Changes in Upper Airway Anatomy, Quality of Life Measures, and Polysomnographic Parameters Using A Functional Dental Appliance
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| ClinicalTrials.gov Identifier: NCT02805764 |
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Recruitment Status :
Withdrawn
(No suitable candidates)
First Posted : June 20, 2016
Last Update Posted : February 5, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Obstructive Sleep Apnea Malocclusion | Device: Homeoblock | Not Applicable |
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 (Clinical Trial) |
| Actual Enrollment : | 0 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Changes in Upper Airway Anatomy, Quality of Life Measures, and Polysomnographic Parameters Using A Functional Dental Appliance |
| Actual Study Start Date : | April 1, 2018 |
| Estimated Primary Completion Date : | January 2, 2019 |
| Actual Study Completion Date : | January 2, 2019 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Homeoblock functional dental appliance
Removable functional dental appliance to be used at during sleep for one year.
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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. |
- 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
- 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
- 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
- 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
- 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.
- BMI [ Time Frame: Comparison of data between pre-therapy and post-therapy values at one year ]
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805764
| United States, New York | |
| Montefiore Medical Center | |
| Bronx, New York, United States, 10467 | |
| Responsible Party: | Steven Y. Park, Attending Surgeon / Assistant Professor - Otorhinolaryngology, Montefiore Medical Center |
| ClinicalTrials.gov Identifier: | NCT02805764 |
| Other Study ID Numbers: |
2015-4845 |
| First Posted: | June 20, 2016 Key Record Dates |
| Last Update Posted: | February 5, 2019 |
| Last Verified: | February 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
| Device Product Not Approved or Cleared by U.S. FDA: | Yes |
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obstructive sleep apnea malocclusion polysomnography quality of life |
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Malocclusion Sleep Apnea Syndromes Sleep Apnea, Obstructive Apnea Respiration Disorders Respiratory Tract Diseases |
Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases Tooth Diseases Stomatognathic Diseases |