Status:
COMPLETED
TMJ NextGeneration(TM) Feasibility Study
Lead Sponsor:
TMJ Health
Collaborating Sponsors:
Cardiox Corporation
Conditions:
Bruxism
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 foll...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02257320
Start Date
November 1 2014
End Date
May 1 2015
Last Update
June 10 2015
Active Locations (2)
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1
Ear, Nose and Throat Associates of South Florida
Boca Raton, Florida, United States, 33487
2
Ear, Nose and Throat Associates of South Florida
Boynton Beach, Florida, United States, 33426