The Effect of Tooth Position During Orthodontic Treatment on the Apnea/ Hypopnea Index (AHI)

Obstructive Sleep Apnea Clinical Trial

Official title:

The Effect of Tooth Position During Orthodontic Treatment on the Apnea/ Hypopnea Index (AHI)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03299023
• Other study ID #: R8-1648
• Status: Recruiting
• Start date: January 20, 2017
• Est. completion date: June 10, 2019

Study information

• Verified date: September 2018
• Source: Harvard School of Dental Medicine
• Contact: Shaima Tabari
• Phone: 415-851-0166
• Email: shaima_tabari[@]hsdm.harvard.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The study design of this research project involves orthodontic patients registered at the Harvard School of Dental Medicine who are deemed eligible to undergo orthodontic treatment and who have been provided with sufficient information to make informed consent to join the sleep study. These patients will be provided with the Medibyte sleep monitor and instructed on the proper manner in which it should be set up and worn for the one night study period. This process will be carried out twice throughout the course of the study, once before any orthodontic appliance has been cemented and once after the required amount of tooth movement has been attained with the orthodontic appliance still in place.

The de-identified data from the Medibyte monitor will be downloaded using the Braebon software and analyzed.

Description:

The study design of this research project involves recruiting orthodontic patients registered at the Harvard School of Dental Medicine who are deemed eligible to undergo orthodontic treatment and who have been provided with sufficient information to make informed consent to join the sleep study. The participants will be provided with the Medibyte sleep monitor and instructed on the proper manner in which it should be set up and worn for the one or two night study period. The purpose of the Medibyte monitor is solely to provide a calibrated value of AHI. The Medibyte monitor will not be utilized for investigations and/or treat, cure, mitigate a medical condition. This process will be carried out twice throughout the course of the study, once before any orthodontic appliance has been cemented and once after the required amount of tooth movement has been attained with the orthodontic appliance still in place.

The de-identified data from the Medibyte monitor will be downloaded using the Braebon software and analyzed providing a baseline value and post orthodontic movement AHI value. Additionally the patients arch width, length and other orthodontic measurements will also be taken both from their 3-D dental models and also their 2-D lateral cephalogram x-ray all of which are part of the routine orthodontic records (the x-rays will be taken regardless of the patients participation in the study since they are a required component of the orthodontic records taken at HSDM). The values obtained from the patients casts, lateral cephalogram and Medibyte AHI values will be analyzed both pre-orthodontic appliance cementation and also post tooth movement. The changes, if any, in the dental parameters as compared with the AHI values will allow the investigation of the orthodontic effects of expanding the maxilla, moving the front teeth either forwards or backwards which in effect cause changes to the airway and its effect on AHI values during sleep. In addition to the measurements taken intra-orally, surveys will also be undertaken to study any changes the patients may experience in their sleep and quality of life. If the Medibyte shows a severe reading for obstructive sleep apnea, these patients will then be referred to a sleep specialist for further more conclusive testing.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: June 10, 2019
• Est. primary completion date: May 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years and older

Eligibility

Inclusion Criteria:

• Adults/children undergoing orthodontic care at HSDM

Exclusion Criteria:

• Patients already begun orthodontic therapy

• Patients obtaining orthognathic surgery

• Patients with high index of care need- have hypercapnia, hypoventilation, allergies or nose blockages

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Orthodontic Tooth Movement
• Respiratory Aspiration
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleep Disordered Breathing

Intervention

Other:
• Medibyte Portable Monitor
Patients will be provided with the portable monitor in order to measure their apnea/hypopnea index.

Locations

Country	Name	City	State
United States	Harvard School of Dental Medicine	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Harvard School of Dental Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship between dental movements and AHI	This outcome aims to measure any changes in the dental measurements such as arch length, arch perimeter, inter-canine and inter-molar changes on the AHI value.	2 Year
Primary	Relationship between skeletal changes and AHI	This outcome aims to measure any changes in the skeletal changes such as SNA, SNB, ANB etc. as measured by the lateral cephalogram and any changes in the AHI	2 Year
Primary	Relationship between airway cephalometric changes and AHI	This outcome aims to measure any changes in the airway cephalometric measurements such as the upper/middle/superior airway space etc. and the AHI	2 Year
Secondary	Relationship between the changes in the reported quality of life measurements and the AHI	This outcome aims to measure any changes in the reported quality of life measurements as measured by questionnaires such as conners, epworth, pediatric quality of life and pediatric sleep quesitonnaire and the AHI vale.	2 Year