Changes in Upper Airway Anatomy, Quality of Life Measures, and Polysomnographic Parameters Using A Functional Dental Appliance
NCT02805764 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2019-02-05
Summary
A prospective study measuring changes in upper airway anatomy, quality of life measures, and polysomnographic parameters using a functional dental appliance (Homeoblock)
Conditions
- Obstructive Sleep Apnea
- Malocclusion
Interventions
- DEVICE
-
Homeoblock
A removable, functional dental appliance to be worn nightly for 1 year Pending 510(k) clearance for the use of reducing snoring and mild to moderate obstructive sleep apnea in adults. A class II medical device.
Sponsors & Collaborators
-
Montefiore Medical Center
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-04-01
- Primary Completion
- 2019-01-02
- Completion
- 2019-01-02
- FDA Device
- Yes
Countries
- United States
Study Locations
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