Nail Biting
Conditions
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.
Interventions
DEVICEHabitAware 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.
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
CONTACTEden Axler, BS
CONTACTAmit Singal, BA
PRINCIPAL_INVESTIGATORShari Lipner, MD, PhD
Professor of Clinical Dermatology
Outcome results
None listed