SleepGuard Biofeedback Headband Clinical Trial Summary

The first round of clinical trials for the SleepGuard biofeedback headband were completed on October 10, 2010. There were 92 patients in the trial.  The total clenching time recorded by the SleepGuard biofeedback headband each night was logged on a daily basis.  The first three days of data for each participant are baseline data.  The remaining 27 days of data are data taken with the biofeedback turned on.  Running the data through a statistical analysis package yielded a p value for the data of 0.0000000000000002 (apparently the best of any bruxism clinical trial in history).  

One illuminating way to view the data is to divide the clinical trial patients into four groups (quartiles), ranked by overall end reduction in bruxism.  The four quartiles below are ordered by bruxism reduction, where the first quartile presented had the most reduction in average nightly clenching time from the beginning of the trial to the end, and the last quartile presented had the least reduction in average nightly clenching time from the beginning of the trial to the end.  Average nightly reduction in bruxism time was measured as the difference between the normalized average nightly clenching time during the three days of initial baseline measurement (this average was normalized to 1 for all patients), and the normalized average nightly clenching time during the last three days of the trial.

These patients got an average initial reduction in bruxism time of 80% in one day after turning on the biofeedback, and by the end of the month they had a bruxism reduction of 90%.  Also taking into account the probable average reduction of clenching force of 50% to 90%, and that's a probable 95% to 99% reduction in nightly damage.  Most patients in this quartile report substantial reduction or complete elimination of pain such as jaw pain, migraines, TMJ pain, etc..

The next best performing quartile (23 patients) is shown below.

These patients' "remaining bruxism" is about twice the top group, but still very low.

As can be seen in both of the upper quartiles above, nightly clenching time was trending down steadily toward the end of the month, perhaps indicating that these patients are on the average training themselves out of their bruxism habit.  This theory is supported by anecdotal evidence in follow-up interviews several months later, where a number of patients said that after using the biofeedback for between two and four months, they were able to go for long periods (over a month) without using the headband before any daily pain returned.

Most patients in this second quartile, like the first quartile, report substantial reduction or complete elimination of pain such as jaw pain, migraines, TMJ pain, etc..

The average of the data from the lower mid quartile (23 patients) is shown below.

These patients experience approximately a 60% initial reduction in nightly clenching time when the biofeedback is turned on, and their nightly clenching times remain at roughly this level for the rest of the month.  In addition to the reduction in clenching time, it is estimated that this group experiences an reduction in clenching force of about 50%. 

There is no obvious trending downward toward the end of the month for this group, so there is no evidence that they are training themselves out of their bruxism habit, but continued use of the biofeedback appears to be a viable tool in ongoing mitigation of bruxism damage and pain.  Some patients in this quartile reported a complete elimination of pain symptoms, including TMJ pain and migraines.

The data from the worst-performing quartile (excluding one outlier, whose data is included in the whole group average, but whose data is so wacky it warps the performance of the quartile significantly) is shown below.

These patients respond well to the biofeedback at first, and then over time, their nightly bruxism times came back to a level close to their baseline levels. 

One way to interpret why this may happen is that each person may be thought of as being of "two minds".  One part of the mind wants to learn to relax and get out of the bruxism habit.  This part of the mind hears the biofeedback tone as a caring reminder about something important.

The other part of the mind wants to learn to ignore any sound heard during sleep.  For this group, this second part of the mind appears to win out, and patients return to near-baseline levels of clenching (though there is some reduction in clenching time and some  reduction in clenching force, so they still benefit).

A follow-on study is under way with the majority of patients in the lower quartile.  In the follow-on study, the biofeedback headbands given to these patients have been equipped with earphones which enable the biofeedback sound to be adjusted to a significantly louder level.  The theory here is that when the sound is louder, the part of the mind that wants to sleep through everything will have less chance to succeed, and the part of the mind that wants to respond by learning to relax rather than clench will have more chance to succeed.  Initial results of this follow-on study indicate that with a louder biofeedback sound, the majority of patients in the last quartile move into one of the first three quartiles.

As can be seen by comparing the "overall average" graph above to the four quartile graphs, the overall average is only representative of a small percentage of people in the trial.  The behavior of the quartiles is far more telling.

In conclusion, this clinical trial shows that about 75 percent of patients are able to reduce their nightly clenching substantially through ongoing use of the SleepGuard biofeedback headband.  On the average, the bulk of the benefit in nightly clenching time reduction is realized from the day the biofeedback is turned on.  Reduction in pain or elimination of pain usually follows within several days.  About 25% of patients appear to remain at the initially-reduced level ongoingly, and there are indications that about 50% of patients are able to continue to steadily reduce their nightly clenching times beyond the initial reduction.

Next Steps - Partners Wanted

Holistic Technologies is interested to partner with professionals, including Doctors, Dentists, Chiropractors, and Physical Therapists to learn even more from this clinical trial (through patient interviews), and publish journal articles based on this trial and future work. Please contact us if such a partnership would be of interest to you.