Evaluating Instrumentation for Dental Devices Used in Treating Sleep Apnea

Phase One Study Evaluating 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 available oral appliances in order to monitor effectiveness of the oral appliances in treating sleep apnea.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: A novel monitoring suite of sensors will be inserted into the standard oral device.

Detailed Description

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 available oral appliances in order to monitor effectiveness of the oral appliances in treating sleep apnea. We propose to look at heart rate variability 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 assessing 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.

• Study Type: Observational
• Enrollment (Actual): 2

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults diagnosed with obstructive sleep apnea who are currently being treated with an oral appliance or who wish to transition to an oral appliance

Description

Inclusion Criteria:

• Ages 21-65
• Diagnosed with obstructive sleep apnea actively treated with an oral appliance or interested in transitioning to an oral appliance
• Ability to give informed consent

Exclusion Criteria:

• Significant physical illness that might impair the ability to participate
• Pregnant women will be excluded
• Subjects presently taking medication such as beta blockers or alpha agonists know to alter the autonomic nervous system

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Oral appliance with monitoring suite; Subjects will sleep with a standard oral appliance with the newly developed monitoring suite embedded within it for 1-2 nights while being monitored with standard in lab polysomnography or home sleep testing.	Device: A novel monitoring suite of sensors will be inserted into the standard oral device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Polysomnography	We will perform standard in-lab polysomnography or home sleep testing to assess the ability of the sensors embedded in the oral appliance to detect ongoing obstructive sleep apnea	One to two nights

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: Creare, Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: February 4, 2014
• First Submitted That Met QC Criteria: February 4, 2014
• First Posted (Estimate): February 5, 2014

Study Record Updates

• Last Update Posted (Estimate): March 27, 2014
• Last Update Submitted That Met QC Criteria: March 25, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Oral Appliance
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: HHSN268201300056C