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

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.

Study Overview

• Status: Unknown
• Conditions: Apnea; Obstructive Sleep Apnea; Sleep Disordered Breathing; Orthodontic Tooth Movement
• Intervention / Treatment: Other: Medibyte Portable Monitor

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 66

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Harvard School of Dental Medicine
      • Contact: Shaima Tabari; Phone Number: 415-851-0166; Email: shima_tabari@hsdm.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will include patients already registered at the Harvard School of Dental Medicine department of Orthodontics. Informed consent will be obtained before the questionnaires and portable monitor will be provided.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Harvard School of Dental Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2017
• Primary Completion (Anticipated): May 10, 2019
• Study Completion (Anticipated): June 10, 2019

Study Registration Dates

• First Submitted: September 13, 2017
• First Submitted That Met QC Criteria: September 29, 2017
• First Posted (Actual): October 2, 2017

Study Record Updates

• Last Update Posted (Actual): September 11, 2018
• Last Update Submitted That Met QC Criteria: September 10, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Obstructive Sleep Apnea; Sleep; Apnea; Orthodontics; Hypopnea; Tooth Movement; Medibyte; Disturbed Breathing
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Respiratory Aspiration; Apnea
• Other Study ID Numbers: R8-1648

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No