NCT06111729

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
12mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Jan 2023May 2027

Study Start

First participant enrolled

January 24, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 26, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 1, 2023

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

4.3 years

First QC Date

October 26, 2023

Last Update Submit

April 20, 2026

Conditions

Nail Biting

Outcome Measures

Primary Outcomes (1)

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

    baseline; 4 weeks; 8 weeks; 12 weeks

Secondary Outcomes (2)

  • 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

Study Arms (1)

HabitAware Participants

EXPERIMENTAL

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

Interventions

HabitAware groupDEVICE

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.

HabitAware Participants

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Department of Dermatology

New York, New York, 10022, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 37305101BACKGROUND

MeSH Terms

Conditions

Nail Biting

Condition Hierarchy (Ancestors)

HabitsBehavior

Study Officials

  • Shari Lipner, MD, PhD

    Professor of Clinical Dermatology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eden Axler, BS

CONTACT

6469623376eda4007@med.cornell.edu

Amit Singal, BA

CONTACT

2019144096

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2023

First Posted

November 1, 2023

Study Start

January 24, 2023

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Last Updated

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

All of the individual participant data collected during the trial, after de-identification

Shared Documents
SAP, CSR
Time Frame
Immediately following publication. no end date
Access Criteria
Anyone who wishes to access the data

Locations

US(1)