Habit Awareness Device for Treatment of Onychophagia

NCT ID: NCT06111729

Last Updated: 2025-05-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-24
• Study Completion Date: 2026-05-31

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.

Conditions

Nail Biting

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

HabitAware group

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shari Lipner, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor of Clinical Dermatology

Locations

Weill Cornell Department of Dermatology

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Eden Axler, BS

Role: CONTACT

eda4007@med.cornell.edu

6469623376

Amit Singal, BA

Role: CONTACT

2019144096

Facility Contacts

Shari Lipner, MD, PhD

Role: primary

shl9032@med.cornell.edu

Eden Axler, BS

Role: backup

eda4007@med.cornell.edu

References

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.

Reference Type: BACKGROUND

PMID: 37305101 (View on PubMed)

Other Identifiers

22-12025533

Identifier Type: -

Identifier Source: org_study_id