Habit Awareness Device for Treatment of Onychophagia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HabitAware group.
- Who it may be relevant to
- Registry conditions: Nail Biting. Basic parameters: 18 years — 95 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
- 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.
Primary outcome measures
- 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 outcome measures (2)
- Change in nail length in millimeters [Time frame: Monthly for 3 months]
- Change in nail health as measured by Malone-Massler Scale For Nail Biting [Time frame: baseline; 3 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Weill Cornell Department of Dermatology — New York
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. PMID 37305101
Identifiers
NCT: NCT06111729 · 22-12025533