Nail BitingNCT06111729
Habit Awareness Device for Treatment of Onychophagia
A study testing HabitAware group in people with Nail Biting, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Nail Biting
- What is being tested?
- HabitAware group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2023to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Amit Singal, BA contact
United States1 site, 1 recruiting
- Recruiting
Weill Cornell Department of Dermatology
New York, New York, 10022
Shari Lipner, MD, PhD, shl9032@med.cornell.edu
Eden Axler, BS, eda4007@med.cornell.edu
About this study
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
- Being tested
- HabitAware group
- Medical subject headings
- Nail Biting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: HabitAware group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Nail Biting Behavior as Measured by Number of Patient Reported Vibrations a Day
Measured: baseline; 4 weeks; 8 weeks; 12 weeks
Secondary outcomes (2)
Change in nail length in millimeters
Measured: Monthly for 3 months
Change in nail health as measured by Malone-Massler Scale For Nail Biting
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
Measured: baseline; 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start24 Jan 2023
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nail BitingStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shari Lipner, MD, PhD, Principal investigator, Professor of Clinical Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06111729
- Sponsor's protocol ID
- 22-12025533
- Status last verified
- Apr 2026
- First submitted
- 26 Oct 2023
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after de-identification
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.
PubMed 37305101
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Habit Awareness Device for Treatment of Onychophagia
- ClinicalTrials.gov ID
- NCT06111729
- Acronym / sponsor ID
- 22-12025533
- Conditions
- Nail Biting
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 24 Jan 2023 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 1 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HabitAware Participants | Experimental | Device: HabitAware groupPatients 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. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HabitAware groupA 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. | Device | HabitAware Participants |
Primary outcome
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
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Background: PubMed 37305101Stiede 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.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after de-identification
Related trials for Nail Biting
Recruiting
Mindfulness Intervention for Psychological and Family Dynamics in Children With Body-Focused Repetitive Behaviors
Mindfulness Skills, Psychosocial Education
Not yet recruitingObservational study
Effect of Nail Biting Habit on Mandibular Bone Structure: A Retrospective Radiological Study
Onychophagia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amit Singal, BA contact
Shari Lipner, MD, PhD principal investigator
Professor of Clinical Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HabitAware group in people with Nail Biting, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eden Axler, BS (6469623376, eda4007@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06111729, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.