Habit Awareness Device for Treatment of Onychophagia

Not Applicable

Recruiting

• Conditions: Nail Biting
• Interventions: Device: HabitAware group

• Registration Number: NCT06111729
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-24
• Study First Submitted: 2023-10-26
• Study First Submitted QC: 2023-10-26
• Study First Posted: 2023-11-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-20
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Patients diagnosed with onychophagia
2. Must understand and voluntarily sign an informed consent form
3. Must be aged 18-95 years at the time of consent
4. Must be able to adhere to the study visit schedule and other protocol requirements

Exclusion Criteria

1. Subject is unable to provide written informed consent for any reason.
2. Subject is sensitive or allergic to any of the elements included in this study.
3. Subject is unable to complete the required pain dairy.
4. Subject is pregnant, planning pregnancy, or nursing.
5. Subject does not have a compatible personal device with either IOS 13.0 or greater or Android version 6.0 or greater.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HabitAware Participants	HabitAware group	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change in nail length in millimeters	Monthly for 3 months
Change in nail health as measured by Malone-Massler Scale For Nail Biting	baseline; 3 months	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

Trial Locations

Locations (1)

Weill Cornell Department of Dermatology; 🇺🇸 New York, New York, United States