Evaluating Instrumentation for Dental Devices Used in Treating Sleep Apnea
| Status: | Completed |
|---|---|
| Conditions: | Insomnia Sleep Studies, Pulmonary, Pulmonary |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 21 - 65 |
| Updated: | 5/3/2014 |
| Start Date: | November 2013 |
| End Date: | March 2014 |
| Contact: | Glen P Greenough, MD |
| Email: | glen.p.greenough@hitchcock.org |
| Phone: | 6036503630 |
Phase One Study Evalauting Instrumentation for Dental Devices Used in Treating Sleep Apnea
Oral appliances are an accepted means to treat obstructive sleep apnea. We propose to
develop monitoring sensors that could be inserted into commercially avaialble oral
appliances in order to monitor effectiveness of the oral appliances in treating sleep apnea.
develop monitoring sensors that could be inserted into commercially avaialble oral
appliances in order to monitor effectiveness of the oral appliances in treating sleep apnea.
Oral appliances are an accepted means to treat obstructive sleep apnea. In order to
determine if they are effective a polysomnogram needs to be conducted with the oral
appliance in place. We propose to develop monitoring sensors that could be inserted into
commercially avaialble oral appliances in order to monitor effectiveness of the oral
appliances in treating sleep apnea. We propose to look at heart rate varaiability as a
marker for ongoing sleep apnea. We will use temperature as means of detecting how long the
device is in the mouth as a means of assessign adherence.
The objective of the Phase I project is to validate this hypothesis by answering five
questions:
- What is the optimal sensor suite? We will determine the optimal suite of sensors that
provides adequate sensitivity and specificity to determine OA usage and effectiveness
without compromising patient comfort.
- Can we develop designs that are compatible with the most popular OAs? We will design
and develop prototype versions of the OAMS that are compatible with three of the most
popular commercially available OAMS products (potential candidates include EMA, TAP,
SomnoDent, Herbst, Suad).
- Do experienced dental care providers who specialize in OAs approve of the designs? We
will collaborate with dental care clinicians to iteratively refine the OAMS design for
maximum performance and patient comfort.
- Does the OAMS provide data that are consistent with PSG instrumentation? We will
collaborate with the Dartmouth-Hitchcock Medical Center (DHMC) Sleep Disorders
Laboratory to assess OAMS sensor accuracy for approximately five healthy volunteers by
comparing OSA-related OAMS data with data from standard PSG instrumentation.
- Can we formulate a cogent Human Subject Testing plan for Phase II? We will develop a
detailed HST study plan to be conducted in Phase II to demonstrate fully integrated and
functional OAMS in a broad range of OSA patients who are candidates for an OA.
determine if they are effective a polysomnogram needs to be conducted with the oral
appliance in place. We propose to develop monitoring sensors that could be inserted into
commercially avaialble oral appliances in order to monitor effectiveness of the oral
appliances in treating sleep apnea. We propose to look at heart rate varaiability as a
marker for ongoing sleep apnea. We will use temperature as means of detecting how long the
device is in the mouth as a means of assessign adherence.
The objective of the Phase I project is to validate this hypothesis by answering five
questions:
- What is the optimal sensor suite? We will determine the optimal suite of sensors that
provides adequate sensitivity and specificity to determine OA usage and effectiveness
without compromising patient comfort.
- Can we develop designs that are compatible with the most popular OAs? We will design
and develop prototype versions of the OAMS that are compatible with three of the most
popular commercially available OAMS products (potential candidates include EMA, TAP,
SomnoDent, Herbst, Suad).
- Do experienced dental care providers who specialize in OAs approve of the designs? We
will collaborate with dental care clinicians to iteratively refine the OAMS design for
maximum performance and patient comfort.
- Does the OAMS provide data that are consistent with PSG instrumentation? We will
collaborate with the Dartmouth-Hitchcock Medical Center (DHMC) Sleep Disorders
Laboratory to assess OAMS sensor accuracy for approximately five healthy volunteers by
comparing OSA-related OAMS data with data from standard PSG instrumentation.
- Can we formulate a cogent Human Subject Testing plan for Phase II? We will develop a
detailed HST study plan to be conducted in Phase II to demonstrate fully integrated and
functional OAMS in a broad range of OSA patients who are candidates for an OA.
Inclusion Criteria:
- Ages 21-65
- Diagnosed with obstructive sleep apnea activeyl treated with an oral appliance or
interested in transiioting ot an oral appliance
- Ability to give informed consent
Exclusion Criteria:
- Significant phycial illness tht ight impari the ability to paricipate
- Pregnant women will be excluded
- Subjects presently takine medication such as beta blockers or alpha agonists know to
alter the autonomic nervous system
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