Changes in Upper Airway Anatomy, Quality of Life Measures, and Polysomnographic Parameters Using A Functional Dental Appliance

February 1, 2019 updated by: Steven Y. Park, Montefiore Medical Center
A prospective study measuring changes in upper airway anatomy, quality of life measures, and polysomnographic parameters using a functional dental appliance (Homeoblock)

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Although rising levels of obesity heavily influences the increasing rates of obstructive sleep apnea (OSA), detailed analysis of more basic etiology suggests a possible craniofacial origin. Specifically, modern humans' facial structures a slowly shrinking, which can narrow the upper airway. This is evidenced by the fact that rates of malocclusion and impacted (or non-existent) wisdom teeth are increasing in modern, Westernized countries.

Obstructive sleep apnea is a commonly seen condition characterized by multiple episodes of obstructed breathing during sleep, with intermittent hypoxia. Untreated OSA is associated with significantly higher rates of high blood pressure, diabetes, heart disease, heart attack, stroke, sudden death, and car accidents. The gold standard treatment for OSA is continuous positive airway pressure (CPAP), but compliance is poor. Initially, out of 100 patients, 20 will refuse CPAP. After one year 50% of the 80 remaining patients will be using CPAP, but only 50% will be using it effectively, leaving only 20 patients who are using CPAP effectively. (personal communication, Stepnowski).

An alternative option in people with mild to moderate OSA is a mandibular advancement device, which functions by pulling the genioglossus muscle forward. Long-term use of CPAP and mandibular advancement devices have been shown to aggravate malocclusion. Numerous surgical options are available for select patients, but only as a last resort.

In children, one uncommonly used, but effective form of treating OSA is by application of a palatal expander by an orthodontist. In theory, this option is effective due to the fact the palatal suture line is not completely fused in children. The general consensus in dentistry is that adults have fused midline palatal suture line and the hard palate cannot be expanded.

Recent work by numerous investigators suggests that palatal expansion can occur to significant degrees, even in adults. Case reports have been published with the AHI diminishing significantly after therapy. Not only can the hard palate widen, there can also be significant growth of new maxillary bone growth and anterior mandibular bone growth. Jaw development is linked to airway development.

The Homeoblock is once such appliance that is based on principles of epigenetics. Mechanical stimulation by the device is thought to initiate gene transcription within the periodontal ligament, creating dental movement and new bone formation.

Our study aims to determine the efficacy of the Homeoblock in patients with obstructive sleep apnea with regards to changes in polysomnographic parameters, functional quality of life measures, and upper airway anatomy size using low-dose CT imaging.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Documented AHI > 15 on polysomnography
  • Refuses CPAP
  • Able to fill our QOL and sleep questionnaires (pre and one year post treatment)
  • Willing to undergo CBCT radiologic testing x 2 (pre and 1 year post treatment)

Exclusion Criteria:

  • neurologic conditions
  • dementia
  • central sleep apnea
  • heart failure, seizures
  • age < 18
  • severe nasal congestion
  • insufficient teeth
  • lack of manual dexterity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Homeoblock functional dental appliance
Removable functional dental appliance to be used at during sleep for one year.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Polysomnographic (PSG) parameters, mainly AHI and O2 desaturation measures
Time Frame: Through study completion. Data to be re-collected after one year of therapy for each participant
Comparison of PSG data between pre-therapy and post-therapy values at one year
Through study completion. Data to be re-collected after one year of therapy for each participant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epworth Sleepiness Scale
Time Frame: Comparison of data between pre-therapy and post-therapy values at one year for each participant
Commonly used validated tool for sleep research
Comparison of data between pre-therapy and post-therapy values at one year for each participant
Functional Outcome of Sleep Questionnaire (FOSQ)
Time Frame: Comparison of data between pre-therapy and post-therapy values at one year for each participant
Commonly used validated tool for sleep research
Comparison of data between pre-therapy and post-therapy values at one year for each participant
Nasal obstruction symptom evaluation (NOSE)
Time Frame: Comparison of data between pre-therapy and post-therapy values at one year for each participant
Commonly used validated tool for otolaryngology research
Comparison of data between pre-therapy and post-therapy values at one year for each participant
Upper airway volume changes based on low-dose CT imaging (CBCT)
Time Frame: Comparison of CBCT data between pre-therapy and post-therapy values at one year
Various upper ariway volume measurements as well as craniofacial landmarks Orthodontists routinely perform periodic CBCT imaging to assess progress. A one year interval is well within standards of care.
Comparison of CBCT data between pre-therapy and post-therapy values at one year
BMI
Time Frame: Comparison of data between pre-therapy and post-therapy values at one year
Comparison of data between pre-therapy and post-therapy values at one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2018

Primary Completion (Anticipated)

January 2, 2019

Study Completion (Actual)

January 2, 2019

Study Registration Dates

First Submitted

May 31, 2016

First Submitted That Met QC Criteria

June 15, 2016

First Posted (Estimate)

June 20, 2016

Study Record Updates

Last Update Posted (Actual)

February 5, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-4845

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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