What side effects are associated with this type of intervention?

Behavioral feedback methods, such as the vibrating bracelet being studied for nail biting, generally have minimal side effects. The primary side effects reported are related to the physical sensation of the device, such as mild discomfort or irritation from wearing the bracelet. Other common treatments for nail biting, like habit reversal training and cognitive-behavioral therapy, typically do not have significant side effects but may cause temporary emotional discomfort as individuals confront and modify their behaviors.

What prior FDA approvals exist?

There is no specific mention of prior FDA approvals for the treatment of nail biting in the provided context. The trial studying the vibrating bracelet represents a behavioral feedback mechanism aimed at reducing nail-biting behavior. Behavioral feedback devices, such as the vibrating bracelet, work by providing immediate sensory feedback to the user when the unwanted behavior occurs, helping to increase awareness and reduce the frequency of the behavior over time.

What other types of research exist?

Promising alternatives to the vibrating bracelet for nail-biting patients in 2024 include: 1) Closed-loop neurostimulation systems that provide real-time feedback based on neurochemical and electrophysiological measurements, 2) Wearable devices with advanced sensors and feedback mechanisms, such as smart rings or patches, 3) Mobile apps with AI-driven behavioral tracking and personalized intervention plans, and 4) Cognitive Behavioral Therapy (CBT) delivered through virtual reality (VR) platforms for immersive habit-reversal training.

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Behavioural Intervention

Habit Awareness Bracelet for Nail Biting

N/A

Recruiting

Led By Shari Lipner, MD, PhD

Research Sponsored by Weill Medical College of Cornell University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline; 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a bracelet that vibrates gently when it detects nail-biting. It targets adults who bite their nails a lot. The vibration helps make them aware of their habit, which could help them stop.

Who is the study for?

Adults aged 18-95 with a nail-biting problem (onychophagia) who can sign consent and follow the study schedule. They must have a compatible smartphone but cannot join if they're allergic to bracelet materials, unable to maintain a pain diary, pregnant/nursing, or planning pregnancy.

What is being tested?

The trial is testing whether a vibrating bracelet can help people stop biting their nails. Participants will wear this HabitAware bracelet for 12 weeks and use an app that tracks vibrations as an indicator of nail-biting frequency.

What are the potential side effects?

There may be minimal side effects from wearing the bracelet; however, specific side effects are not detailed in the provided information.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline; 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline; 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change in nail health as measured by Malone-Massler Scale For Nail Biting

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: HabitAware ParticipantsExperimental Treatment1 Intervention

Patients will be asked to wear the HabitAwareness bracelet for 12 weeks. The bracelet provides the attention stimulus of gentle vibration when the motion of nail biting is sensed.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The vibrating bracelet used for treating nail-biting works through behavioral feedback, a mechanism where the bracelet detects nail-biting actions and responds with a gentle vibration. This immediate feedback helps increase the patient's awareness of their nail-biting habit, allowing them to consciously interrupt and eventually reduce the behavior. This method is significant for nail-biting patients as it provides a non-invasive, real-time intervention that can be easily integrated into daily life, promoting better habit control and improving overall quality of life.

A more efficient biofeedback procedure for the treatment of nocturnal bruxism.Getting the word out: cognitive-behavioral therapy for trichotillomania (hair-pulling disorder) and excoriation (skin-picking) disorder.Nonpharmacological therapies for trichotillomania.

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Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor

1,082 Previous Clinical Trials

1,138,189 Total Patients Enrolled

Shari Lipner, MD, PhDPrincipal InvestigatorProfessor of Clinical Dermatology

4 Previous Clinical Trials

93 Total Patients Enrolled

~2 spots leftby May 2025

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