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Evaluating Instrumentation for Dental Devices Used in Treating Sleep Apnea

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ClinicalTrials.gov Identifier: NCT02056327
Recruitment Status : Completed
First Posted : February 5, 2014
Last Update Posted : March 27, 2014
Sponsor:
Collaborator:
Creare, Inc.
Information provided by (Responsible Party):
Glen P. Greenough, Dartmouth-Hitchcock Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment
Obstructive Sleep Apnea 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.

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Study Type : Observational
Actual Enrollment : 2 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Phase One Study Evaluating Instrumentation for Dental Devices Used in Treating Sleep Apnea
Study Start Date : November 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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.



Primary Outcome Measures :
  1. Polysomnography [ Time Frame: One to two nights ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056327


Locations
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United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Creare, Inc.
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Responsible Party: Glen P. Greenough, Assistant Professor of Neurology and Psychiatry, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT02056327    
Other Study ID Numbers: HHSN268201300056C
First Posted: February 5, 2014    Key Record Dates
Last Update Posted: March 27, 2014
Last Verified: March 2014
Keywords provided by Glen P. Greenough, Dartmouth-Hitchcock Medical Center:
Oral Appliance
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases