Evaluating Instrumentation for Dental Devices Used in Treating Sleep Apnea

NCT02056327 | Completed

• 1 other identifier: HHSN268201300056C
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

Oral Appliance

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

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

Oral appliance with monitoring suite

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Creare, Inc.: collaborator

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology and Psychiatry

Study Record Dates

• First Submitted: February 4, 2014
• First Posted: February 5, 2014
• Study Start: November 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: March 27, 2014

Record last verified: 2014-03

Locations

US (1)