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TMJ NextGeneration(TM) Feasibility Study (Bruxoff)

Primary Purpose

Bruxism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TMJ NextGeneration(TM)
Sponsored by
TMJ Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bruxism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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;
  2. Subject has any sleep disorder other than bruxism;
  3. Subjects who have had direct trauma to the jaw;
  4. Subjects who have had prior TMJ or ear surgery;
  5. 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;
  6. Subjects with visible or congenital ear deformity as observed on targeted physical exam;
  7. Subjects whose ear canal anatomy does not allow for fit of the study device;
  8. Subjects who have a history of ear pain unrelated to TMJ;
  9. Subjects who have a history of ear drainage in the past 6 months;
  10. Subjects who have active ear drainage, swelling, or redness as observed on targeted physical exam;
  11. Subject has experienced chronic pain (not including migraine pain) associated with sleep bruxism or TMD for more than six months;
  12. Subject has a pacemaker.

Sites / Locations

  • Ear, Nose and Throat Associates of South Florida
  • Ear, Nose and Throat Associates of South Florida

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Feasibility

Arm Description

Assessing EMG activity with Bruxoff(TM) device

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 2, 2014
Last Updated
June 8, 2015
Sponsor
TMJ Health
Collaborators
Cardiox Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02257320
Brief Title
TMJ NextGeneration(TM) Feasibility Study
Acronym
Bruxoff
Official Title
A Feasibility Study of the Bruxoff™ Device to Assess EMG Activity in Subjects Diagnosed With Sleep Bruxism Using TMJ NextGeneration(TM)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TMJ Health
Collaborators
Cardiox Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The study will be conducted at one study center in the U.S. Subjects will be enrolled in the trial for a period of 8 weeks. The study will consist of a screening phase lasting up to 2 weeks and a follow up treatment period lasting 8 weeks. Subjects will visit the dental clinic twice during the screening period, then five times during the treatment period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bruxism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Feasibility
Arm Type
Other
Arm Description
Assessing EMG activity with Bruxoff(TM) device
Intervention Type
Device
Intervention Name(s)
TMJ NextGeneration(TM)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effectiveness of Bruxoff(TM) to measure EMG activity in bruxing subjects using the TMJ NextGeneration(TM) device.
Time Frame
baseline and 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
simon blackburn
Organizational Affiliation
Cardiox Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Ear, Nose and Throat Associates of South Florida
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33487
Country
United States
Facility Name
Ear, Nose and Throat Associates of South Florida
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States

12. IPD Sharing Statement

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TMJ NextGeneration(TM) Feasibility Study

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