duquesne University
- Investigators
- Paula A. Witt-Enderby, Principal investigator, Duquesne University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247696
- Sponsor's protocol ID
- 2023/11/25
- Acronym
- SSS
- Status last verified
- Apr 2026
- First submitted
- 23 Jan 2024
- Last updated
- 17 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Available upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sweet Scents to Sweet Dreams: Use of Herbal Pillows to Facilitate Sleep and Improve Quality of Life
- ClinicalTrials.gov ID
- NCT06247696
- Acronym / sponsor ID
- SSS / 2023/11/25
- Conditions
- Sleep Disturbance, Mental Health Issue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Duquesne UniversityUniversity, hospital or other
- Collaborators
- Cura Rest/Healing and Yoga Arts
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Herbal PillowsPillows containing herbs | Other | Control Pillow, Kapha Pillow, Pitta Pillow, Placebo Pillow, Vata Pillow |
Primary outcome
Sleep Function
Time frame: 2 weeks
Assessments of rest/activity rhythms by wrist actigraphy
6 secondary outcomes
Subject-reported effects on sleep
Time frame: 2 weeks
Subject-reported effects on depression
Time frame: 2 weeks
Subject-reported effects on anxiety
Time frame: 2 weeks
Subject-reported effects on stress
Time frame: 2 weeks
Subject-reported effects on quality of life
Time frame: 2 weeks
Ayurvedic assessments of doshas
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Individual participant dataSharing planned: Undecided. Available upon reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paula A. Witt-Enderby principal investigator
Duquesne University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Herbal Pillows in people with Sleep Disturbance and Mental Health Issue, run by Duquesne University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Function (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.