Evaluating Instrumentation for Dental Devices Used in Tre... | NCT02056327

Studies
Evaluating Instrumentation for Dental Devices Used in Treating Sleep Apnea

NCT02056327

Sponsor

Dartmouth-Hitchcock Medical Center

Status

Completed

Last Update Posted

Mar 27, 2014Estimated

Enrollment

2Actual

Phase

Not provided

Conditions

Obstructive Sleep Apnea

Interventions

A novel monitoring suite of sensors will be inserted into the standard oral device.

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Mar 2014Actual

Completion Date

Mar 2014Actual

First Submitted Date

Feb 4, 2014

First Submission Date that Met QC Criteria

Feb 4, 2014

First Posted Date

Feb 5, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2014

Last Update Posted Date

Mar 27, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Glen P. Greenough, Assistant Professor of Neurology and Psychiatry, Dartmouth-Hitchcock Medical CenterPrincipal Investigator

Lead Sponsor

Dartmouth-Hitchcock Medical CenterOTHER

Collaborators

Name	Class
Creare, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
A novel monitoring suite of sensors will be inserted into the standard oral device.	Device		Oral appliance with monitoring suite

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dartmouth-Hitchcock Medical Center		Lebanon	New Hampshire	03756	United States

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive

Ancestor Terms

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided