Habit Awareness Device for Treatment of Onychophagia

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.

Study Overview

• Status: Recruiting
• Conditions: Nail Biting
• Intervention / Treatment: Device: HabitAware group

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eden Axler, BS; Phone Number: 6469623376; Email: eda4007@med.cornell.edu
• Study Contact Backup: Name: Amit Singal, BA; Phone Number: 2019144096

Study Locations

• United States
  • New York
    • New York, New York, United States, 10022
      • Recruiting
      • Weill Cornell Department of Dermatology
      • Contact: Shari Lipner, MD, PhD; Email: shl9032@med.cornell.edu
      • Contact: Eden Axler, BS; Email: eda4007@med.cornell.edu
      • Principal Investigator: Shari Lipner, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HabitAware Participants; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Shari Lipner, MD, PhD, Professor of Clinical Dermatology

Publications and helpful links

General Publications

• Stiede JT, Woods DW, Idnani AK, Pritchard J, Klobe K, Kumar S. Pilot trial of a technology assisted treatment for trichotillomania. J Obsessive Compuls Relat Disord. 2022 Apr;33:100726. doi: 10.1016/j.jocrd.2022.100726. Epub 2022 Apr 29.

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2023
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: October 26, 2023
• First Submitted That Met QC Criteria: October 26, 2023
• First Posted (Actual): November 1, 2023

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Habits; Nail Biting
• Other Study ID Numbers: 22-12025533

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after de-identification
• IPD Sharing Time Frame: Immediately following publication. no end date
• IPD Sharing Access Criteria: Anyone who wishes to access the data
• IPD Sharing Supporting Information Type: SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes