Obstructive Sleep Apnea Clinical Trial
Official title:
The Effect of Tooth Position During Orthodontic Treatment on the Apnea/ Hypopnea Index (AHI)
The study design of this research project involves orthodontic patients registered at the
Harvard School of Dental Medicine who are deemed eligible to undergo orthodontic treatment
and who have been provided with sufficient information to make informed consent to join the
sleep study. These patients will be provided with the Medibyte sleep monitor and instructed
on the proper manner in which it should be set up and worn for the one night study period.
This process will be carried out twice throughout the course of the study, once before any
orthodontic appliance has been cemented and once after the required amount of tooth movement
has been attained with the orthodontic appliance still in place.
The de-identified data from the Medibyte monitor will be downloaded using the Braebon
software and analyzed.
The study design of this research project involves recruiting orthodontic patients registered
at the Harvard School of Dental Medicine who are deemed eligible to undergo orthodontic
treatment and who have been provided with sufficient information to make informed consent to
join the sleep study. The participants will be provided with the Medibyte sleep monitor and
instructed on the proper manner in which it should be set up and worn for the one or two
night study period. The purpose of the Medibyte monitor is solely to provide a calibrated
value of AHI. The Medibyte monitor will not be utilized for investigations and/or treat,
cure, mitigate a medical condition. This process will be carried out twice throughout the
course of the study, once before any orthodontic appliance has been cemented and once after
the required amount of tooth movement has been attained with the orthodontic appliance still
in place.
The de-identified data from the Medibyte monitor will be downloaded using the Braebon
software and analyzed providing a baseline value and post orthodontic movement AHI value.
Additionally the patients arch width, length and other orthodontic measurements will also be
taken both from their 3-D dental models and also their 2-D lateral cephalogram x-ray all of
which are part of the routine orthodontic records (the x-rays will be taken regardless of the
patients participation in the study since they are a required component of the orthodontic
records taken at HSDM). The values obtained from the patients casts, lateral cephalogram and
Medibyte AHI values will be analyzed both pre-orthodontic appliance cementation and also post
tooth movement. The changes, if any, in the dental parameters as compared with the AHI values
will allow the investigation of the orthodontic effects of expanding the maxilla, moving the
front teeth either forwards or backwards which in effect cause changes to the airway and its
effect on AHI values during sleep. In addition to the measurements taken intra-orally,
surveys will also be undertaken to study any changes the patients may experience in their
sleep and quality of life. If the Medibyte shows a severe reading for obstructive sleep
apnea, these patients will then be referred to a sleep specialist for further more conclusive
testing.
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