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

NCT03299023 | Unknown

• 1 other identifier: R8-1648
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstructive Sleep Apnea; Orthodontic Tooth Movement; Apnea; Sleep Disordered Breathing

Keywords

Obstructive Sleep Apnea; Orthodontics; Tooth Movement; Medibyte; Apnea; Hypopnea; Sleep; Disturbed Breathing

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Relationship between the changes in the reported quality of life measurements and the AHI

  2 Year

Interventions

Medibyte Portable Monitor OTHER

Patients will be provided with the portable monitor in order to measure their apnea/hypopnea index.

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adults/children undergoing orthodontic care at HSDM

You may not qualify if:

• Patients already begun orthodontic therapy
• Patients obtaining orthognathic surgery
• Patients with high index of care need- have hypercapnia, hypoventilation, allergies or nose blockages

Sponsors & Collaborators

• Harvard School of Dental Medicine: lead

Study Sites (1)

Harvard School of Dental Medicine

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Apnea; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Shaima Tabari

CONTACT

415-851-0166; shaima_tabari@hsdm.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: September 13, 2017
• First Posted: October 2, 2017
• Study Start: January 20, 2017
• Primary Completion: May 10, 2019
• Study Completion: June 10, 2019
• Last Updated: September 11, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)