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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02805764
• Other study ID #: 2015-4845
• Status: Withdrawn
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: January 2, 2019

Study information

• Verified date: February 2019
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A prospective study measuring changes in upper airway anatomy, quality of life measures, and polysomnographic parameters using a functional dental appliance (Homeoblock)

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2, 2019
• Est. primary completion date: January 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Malocclusion
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (8)

Belfor TR, Singh GD. Developing dental arch symmetry using the Homeoblock device. Int J Orthod Milwaukee. 2004 Fall;15(3):27-30. — View Citation

Chen 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. — View Citation

Corruccini RS. An epidemiologic transition in dental occlusion in world populations. Am J Orthod. 1984 Nov;86(5):419-26. — View Citation

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. — View Citation

Li 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. — View Citation

Machado-Júnior 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. Review. — View Citation

Singh 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. — View Citation

Singh GD, Wendling S, Chandrashekhar R. Midfacial development in adult obstructive sleep apnea. Dent Today. 2011 Jul;30(7):124-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Polysomnographic (PSG) parameters, mainly AHI and O2 desaturation measures	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	Epworth Sleepiness Scale	Commonly used validated tool for sleep research	Comparison of data between pre-therapy and post-therapy values at one year for each participant
Secondary	Functional Outcome of Sleep Questionnaire (FOSQ)	Commonly used validated tool for sleep research	Comparison of data between pre-therapy and post-therapy values at one year for each participant
Secondary	Nasal obstruction symptom evaluation (NOSE)	Commonly used validated tool for otolaryngology research	Comparison of data between pre-therapy and post-therapy values at one year for each participant
Secondary	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.	Comparison of CBCT data between pre-therapy and post-therapy values at one year
Secondary	BMI		Comparison of data between pre-therapy and post-therapy values at one year