Validation Study of a Modified Miniature Bruxism Detection/Analyzing Device

Objectives: Miniature sleep bruxism detection/analyzing device (BiteStrip, Pixeltown, Germany) has been modified in its measurement apparatus and analyzing algorism; however, its validity has not been evaluated. This study determined the validity of BiteStrip assessment compared to masseter electromyography (EMG) recording with polysomnography (PSG) plus audio-video recording.
Methods: Intended subjects were 17 healthy volunteers (6/11: female/male, mean age: 31.5+/-5.2yrs), and each subject underwent a standard single overnight PSG assessment (Neurofax EEG-9200, Nihon Koden) of bilateral masseter activity. Concomitantly, right side masseter activity was also assessed by BiteStrip. EMG data were collected with 200Hz sampling frequency, then applied to 60 ms[EH1] Root Mean Square process to compare the individual maximum voluntrary clenching (MVC). Masseter muscle hyperactivities were assessed by Lavigne’s SB burst and episode criteria (10% and 20% of MVC, respectively). A collaborator analyzed the masseter EMG data by using a software without knowing the BiteStrip score. Video recording was used to exclude masseter hyperactivities associated withtheir body motion. The correlation between BiteStrip score and number of muscle hyperactivities (PSG) was calculated by Spearman's rank correlation coefficient. Furthermore, sensitivity, specificity and accuracy were calculated between arbitrary cut-off levels of BiteStrip score and Rompré’s criteria (mild-to-moderate SB).

[EH1]Is it 60 miliseconds? Of 60 seconds?
Results: Among the 17 subjects, 3 were excluded because the sleep efficiencies were less than 80%. Consequently, final subjects were 14 subjects (4/10: female/male, mean age: 31.5+/-5.7yrs). Significant positive correlations were observed between BiteStrip score sand number of muscle hyperactivities with Lavigne’s 10% and 20% criteria (R²=0.60, ρ=0.78, p=0.006，R²=0.50, ρ=0.71, p=0.01, respectively). Sensitivity, specificity and accuracy between BiteStrip and Rompré’s criteria (more than two episodes/h) were, respectively, 1.00，0.88 and 0.93 in case BiteStrip’s cut-off criteria was set between score 1 to 2.
Conclusions: These results suggested that this modified miniature SB detection/analyzing device presents moderate to high validity in clinical use.