Study Stopped
No suitable candidates
Changes in Upper Airway Anatomy, Quality of Life Measures, and Polysomnographic Parameters Using A Functional Dental Appliance
1 other identifier
interventional
N/A
1 country
1
Brief Summary
A prospective study measuring changes in upper airway anatomy, quality of life measures, and polysomnographic parameters using a functional dental appliance (Homeoblock)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2016
CompletedFirst Posted
Study publicly available on registry
June 20, 2016
CompletedStudy Start
First participant enrolled
April 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 2, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 2, 2019
CompletedFebruary 5, 2019
February 1, 2019
9 months
May 31, 2016
February 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Epworth Sleepiness Scale
Comparison of data between pre-therapy and post-therapy values at one year for each participant
Functional Outcome of Sleep Questionnaire (FOSQ)
Comparison of data between pre-therapy and post-therapy values at one year for each participant
Nasal obstruction symptom evaluation (NOSE)
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)
Comparison of CBCT data between pre-therapy and post-therapy values at one year
BMI
Comparison of data between pre-therapy and post-therapy values at one year
Study Arms (1)
Homeoblock functional dental appliance
EXPERIMENTALRemovable functional dental appliance to be used at during sleep for one year.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- neurologic conditions
- dementia
- central sleep apnea
- heart failure, seizures
- age \< 18
- severe nasal congestion
- insufficient teeth
- lack of manual dexterity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Montefiore Medical Center
The Bronx, New York, 10467, United States
Related Publications (8)
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.
PMID: 9341055BACKGROUNDCorruccini 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.
PMID: 6594064BACKGROUNDChen 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.
PMID: 18774087BACKGROUNDLi 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.
PMID: 10713032BACKGROUNDMachado-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.
PMID: 27031063BACKGROUNDSingh 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.
PMID: 23971157BACKGROUNDSingh GD, Wendling S, Chandrashekhar R. Midfacial development in adult obstructive sleep apnea. Dent Today. 2011 Jul;30(7):124-7. No abstract available.
PMID: 21845821BACKGROUNDBelfor TR, Singh GD. Developing dental arch symmetry using the Homeoblock device. Int J Orthod Milwaukee. 2004 Fall;15(3):27-30. No abstract available.
PMID: 15553991BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending Surgeon / Assistant Professor - Otorhinolaryngology
Study Record Dates
First Submitted
May 31, 2016
First Posted
June 20, 2016
Study Start
April 1, 2018
Primary Completion
January 2, 2019
Study Completion
January 2, 2019
Last Updated
February 5, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share