Obstructive Sleep ApneaNCT02805764
Changes in Upper Airway Anatomy, Quality of Life Measures, and Polysomnographic Parameters Using A Functional Dental Appliance
A study testing Homeoblock in people with Obstructive Sleep Apnea and Malocclusion, run by Montefiore Medical Center at 1 site in United States.
Trial summary
A prospective study measuring changes in upper airway anatomy, quality of life measures, and polysomnographic parameters using a functional dental appliance (Homeoblock) Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea, Malocclusion
- What is being tested?
- Homeoblock
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2018to 2 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- neurologic conditions
- dementia
- central sleep apnea
- heart failure, seizures
- age < 18
- severe nasal congestion
- insufficient teeth
- lack of manual dexterity
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
A prospective study measuring changes in upper airway anatomy, quality of life measures, and polysomnographic parameters using a functional dental appliance (Homeoblock)
Read the 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.
- Conditions
- Obstructive Sleep Apnea, Malocclusion
- Being tested
- Homeoblock
- Keywords
- obstructive sleep apnea, malocclusion, polysomnography, quality of life
- Medical subject headings
- Sleep Apnea, Obstructive, Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HomeoblockDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Homeoblock functional dental appliance | Experimental | Removable functional dental appliance to be used at during sleep for one year. Receives: Device: Homeoblock |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polysomnographic (PSG) parameters, mainly AHI and O2 desaturation measures
Comparison of PSG data between pre-therapy and post-therapy values at one year
Measured: Through study completion. Data to be re-collected after one year of therapy for each participant
Secondary outcomes (5)
Epworth Sleepiness Scale
Commonly used validated tool for sleep research
Measured: Comparison of data between pre-therapy and post-therapy values at one year for each participant
Functional Outcome of Sleep Questionnaire (FOSQ)
Commonly used validated tool for sleep research
Measured: Comparison of data between pre-therapy and post-therapy values at one year for each participant
Nasal obstruction symptom evaluation (NOSE)
Commonly used validated tool for otolaryngology research
Measured: 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)
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.
Measured: Comparison of CBCT data between pre-therapy and post-therapy values at one year
BMI
Measured: Comparison of data between pre-therapy and post-therapy values at one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study start1 Apr 2018
- Primary completion2 Jan 2019 (estimated)
- Study completion2 Jan 2019
Why it stopped: No suitable candidates
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Y. Park, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02805764
- Sponsor's protocol ID
- 2015-4845
- Status last verified
- Feb 2019
- First submitted
- 31 May 2016
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kushida CA, Efron B, Guilleminault C. A predictive morphometric model for the obstructive sleep apnea syndrome. Ann Intern Med. 1997 Oct 15;127(8 Pt 1):581-7. doi: 10.7326/0003-4819-127-8_part_1-199710150-00001.
PubMed 9341055Corruccini RS. An epidemiologic transition in dental occlusion in world populations. Am J Orthod. 1984 Nov;86(5):419-26. doi: 10.1016/s0002-9416(84)90035-6.
PubMed 6594064Chen H, Lowe AA, de Almeida FR, Fleetham JA, Wang B. Three-dimensional computer-assisted study model analysis of long-term oral-appliance wear. Part 2. Side effects of oral appliances in obstructive sleep apnea patients. Am J Orthod Dentofacial Orthop. 2008 Sep;134(3):408-17. doi: 10.1016/j.ajodo.2006.10.031.
PubMed 18774087Li KK, Riley RW, Guilleminault C. An unreported risk in the use of home nasal continuous positive airway pressure and home nasal ventilation in children: mid-face hypoplasia. Chest. 2000 Mar;117(3):916-8. doi: 10.1378/chest.117.3.916.
PubMed 10713032Machado-Junior AJ, Zancanella E, Crespo AN. Rapid maxillary expansion and obstructive sleep apnea: A review and meta-analysis. Med Oral Patol Oral Cir Bucal. 2016 Jul 1;21(4):e465-9. doi: 10.4317/medoral.21073.
PubMed 27031063Singh GD, Callister JD. Effect of a maxillary appliance in an adult with obstructive sleep apnea: a case report. Cranio. 2013 Jul;31(3):171-5. doi: 10.1179/crn.2013.027.
PubMed 23971157Singh GD, Wendling S, Chandrashekhar R. Midfacial development in adult obstructive sleep apnea. Dent Today. 2011 Jul;30(7):124-7. No abstract available.
PubMed 21845821Belfor TR, Singh GD. Developing dental arch symmetry using the Homeoblock device. Int J Orthod Milwaukee. 2004 Fall;15(3):27-30. No abstract available.
PubMed 15553991
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Upper Airway Anatomy, Quality of Life Measures, and Polysomnographic Parameters Using A Functional Dental Appliance
- ClinicalTrials.gov ID
- NCT02805764
- Acronym / sponsor ID
- 2015-4845
- Conditions
- Obstructive Sleep Apnea, Malocclusion
- Keywords
- obstructive sleep apnea, malocclusion, polysomnography, quality of life
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No suitable candidates
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 2 Jan 2019 (estimated)
- Study completion
- 2 Jan 2019 (actual)
- First posted
- 20 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective study measuring changes in upper airway anatomy, quality of life measures, and polysomnographic parameters using a functional dental appliance (Homeoblock)
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Homeoblock functional dental appliance | Experimental | Device: HomeoblockRemovable functional dental appliance to be used at during sleep for one year. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- neurologic conditions
- dementia
- central sleep apnea
- heart failure, seizures
- age < 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HomeoblockA 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. | Device | Homeoblock functional dental appliance |
Primary outcome
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
5 secondary outcomes
Epworth Sleepiness Scale
Time frame: 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
Nasal obstruction symptom evaluation (NOSE)
Time frame: 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
BMI
Time frame: Comparison of data between pre-therapy and post-therapy values at one year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Background: PubMed 9341055Kushida CA, Efron B, Guilleminault C. A predictive morphometric model for the obstructive sleep apnea syndrome. Ann Intern Med. 1997 Oct 15;127(8 Pt 1):581-7. doi: 10.7326/0003-4819-127-8_part_1-199710150-00001.
- Background: PubMed 6594064Corruccini RS. An epidemiologic transition in dental occlusion in world populations. Am J Orthod. 1984 Nov;86(5):419-26. doi: 10.1016/s0002-9416(84)90035-6.
- Background: PubMed 18774087Chen H, Lowe AA, de Almeida FR, Fleetham JA, Wang B. Three-dimensional computer-assisted study model analysis of long-term oral-appliance wear. Part 2. Side effects of oral appliances in obstructive sleep apnea patients. Am J Orthod Dentofacial Orthop. 2008 Sep;134(3):408-17. doi: 10.1016/j.ajodo.2006.10.031.
- Background: PubMed 10713032Li KK, Riley RW, Guilleminault C. An unreported risk in the use of home nasal continuous positive airway pressure and home nasal ventilation in children: mid-face hypoplasia. Chest. 2000 Mar;117(3):916-8. doi: 10.1378/chest.117.3.916.
- Background: PubMed 27031063Machado-Junior AJ, Zancanella E, Crespo AN. Rapid maxillary expansion and obstructive sleep apnea: A review and meta-analysis. Med Oral Patol Oral Cir Bucal. 2016 Jul 1;21(4):e465-9. doi: 10.4317/medoral.21073.
- Background: PubMed 23971157Singh GD, Callister JD. Effect of a maxillary appliance in an adult with obstructive sleep apnea: a case report. Cranio. 2013 Jul;31(3):171-5. doi: 10.1179/crn.2013.027.
- Background: PubMed 21845821Singh GD, Wendling S, Chandrashekhar R. Midfacial development in adult obstructive sleep apnea. Dent Today. 2011 Jul;30(7):124-7. No abstract available.
- Background: PubMed 15553991Belfor TR, Singh GD. Developing dental arch symmetry using the Homeoblock device. Int J Orthod Milwaukee. 2004 Fall;15(3):27-30. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Homeoblock in people with Obstructive Sleep Apnea and Malocclusion, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02805764, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2019.