Habit Awareness Bracelet for Nail Biting

Overseen By Eden Axler, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Pregnancy, Allergies, Incompatible device, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a bracelet that vibrates gently when it detects nail-biting. It targets adults who bite their nails a lot. The vibration helps make them aware of their habit, which could help them stop.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is the Habit Awareness Bracelet safe for humans?

The Habit Awareness Bracelet, used in studies for conditions like trichotillomania (hair pulling), has been generally well-received by participants, with no major safety concerns reported. However, some users noted issues with the device's reliability and comfort. ^{1 2 3 4 5}

How is the Habit Awareness Device treatment for nail biting unique?

The Habit Awareness Device, also known as Keen2, is unique because it uses advanced thermal sensors to accurately track hand movements and provide real-time feedback, helping users become aware of and reduce nail biting, unlike traditional methods that may not offer precise monitoring or immediate feedback. ^{2 5 6 7 8}

What data supports the effectiveness of the treatment Habit Awareness Device, Keen2, HabitAware Keen2, Habit Awareness Device for nail biting?

Research on similar devices for trichotillomania (a condition involving repetitive hair pulling) shows that awareness-enhancing devices can significantly reduce unwanted behaviors by alerting users when they occur. Additionally, studies on nail-biting treatments indicate that self-monitoring and behavior modification techniques can effectively decrease nail-biting habits. ^{1 3 4 9 10}

Who Is on the Research Team?

Shari Lipner, MD, PhD

Principal Investigator

Professor of Clinical Dermatology

Are You a Good Fit for This Trial?

Adults aged 18-95 with a nail-biting problem (onychophagia) who can sign consent and follow the study schedule. They must have a compatible smartphone but cannot join if they're allergic to bracelet materials, unable to maintain a pain diary, pregnant/nursing, or planning pregnancy.

Inclusion Criteria

Must understand and voluntarily sign an informed consent form

Must be able to adhere to the study visit schedule and other protocol requirements

I have been diagnosed with chronic nail-biting.

Exclusion Criteria

Subject is sensitive or allergic to any of the elements included in this study

Subject does not have a compatible personal device with either IOS 13.0 or greater or Android version 6.0 or greater

Subject is unable to provide written informed consent for any reason

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants wear the HabitAwareness bracelet for 12 weeks, which vibrates gently when nail-biting is detected

12 weeks

Follow-up

Participants are monitored for changes in nail health and nail-biting behavior

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Habit Awareness Device

Trial Overview The trial is testing whether a vibrating bracelet can help people stop biting their nails. Participants will wear this HabitAware bracelet for 12 weeks and use an app that tracks vibrations as an indicator of nail-biting frequency.

How Is the Trial Designed?

Group I: HabitAware Participants Experimental Treatment 1 Intervention

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.

Habit Awareness Device is already approved in United States, European Union for the following indications:

Approved in United States as Keen2 for:

• Onychophagia (nail biting)

Approved in European Union as Keen2 for:

• Trichotillomania (hair pulling)
• Dermatillomania (skin picking)
• Onychophagia (nail biting)

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Published Research Related to This Trial

A pilot study involving three female participants showed that a prototype device designed to enhance awareness and monitor hair pulling behaviors significantly reduced trichotillomania symptoms during its use.

Participants reported that the device effectively increased their awareness of hair pulling behaviors and received enthusiastic acceptance, suggesting it could improve the effectiveness of habit reversal therapy for trichotillomania.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prototype awareness enhancing and monitoring device for trichotillomania. Himle, JA., Perlman, DM., Lokers, LM.[2021]

Habit Reversal Therapy (HRT) combined with an electronic Awareness Enhancing and Monitoring Device (AEMD) showed significant improvements in trichotillomania symptoms over a nine-week period in a trial with 20 participants.

While participants found the AEMD helpful for alerting them to hair-pulling behaviors, the device had reliability issues and wearability complaints, suggesting the need for design improvements to enhance its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Awareness Enhancing and Monitoring Device plus Habit Reversal in the Treatment of Trichotillomania: An Open Feasibility Trial. Himle, JA., Bybee, D., O'Donnell, LA., et al.[2020]

In a study of 21 participants over four weeks, both the bitter substance application and the competing response method significantly improved nail length, but the competing response method was more effective overall.

The competing response method not only led to better nail growth but also reduced skin damage and increased participants' perceived control over their nail-biting habit, unlike the control group that showed no significant improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating nailbiting: a comparative analysis of mild aversion and competing response therapies. Silber, KP., Haynes, CE.[2019]

The prototype wrist-worn motion detection device and accompanying mobile app for Habit Reversal Training (HRT) showed high usability and acceptability among 10 adults with trichotillomania, effectively reducing hair pulling severity over a 4-week period.

Both the device and app combination and a simpler reminder bracelet led to significant improvements in hair pulling behavior, suggesting that both methods can be effective, but further research with a larger sample is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot trial of a technology assisted treatment for trichotillomania. Stiede, JT., Woods, DW., Idnani, AK., et al.[2023]

A self-managed behavior-modification program effectively reduced problematic nail biting through self-monitoring and differential reinforcement, demonstrating its efficacy in changing habitual behaviors.

The use of a picture-comparison procedure for treatment integrity allowed for comprehensive monitoring of progress throughout the day, minimizing the need for constant oversight by a secondary observer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-administered behavior modification to reduce nail biting: incorporating simple technology to ensure treatment integrity. Craig, AR.[2021]

The Tingle wearable device, which incorporates thermal sensors, significantly improves the accuracy of tracking hand positions on the head compared to traditional wrist-worn sensors, achieving high accuracy in distinguishing behaviors from six different locations on the head in a study of 39 adult participants.

This device shows promise for clinical applications, particularly in monitoring body-focused repetitive behaviors (BFRBs) like nail biting and hair pulling, which are often misdiagnosed and undertreated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thermal sensors improve wrist-worn position tracking. Son, JJ., Clucas, JC., White, C., et al.[2020]

A new portable device for monitoring bruxism was developed and tested on 30 subjects over 3 nights, showing it is practical and user-friendly for clinical applications.

The device revealed that individuals aware of their bruxism exhibited significantly longer bruxism duration and frequency compared to those who were unaware, highlighting its effectiveness in analyzing bruxism activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a portable bruxism monitoring and analysis device equipped with a microcomputer and its practical application. Sakagami, R., Horii, T., Ino, S., et al.[2019]

In a study involving 10 participants with bruxism, a wireless biofeedback device significantly reduced the average episodes of teeth grinding from 9.8 to 3.0 times per night after six weeks of therapy, and further to 2.9 times by three months.

The duration of bruxism events also decreased from an average of 20.7 seconds to 10.0 seconds after six weeks, indicating that biofeedback therapy is an effective and convenient treatment option for managing bruxism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Preliminary study of wireless biofeedback therapy for treatment of bruxism]. Gu, WP., Yin, XM., Zhang, FM., et al.[2013]

The new semi-automatic method for analyzing the Bruxcore Bruxism-Monitoring Device (BBMD) demonstrated very high interrater reliability (ICC = 0.99), indicating that different examiners can consistently evaluate bruxism severity.

The BBMD effectively differentiated between sleep bruxers and healthy controls, achieving a sensitivity of 79.2% and a specificity of 95.2%, suggesting it is a reliable tool for clinical diagnosis of bruxism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new analyzing method for quantification of abrasion on the Bruxcore device for sleep bruxism diagnosis. Ommerborn, MA., Giraki, M., Schneider, C., et al.[2019]

The Smart Retainer® and TheraMon® microelectronic sensors effectively measure wear times in orthodontic treatments, accurately distinguishing between wear time and non-wear time based on temperature changes.

The TheraMon® sensor is more versatile than the Smart Retainer® as it can be integrated into various orthodontic appliances and provides precise documentation of wear times down to the minute.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applicative characteristics of new microelectronic sensors Smart Retainer® and TheraMon® for measuring wear time. Schott, TC., Göz, G.[2022]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Prototype awareness enhancing and monitoring device for trichotillomania. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Awareness Enhancing and Monitoring Device plus Habit Reversal in the Treatment of Trichotillomania: An Open Feasibility Trial. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Treating nailbiting: a comparative analysis of mild aversion and competing response therapies. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Pilot trial of a technology assisted treatment for trichotillomania. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Self-administered behavior modification to reduce nail biting: incorporating simple technology to ensure treatment integrity. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Thermal sensors improve wrist-worn position tracking. [2020]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Development of a portable bruxism monitoring and analysis device equipped with a microcomputer and its practical application. [2019]

8. China pubmed.ncbi.nlm.nih.gov

[Preliminary study of wireless biofeedback therapy for treatment of bruxism]. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

A new analyzing method for quantification of abrasion on the Bruxcore device for sleep bruxism diagnosis. [2019]

10. Germany pubmed.ncbi.nlm.nih.gov

Applicative characteristics of new microelectronic sensors Smart Retainer® and TheraMon® for measuring wear time. [2022]