Localized Body Cooling for Obesity

(Moona Trial)

Overseen By Erin Hanlon, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

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

Disqualifiers: Sleep apnea, Diabetes, Neurological disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 22

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a cooling pillow pad called Moona to determine its effect on sleep quality. Participants will use either an active or inactive version of the device under their head and neck while sleeping. The trial seeks African American men and women who experience short or poor sleep and have a BMI between 27 and 45. Participants should not have a history of sleep disorders like sleep apnea or conditions such as diabetes. As an unphased trial, this study allows participants to contribute to innovative sleep research and potentially enhance their 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.

What prior data suggests that the Moona Device is safe for use?

Research has shown that cooling technology, such as the Moona device, is generally safe and well-tolerated. One study on similar cooling wear found significant weight loss without serious side effects, suggesting these methods are safe to use. The Moona device, used in this trial, is placed under the pillow to help improve sleep. Although specific safety data on the Moona device is limited, the absence of negative reports from similar devices is encouraging. This trial is labeled as "Not Applicable" in phase, indicating a focus on gathering initial information about effects rather than testing safety. This often suggests that the treatment is expected to be safe based on existing knowledge. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Moona Device because it offers a unique approach to managing obesity through localized body cooling. Unlike traditional weight management options like diet, exercise, or medications that focus on altering metabolism or appetite, the Moona Device uses a cooling mechanism placed under the head and neck to potentially influence body temperature regulation and fat metabolism. This method could provide a non-invasive, convenient, and drug-free alternative, making it an innovative addition to the current treatment landscape for obesity.

What evidence suggests that the Moona Device is effective for improving sleep quality?

Research has shown that thermoregulated pillows like the Moona Device can improve sleep quality. In past studies, the Moona Device helped people who are overweight or obese sleep better. This improvement likely occurs because the device cools the head and neck, regulating body temperature at night. Better sleep can lead to various health benefits, including possibly aiding weight management, although the device's direct effect on obesity remains unproven. In this trial, participants will join either the Moona Active Group or the Moona Inactive Group to evaluate the device's effectiveness. The Moona Device is expected to enhance sleep, which might indirectly support weight loss efforts. ^{1 2 3 6 7}

Who Is on the Research Team?

Silvana Pannain, MD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

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.

BMI ≥ 27 to 45 kg/m2

Exclusion Criteria

I have had weight loss surgery in the past.

History of cognitive or other neurological disorders

History of major psychiatric disorder based on DSM-V criteria

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Moona Device

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/phase-obesity-5-2023-41f39

Localized Body Cooling for Obesity (Moona Trial) 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 ...

2. trialstoday.org trialstoday.org/trial/NCT05849181

Localized Body Cooling Technology on Sleep and ... Purpose. The goal of this study is to see the effect that a cooling pillow pad called Moona has on sleep quality. Condition. Overweight ...

3. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK279038/

Pharmacologic Treatment of Overweight and Obesity in Adults The average efficacy in these studies ranges from 5-23% total body weight loss. However, as with any medical therapy, significant inter- ...

4. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials?keyword=%22Overweight%20or%20Obesity%22

San Mateo Clinical Trials To assess the efficacy of HRS9531 injection compared with placebo in weight reduction in overweight or obese subjects after 36 weeks of treatment. Multicenter ...

5. researchgate.net researchgate.net/publication/367602252_Enhanced_sleep_from_using_a_thermoregulated_pillow_real-life_data_from_MOONA_device

Enhanced sleep from using a thermoregulated pillow Enhanced sleep from using a thermoregulated pillow: real-life data from MOONA device ... Improving sleep of overweight and obese patients ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12031720/

Obesity: pathophysiology and therapeutic interventions - PMC This review aims to elucidate the pathophysiological mechanisms underlying obesity, analyze its major complications—including type 2 diabetes ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9340944/

Non-invasive cooling wear as an effective means of ... The participants achieved a significant total weight loss of 0.7 kg (0.9%), and significant reductions in BMI (0.2 kg/m2) and abdominal ...