NCT02257320

Brief Summary

The study is an open-label, prospective, single-center, non-randomized feasibility study of the Bruxoff(TM) device to identify EMG activity associated with bruxism, and to assess the impact of the TMJ NextGeneration(TM) device upon the occurrence of night-time bruxism events and incidence of migraines and headache in subjects diagnosed with sleep bruxism.

Trial Health

87
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
Completed

Started Nov 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 6, 2014

Completed
26 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

June 10, 2015

Status Verified

June 1, 2015

Enrollment Period

3 months

First QC Date

October 2, 2014

Last Update Submit

June 8, 2015

Conditions

Bruxism

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of Bruxoff(TM) to measure EMG activity in bruxing subjects using the TMJ NextGeneration(TM) device.

    baseline and 8 weeks

Study Arms (1)

Feasibility

OTHER

Assessing EMG activity with Bruxoff(TM) device

Device: TMJ NextGeneration(TM)

Interventions

TMJ NextGeneration(TM)DEVICE

The TMJ NextGeneration(TM) device consists of a pair of small, hollow ear inserts. These ear inserts are custom-fit to each subject's ear canals. The devices rest in the outer third of the ear canal and have a small retraction post that allows for removal of the device from the ear. The devices conform to the shape of the ear canal when the jaw is in the open position and permit full passage of sound into each ear. The mechanisms of action of the inserts are to support the TMJ and associated secondary musculature to reduce strain in the TMJ area and to provide cognitive awareness to the wearer regarding para-functional habits, i.e., jaw clenching.

Feasibility

Eligibility Criteria

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

You may qualify if:

  • Subjects at least 18 years of age;
  • Subject has had a diagnosis of sleep bruxism;
  • Subject has been medically screened and diagnosed by a physician as having headaches and/or migraines;
  • Subject is willing to comply with the usage instructions for the Bruxoff device;
  • Is able to read and understand the ICF and has voluntarily provided written informed consent.
  • Subject is able to open their mouth at least 17 mm to be fitted for the TMJ NextGenerationTM device;
  • Male Subjects are willing to have a clean shaven face on the nights that the Bruxoff device will be used;
  • Subject agrees that when using the Bruxoff device to keep their cellular phone in another room.

You may not qualify if:

  • Subjects with any physical or behavioral disorder, which, in the opinion of the Principal Investigator, may interfere with the use of the device or compliance with the study protocol;
  • Subject has any sleep disorder other than bruxism;
  • Subjects who have had direct trauma to the jaw;
  • Subjects who have had prior TMJ or ear surgery;
  • Subjects who have a narrow ear canal or impression of the ear canal, which is prolapsed due to an anatomical shift or failure of the ear canal wall structure, or a canal that does not allow for the ear canal second turn to be identified;
  • Subjects with visible or congenital ear deformity as observed on targeted physical exam;
  • Subjects whose ear canal anatomy does not allow for fit of the study device;
  • Subjects who have a history of ear pain unrelated to TMJ;
  • Subjects who have a history of ear drainage in the past 6 months;
  • Subjects who have active ear drainage, swelling, or redness as observed on targeted physical exam;
  • Subject has experienced chronic pain (not including migraine pain) associated with sleep bruxism or TMD for more than six months;
  • Subject has a pacemaker.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ear, Nose and Throat Associates of South Florida

Boca Raton, Florida, 33487, United States

Location

Ear, Nose and Throat Associates of South Florida

Boynton Beach, Florida, 33426, United States

Location

MeSH Terms

Conditions

Bruxism

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesHabitsBehavior

Study Officials

  • simon blackburn

    Cardiox Corporation

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

October 2, 2014

First Posted

October 6, 2014

Study Start

November 1, 2014

Primary Completion

February 1, 2015

Study Completion

May 1, 2015

Last Updated

June 10, 2015

Record last verified: 2015-06

Locations

US(2)