Brief Summary
A prospective study measuring changes in upper airway anatomy, quality of life measures, and polysomnographic parameters using a functional dental appliance (Homeoblock)
Brief Title
Changes in Upper Airway Anatomy, Quality of Life Measures, and Polysomnographic Parameters Using A Functional Dental Appliance
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.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Obstructive Sleep Apnea
Malocclusion
Eligibility Criteria
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
* 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
Inclusion Criteria
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)
* 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)
Gender
All
Gender Based
false
Keywords
obstructive sleep apnea
malocclusion
polysomnography
quality of life
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
65 Years
Minimum Age
18 Years
NCT Id
NCT02805764
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2015-4845
Overall Status
Withdrawn
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Changes in Upper Airway Anatomy, Quality of Life Measures, and Polysomnographic Parameters Using A Functional Dental Appliance
Primary Outcomes
Outcome Description
Comparison of PSG data between pre-therapy and post-therapy values at one year
Outcome Measure
Polysomnographic (PSG) parameters, mainly AHI and O2 desaturation measures
Outcome Time Frame
Through study completion. Data to be re-collected after one year of therapy for each participant
Secondary Outcomes
Outcome Description
Commonly used validated tool for sleep research
Outcome Time Frame
Comparison of data between pre-therapy and post-therapy values at one year for each participant
Outcome Measure
Epworth Sleepiness Scale
Outcome Description
Commonly used validated tool for sleep research
Outcome Time Frame
Comparison of data between pre-therapy and post-therapy values at one year for each participant
Outcome Measure
Functional Outcome of Sleep Questionnaire (FOSQ)
Outcome Description
Commonly used validated tool for otolaryngology research
Outcome Time Frame
Comparison of data between pre-therapy and post-therapy values at one year for each participant
Outcome Measure
Nasal obstruction symptom evaluation (NOSE)
Outcome Description
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.
Outcome Time Frame
Comparison of CBCT data between pre-therapy and post-therapy values at one year
Outcome Measure
Upper airway volume changes based on low-dose CT imaging (CBCT)
Outcome Time Frame
Comparison of data between pre-therapy and post-therapy values at one year
Outcome Measure
BMI
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
65
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Steven Park
Investigator Email
stpark@montefiore.org
Investigator Phone
929-263-3134