Localized Body Cooling for Obesity

(Moona Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Silvana Pannain, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Chicago

Must not be taking: Melatonin, Psychoactive, Hypnotic, others

Disqualifiers: Sleep apnea, Diabetes, Neurological disorders, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this study is to see the effect that a cooling pillow pad called Moona has on sleep quality.

Will I have to stop taking my current medications?

The trial requires that you have not used melatonin, psychoactive, hypnotic, stimulant, or pain medications regularly in the past month, except occasionally. If you are taking these medications regularly, you may need to stop before participating.

How does the Moona Device treatment for obesity differ from other treatments?

The Moona Device offers a unique approach to treating obesity by using localized body cooling, which is different from traditional methods like surgery, medication, or devices that occupy space in the stomach. This method focuses on cooling specific body areas to potentially influence metabolism and fat reduction, providing a non-invasive alternative to more common treatments. ^{1 2 3 4 5}

Research Team

Silvana Pannain, MD

Principal Investigator

University of Chicago

Eligibility Criteria

This trial is for African American men and women aged 21-50 with a BMI of 27 to 45 kg/m2 who often get poor sleep (5-7 hours per night or have high PSQI scores). Participants should not have severe sleep apnea, other major sleep disorders, diabetes, neurological or psychiatric conditions, consume excessive caffeine, be pregnant/breastfeeding, or have young children that disrupt sleep.

Inclusion Criteria

My high blood pressure or cholesterol is under control.

I am between 21 and 50 years old.

Sleeping between 22:00 and 08:00

Exclusion Criteria

I have had weight loss surgery in the past.

I have been diagnosed with diabetes.

I have been diagnosed with severe sleep apnea or another sleep disorder.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Moona device to assess its effects on sleep quality and metabolism

3 weeks

Baseline and Day 22 assessments

Follow-up

Participants are monitored for changes in sleep and glucose homeostasis after treatment

4 weeks

Treatment Details

Interventions

• Moona Device (Other)

Trial Overview The study tests the Moona Device—a cooling pillow pad—against an inactive version to see if it improves sleep quality in participants. The goal is to determine whether localized body cooling at night can positively affect both rest and metabolism in individuals with overweight and obesity.

Participant Groups

Group I: Moona Active Group Active Control 1 Intervention

Participants in the Moona Active Group will placed the device between the pillow and the pillow cover, under their head and neck.

Group II: Moona Inactive Group Placebo Group 2 Interventions

Participants in the Moona Inactive Group will placed the device between the pillow and the pillow cover, under their head and neck.

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Pete Salzmann

University of Chicago

Chief Executive Officer since 2018

MD from University of Chicago’s Pritzker School of Medicine, MBA from Stanford University’s Graduate School of Business

Anh Nguyen

University of Chicago

Chief Medical Officer

MD from Rutgers New Jersey Medical School, MBA from University of Chicago

Findings from Research

The study involving 33 morbidly obese individuals showed that a 1000 cc intragastric balloon, used for six months, resulted in only a modest average weight loss of 8 kg, with many patients regaining weight after initial loss.

Significantly lower levels of the hormone Bombesin were observed after the balloon was removed, suggesting a potential hormonal response that requires further investigation, although the balloon did not effectively aid in sustained weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 1000 cc Intragastric Balloon for Weight Reduction. Lavy, A., Lachter, J., Zinder, O., et al.[2021]

Intragastric balloons and capsules are emerging as non-invasive treatments for obesity, effectively promoting weight loss by occupying stomach space, which increases feelings of fullness and reduces food intake.

These methods, including devices like ReShape and Orbera balloons, are considered safe and have advantages such as being reusable, although they may cause some gastrointestinal side effects like nausea and vomiting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Progress in the study of intragastric occupancy device for weight reduction. Yu, Q., Cao, Y., Wang, Z., et al.[2023]

In a study involving 120 participants, the acupuncture group showed a significantly higher effective rate of 76.3% for weight loss compared to 27.5% in the diet-only group.

Acupuncture not only aids in weight loss but also positively affects lipid metabolism by decreasing total cholesterol (TC), triglycerides (TG), and low-density lipoprotein cholesterol (LDL-C), while increasing high-density lipoprotein cholesterol (HDL-C).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical study on acupuncture for treatment of 80 cases of simple obesity]. Mi, YQ.[2018]

The novel full sense device (FSD) was successfully placed in all juvenile pigs, demonstrating technical feasibility and safety for treating obesity in this porcine model.

While the FSD showed potential to decrease food intake and reduce weight gain in the one pig where it was retained, a significant issue was the high migration rate of the device, with most FSDs moving to the stomach within a week.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Full Sense Device to Treat Obesity in a Porcine Model: Preliminary Results. Park, JH., Bakheet, N., Na, HK., et al.[2020]

Bariatric surgery is the most effective long-term treatment for obesity, significantly improving weight loss and reducing obesity-related health complications, especially in patients with a BMI over 40 or over 35 with related health issues.

While bariatric surgery can lead to decreased overall mortality, careful patient selection is crucial due to the potential for serious complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical treatment of obesity. Bult, MJ., van Dalen, T., Muller, AF.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

A 1000 cc Intragastric Balloon for Weight Reduction. [2021]

2. China pubmed.ncbi.nlm.nih.gov

Progress in the study of intragastric occupancy device for weight reduction. [2023]

3. China pubmed.ncbi.nlm.nih.gov

[Clinical study on acupuncture for treatment of 80 cases of simple obesity]. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

A Novel Full Sense Device to Treat Obesity in a Porcine Model: Preliminary Results. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Surgical treatment of obesity. [2022]