Habit Awareness Device for Treatment of Onychophagia

Study Overview
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Brief Summary
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This clinical trial wants to find out if using a special bracelet that vibrates gently whenever someone with a nail-biting problem bites their nails can help them stop. The investigators are looking at adults who bite their nails a lot. If this bracelet works, it could make nail-biters bite their nails less and have a better life. The main question the investigators are trying to answer is: Does the gentle vibration from the bracelet make people bite their nails less? The investigators will give participants a bracelet that vibrates when it senses nail-biting for 12 weeks. Participants will need to download an app that connects to the bracelet. This app will help the investigators keep track of how often participants get these vibration signals and see if nail-biting decreases while using the bracelet.

Official Title
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Habit Awareness Device for Treatment of Onychophagia

Conditions
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Nail Biting

Intervention / Treatment
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* Device: HabitAware group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed with onychophagia Must understand and voluntarily sign an informed consent form Must be aged 18-95 years at the time of consent Must be able to adhere to the study visit schedule and other protocol requirements Exclusion Criteria: Subject is unable to provide written informed consent for any reason. Subject is sensitive or allergic to any of the elements included in this study. Subject is unable to complete the required pain dairy. Subject is pregnant, planning pregnancy, or nursing. Subject does not have a compatible personal device with either IOS 13.0 or greater or Android version 6.0 or greater.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HabitAware Participants<br>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. | Device: HabitAware group<br>* A device that provides gentle vibration when the motion of nail biting is sensed will be provided to all participants. Participants will use an app that connects to the device to track the frequency of their nail biting over the study period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Nail Biting Behavior as Measured by Number of Patient Reported Vibrations a Day |  | baseline; 4 weeks; 8 weeks; 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in nail length in millimeters |  | Monthly for 3 months | 
| Change in nail health as measured by Malone-Massler Scale For Nail Biting | The lowest score is 0 meaning nails not bitten, free margin intact; the highest score is 3+ meaniing nails are severely bitten, fingernails bitten beyond free edge; nail margin below soft tissue border | baseline; 3 months |