Clinical Trial: TMJ NextGen Pilot Study to Treat Subjects With Bruxism

Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Pilot Study of the TMJ NextGeneration Compared to the DSG Relaxer for Reduction in Nocturnal Bruxism Episodes in Subjects Diagnosed With Sleep Brux

Brief Summary: The study is an open-label, prospective, multicenter, randomized, two treatment parallel, comparison study of the TMJ NextGeneration and DSG Relaxer in the reduction of nocturnal bruxism episodes in subjects diagnosed with sleep bruxism.

Detailed Summary: The study will be conducted at multiple study centers in the U.S. Subjects will be enrolled in the trial for a period of 44 days. The study will consist of a screening period lasting up to 30 days, a device fitting period of 14 days, and a treatment period lasting 30 days. Subjects will visit the clinic three times during the screening period, followed by visits at Day 1, Day 14, and Day 44 of the study. Subjects will visit the sleep center once during the screening period (Day -1) and once during the treatment period (Day 43).
Sponsor: Cardiox Corporation

Current Primary Outcome: The primary objective of this study is to determine the effectiveness of the TMJ NextGeneration to reduce nocturnal bruxism episodes in subjects experiencing sleep bruxism as determined by polysomnography. [ Time Frame: 30 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome: The secondary objective of this study is to further establish the safety of the TMJ NextGeneration device as determined by adverse events. [ Time Frame: 30 days ]

Original Secondary Outcome: Same as current

Information By: Cardiox Corporation

Dates:
Date Received: May 12, 2015
Date Started: June 2015
Date Completion: November 2015
Last Updated: May 13, 2015
Last Verified: May 2015