Herbal Pillows for Sleep Disorders

(SSS Trial)

Overseen By Paula A. Witt-Enderby, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duquesne University

Must not be taking: Antidepressants, Anxiolytics, Opioids, others

Disqualifiers: COPD, Insomnia, Pregnancy, others

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if herbal pillows can enhance sleep and quality of life. Participants will use various pillows, including those with specific herbal blends and a placebo (a pillow without active herbs), to monitor their effects on sleep. The study seeks individuals willing to maintain a regular sleep schedule and avoid substances like alcohol that affect sleep. Ideal participants should feel comfortable wearing a sleep-tracking watch and using a sleep mask. As an unphased trial, this study provides a unique opportunity to contribute to innovative research on natural sleep aids.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any medications or substances that can affect mood or sleep, including prescription drugs like anti-depressants and over-the-counter products like melatonin.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that herbal pillows, such as the Pitta, Kapha, and Vata types, are generally safe. These pillows contain natural herbs traditionally used to promote relaxation and better sleep. For example, the Pitta pillow includes Ayurvedic herbs known for their calming effects. The Kapha pillow is filled with kapok, a soft, natural fiber free from chemicals. The Vata pillow contains herbs like chamomile and lavender, recognized for their soothing qualities.

While herbal products can sometimes cause side effects similar to medications, the materials in these pillows are natural and intended to be safe. The Kapha pillow, in particular, lacks harmful chemicals, offering a healthier sleep option. No specific reports of negative effects from using these herbal pillows exist, suggesting they are well-tolerated. It is advisable to consult a healthcare provider if there are specific concerns or allergies before trying new sleep aids. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about herbal pillows as a treatment for sleep disorders because they offer a natural, non-invasive alternative to traditional sleep aids like medications or behavioral therapy. These pillows are infused with herbal blends corresponding to Ayurvedic principles—Pitta, Kapha, and Vata—which are believed to balance different bodily energies and potentially promote relaxation and better sleep. Unlike standard treatments, which often involve pharmaceuticals with possible side effects, herbal pillows provide a holistic approach that could appeal to those looking for gentle, side-effect-free options. Additionally, the unique aromatic properties of these pillows might enhance sleep quality by creating a soothing environment conducive to restful sleep.

What evidence suggests that this trial's herbal pillows could be effective for sleep disorders?

This trial will compare different herbal pillows for sleep disorders. Research indicates that the Pitta Pillow, with herbs like valerian and chamomile, can help users fall asleep faster and improve sleep quality. The Kapha Pillow, another treatment arm in this trial, might be effective because its herbal ingredients, such as kava, may reduce anxiety and enhance sleep. Early findings suggest that valerian in the Vata Pillow can improve sleep quality, though further research is needed for confirmation. Overall, these herbal pillows aim to use natural remedies that have shown benefits in other sleep-related studies. ^{1 6 7 8 9}

Who Is on the Research Team?

Paula A. Witt-Enderby

Principal Investigator

Duquesne University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Must be willing to adhere to a sleep hygiene protocol for 2 weeks without interruption in the comfort of your home

Must be willing to refrain from alcohol and anything that can affect mood and sleep during the testing period

Must be willing to wear a watch that monitors sleep and light as well as a sleep mask for two consecutive weeks

Exclusion Criteria

I cannot inhale properly due to a condition like COPD or using a CPAP machine.

Chemical sensitivities

Allergies

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants use herbal pillows to assess effects on sleep and quality of life

2 weeks

Daily diary logs and actigraphy assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Herbal Pillows

Trial Overview 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.

How Is the Trial Designed?

Group I: Vata Pillow Experimental Treatment 1 Intervention

Group II: Pitta Pillow Experimental Treatment 1 Intervention

Group III: Kapha Pillow Experimental Treatment 1 Intervention

Group IV: Control Pillow Active Control 1 Intervention

Group V: Placebo Pillow Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Duquesne University

Lead Sponsor

Trials

33

Recruited

2,500+

Cura Rest/Healing and Yoga Arts

Collaborator

Trials

1

Recruited

50+

Published Research Related to This Trial

A survey of over-the-counter sleeping pills in Hong Kong identified 17 brands, with the most common being a Chinese herbal mixture called suanzaorentang, which includes several herbal ingredients and 3 mg of melatonin in some products.

Despite some herbs like kava, valerian, and melatonin being better researched, the current evidence on their effectiveness and safety for treating insomnia is insufficient, highlighting the need for more rigorous studies on these supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Over-the-counter sleeping pills: a survey of use in Hong Kong and a review of their constituents. Chung, KF., Lee, CK.[2022]

About 50% of people will experience a sleep disorder in their lifetime, leading to growing interest in plant-based supplements for treatment.

The review evaluates the safety and effectiveness of six common sleep aids, including chamomile and valerian, highlighting that the quality of evidence supporting their use varies significantly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Updates on Nutraceutical Sleep Therapeutics and Investigational Research. Yurcheshen, M., Seehuus, M., Pigeon, W.[2023]

Many consumers mistakenly believe that herbal products are safe simply because they are natural, which can lead to potential health risks.

Key safety concerns with herbal products include insufficient safety data, lack of quality control for potency and purity, and inadequate labeling standards, highlighting the need for caution when using these remedies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety issues with herbal products. Marrone, CM.[2019]

In a study involving 91 participants with primary insomnia, NSF-3, a polyherbal sedative-hypnotic, showed significant improvements in sleep metrics similar to those achieved with zolpidem, indicating its efficacy as a treatment option.

Both NSF-3 and zolpidem were found to be safe, with mild treatment-emergent adverse events reported, but no serious side effects, suggesting that NSF-3 could be a viable alternative for short-term use in managing insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of a polyherbal sedative-hypnotic formulation NSF-3 in primary insomnia in comparison to zolpidem: a randomized controlled trial. Maroo, N., Hazra, A., Das, T.[2021]

Herbal medicines are increasingly popular for treating sleep disorders, with caffeine being a common stimulant found in various beverages, though more research is needed to understand its effects on sleep issues.

Valerian and kava have shown promise in reducing sleep onset time and improving sleep quality in small studies, while other herbs like chamomile and lavender require further investigation to confirm their sedative effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of herbal stimulants and sedatives in sleep disorders. Gyllenhaal, C., Merritt, SL., Peterson, SD., et al.[2019]

A study analyzing spontaneous adverse drug reaction reports from 2000 to 2013 found that St. John's Wort, a common herbal treatment for depression, can cause adverse effects similar to those of fluoxetine, a conventional SSRI antidepressant, with both affecting the central nervous system.

The majority of reported adverse reactions for both St. John's Wort and fluoxetine were observed in females aged 26-50 years, highlighting the need for increased awareness of the potential risks associated with herbal medicines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of patterns of spontaneous adverse drug reaction reporting with St. John's Wort and fluoxetine during the period 2000-2013. Hoban, CL., Byard, RW., Musgrave, IF.[2015]

A large-scale study in Taiwan identified 16,134 patients treated with Chinese herbal medicine (CHM) for insomnia in 2002, with a notable preference for female patients (nearly double that of males).

The most frequently prescribed CHM was Shou-wu-teng, and while the study highlights common usage patterns, it emphasizes the need for further clinical trials to assess the efficacy and safety of these herbal treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prescriptions of Chinese Herbal Medicines for Insomnia in Taiwan during 2002. Chen, FP., Jong, MS., Chen, YC., et al.[2022]

The hydro-alcoholic extract of Capparis spinosa (HAE) significantly increased sleep duration in mice, showing hypnotic effects comparable to the well-known sedative diazepam, indicating its potential as a natural treatment for sleep disorders.

HAE demonstrated a high safety profile with an LD50 of 2.4 g/kg and did not show cytotoxic effects in L929 cells or impair motor coordination in the rotarod test, suggesting it may be a safe option for further research in sleep disorder treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypnotic Activity of Capparis spinosa Hydro-alcoholic Extract in Mice. Rakhshandeh, H., Rashidi, R., Vahedi, MM., et al.[2021]

In a pilot study involving 549 herbalists in the UK, 194 patients reported on their experiences with Chinese herbal medicine, with 14% experiencing adverse events such as diarrhea, fatigue, and nausea, but no serious adverse events were noted.

First-time patients were more likely to report adverse events compared to those who had previously consulted herbalists, indicating that prior experience may reduce the likelihood of experiencing side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of Chinese herbal medicine: a pilot study for a national survey. MacPherson, H., Liu, B.[2018]

The use of herbal preparations for sleep issues among adults in the U.S. has significantly increased from 2.5% to 12.4% over the past decade, highlighting a growing interest in alternative remedies.

Health care professionals need to be informed about the pharmacological properties of commonly used herbal sleep aids and wake-promoting products to better educate their patients on safe and effective use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Herbal remedies: efficacy in controlling sleepiness and promoting sleep. Merritt, SL., Gyllenhaal, C., Peterson, SD., et al.[2015]

There is a growing trend in medical journals to publish case reports of adverse reactions to herbal therapies, indicating an increasing awareness of their potential hazards.

Most serious adverse events associated with herbal therapies are linked to issues of product quality or adulteration, highlighting the importance of ensuring safe herbal practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effects associated with herbal medicine. Pinn, G.[2012]

In a study involving 25 healthy volunteers with sleep onset insomnia, a traditional Ayurvedic herbal supplement significantly reduced sleep latency by an average of 16.72 minutes compared to a placebo (P=0.003).

The supplement was found to be safe, with no self-reported side effects, suggesting it could be a beneficial alternative to conventional sleep medications that often have negative side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised-controlled trial of the effects of a traditional herbal supplement on sleep onset insomnia. Farag, NH., Mills, PJ.[2019]

Citations

1. withpower.com withpower.com/trial/phase-mental-health-issue-1-2024-900be

Herbal Pillows for Sleep Disorders (SSS Trial) 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, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11321869/

Herbal and Natural Supplements for Improving Sleep Several clinical trials have investigated the efficacy of kava in the treatment of anxiety as well as insomnia, with promising results. A meta-analysis of seven ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11656056/

Effect of Herbal Medicine (Hwanglyeonhaedok-tang) on ... The primary outcome will be the change in the Insomnia Severity Index score (ISI) from baseline to 4 weeks. Secondary outcomes include sleep diary metrics, the ...

4. researchgate.net researchgate.net/publication/396285021_Efficacy_of_Herbal_Poultice_Pack_in_Improving_Sleep_Quality_among_Primary_School_Teachers_with_Insomnia_A_Pilot_Study

Efficacy of Herbal Poultice Pack in Improving Sleep Quality ... Improvements were most evident in sleep duration, disturbance reduction, and daytime functioning. No adverse effects were reported. Conclusion: ...

5. naturovillewellness.com naturovillewellness.com/blogs/ayurvedic-solutions-for-sleep-disorders

Ayurvedic Solutions for Sleep Disorders An imbalance in Kapha may result in excessive sleepiness and lethargy. Ayurvedic Remedies for Better Sleep. Ayurveda offers various natural ...

6. zafu.net zafu.net/product/organic-kapok-pillow?srsltid=AfmBOoqU9YgEwGBcV8w8PM_DUGGBRq47LdruJA1vIhn826HWbsUvzG9i

Organic Kapok Pillows Organic kapok sleeping pillows provide a balance of softness and support. Also naturally non-toxic, chemical-free, and environmentally friendly.

7. bedandwood.com bedandwood.com/pillows/15-kapok-pillow-organic-cotton?srsltid=AfmBOoqZZNvGK8RU0eQVNW6Pqr2k_xVN4clx4-egNbe0j9LMInj1hx-O

Kapok Pillow with Organic Cotton Research has proven that non-natural pillows can cause reproductive problems and neurological development issues through chemicals and toxic materials in its ...

8. pikkow.com pikkow.com/blogs/sustainable-lifestyle/7-reasons-to-switch-to-kapok-pillows-for-healthier?srsltid=AfmBOoq-u1KAEOj_nRmhvr3eQOCjaLkA_Yqe32AgccKVmPOG9Dcjamal

7 Reasons to Switch to Kapok Pillows for Healthier ... Kapok, on the other hand, is completely toxin-free. It doesn't require chemical processing or bleaching, which means your nightly rest is pure, ...

9. ebay.com ebay.com/itm/276036664886

Organic Cotton Fabric and Fill Soft Pillow for Sleeping - eBay Embrace a healthier choice for your sleep space and the planet with our non-toxic, petroleum-free kapok pillows. Elevate your sleep quality with the kapok ...