A Randomized Controlled Study Evaluating the Safety and Effectiveness of the Fuzzle Intraoral Device for Weight Management
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Percent Total Body Weight Loss (%TBWL) at 16 Weeks
研究概览
简要总结
This study is evaluating whether the Fuzzle intraoral device can help adults with obesity lose weight when used alongside standard lifestyle counseling.
Participants in this study will receive guidance on diet and behavior to support weight loss. Some participants will also receive the Fuzzle device, a custom-made removable oral appliance worn during the day.
The study will compare weight loss outcomes between participants who use the Fuzzle device and those who follow lifestyle counseling alone over a 16-week period.
Researchers will also explore whether use of the device increases the number of participants who achieve meaningful weight loss and may evaluate changes in selected metabolic markers in a subset of participants.
详细描述
The purpose of this study is to evaluate the effectiveness of the Fuzzle intraoral device as an adjunct to standardized lifestyle counseling for weight management in adults with obesity (BMI ≥30 kg/m², ages 18-65).
This randomized, controlled study compares participants receiving the Fuzzle device in combination with standardized lifestyle counseling to those receiving lifestyle counseling alone over a 16-week period.
The primary objective is to assess whether use of the Fuzzle device results in greater percent total body weight loss at 16 weeks compared to standardized lifestyle counseling alone.
All participants receive standardized dietary and behavioral counseling, including caloric targets based on estimated energy expenditure and structured adherence support with regular follow-up. This design is intended to isolate the effect of the device as an adjunctive intervention to a controlled behavioral baseline.
The Fuzzle intraoral device is a custom-fabricated, removable oral appliance designed for daytime wear. It is intended to modulate oral sensory input within the stomatognathic system to influence eating-related behaviors, including reductions in snacking frequency and alterations in meal patterns. The device is non-invasive, reversible, and used in a home setting under provider supervision.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-65 years
- •Body mass index (BMI) ≥30 kg/m² at screening
- •Willing and able to provide informed consent
- •Willing to comply with study visits and procedures
- •Willing to participate in standardized lifestyle counseling
排除标准
- •Participation in another weight-loss clinical study within 90 days
- •Pregnancy, breastfeeding, or intent to become pregnant during the study period
- •History of eating disorders or uncontrolled psychiatric illness
- •Oral or dental conditions preventing safe device use
- •Current use of prescription or over-the-counter weight-loss medications
- •A1C >8.0% at screening (glycemic subset exclusion only)
- •Unstable diabetes medication regimen (glycemic subset exclusion only)
- •Any medical condition that, in the investigator's judgment, would interfere with safe participation
研究组 & 干预措施
Control group not to receive Fuzzle intraoral device.
Participants receive standardized lifestyle management including dietary guidance, caloric targets based on estimated energy expenditure, and structured behavioral counseling. Participants track food intake using a mobile application with weekly check-ins to reinforce adherence.
干预措施: Lifestyle Management (Behavioral)
Investigational group to receive Fuzzle intraoral device
Participants receive the Fuzzle intraoral device in addition to standardized lifestyle management as described in the control arm. Participants are instructed to wear the device during waking hours, excluding meals and oral hygiene.
干预措施: Fuzzle Intraoral Device (Device)
Investigational group to receive Fuzzle intraoral device
Participants receive the Fuzzle intraoral device in addition to standardized lifestyle management as described in the control arm. Participants are instructed to wear the device during waking hours, excluding meals and oral hygiene.
干预措施: Lifestyle Management (Behavioral)
结局指标
主要结局
Percent Total Body Weight Loss (%TBWL) at 16 Weeks
时间窗: From study enrollment to completion at 16 weeks
Percent total body weight loss (%TBWL) will be compared between study arms at Week 16. %TBWL is calculated as \[(baseline body weight - Week 16 body weight) ÷ baseline body weight\] × 100, where higher values indicate greater weight loss. Body weight will be measured using standardized procedures during in-person clinic visits.
次要结局
- Change in Body Mass Index (BMI)(From study enrollment to completion at 16 weeks)
- Proportion of Participants Achieving ≥5% Total Body Weight Loss(Baseline to Week 16)
- Change in Waist Circumference(Baseline to Week 16)
- Change in Weight-Related Quality of Life (IWQOL-Lite-CT)(Baseline to Week 16)
- Device Tolerability(Baseline to Week 16)
- Device Tolerability Assessed by Oral Comfort Visual Analog Scale (VAS), Adverse Event Incidence, and Device Adherence Metrics(Baseline to Week 16)
- Exploratory Change in High-Sensitivity C-Reactive Protein (hsCRP)(Baseline to Week 16)
- Exploratory Change in Alanine Aminotransferase (ALT)(Baseline to Week 16)