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NCT Number: NCT06111729

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.

Recruiting

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Key information

Conditions

Nail Biting Behavior Habits

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Department of Dermatology

New York, 10022, United States

Location status: Recruiting

Location contact

Eden Axler, BS

CONTACT

[email protected]

Shari Lipner, MD, PhD

CONTACT

[email protected]

Shari Lipner, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HabitAware group

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.

Primary outcomes

  1. Mean Change in Nail Biting Behavior as Measured by Number of Patient Reported Vibrations a Day

    Time frame: baseline; 4 weeks; 8 weeks; 12 weeks

Secondary outcomes

  1. Change in nail length in millimeters

    Time frame: Monthly for 3 months

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

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Amit Singal, BA

CONTACT

2019144096

Eden Axler, BS

CONTACT

[email protected]

6469623376

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Nov 1, 2023
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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