Recruiting

Observational Study

Sponsor:

Harvard School of Dental Medicine

Code:

NCT03299023

Conditions

Obstructive Sleep Apnea

Orthodontic Tooth Movement

Apnea

Sleep Disordered Breathing

Eligibility Criteria

Sex: All

Age: 8+

Healthy Volunteers: Accepted

Interventions

Medibyte Portable Monitor

Study Details

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

Study ID

NCT03299023

Start date

Jan 20, 2017

Status verified date

Sep, 2018

Completion date

Jun 10, 2019

Anticipated

Primary completion date

May 10, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8+

Healthy Volunteers: Accepted

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 Design

Enrollment

66 participants

Anticipated

Interventions and Outcome Measures

Interventions

Medibyte Portable Monitor

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

Primary outcome measure

  • Relationship between dental movements and AHI [ Time Frame: 2 Year ]
  • Relationship between skeletal changes and AHI [ Time Frame: 2 Year ]
  • Relationship between airway cephalometric changes and AHI [ Time Frame: 2 Year ]

Central Contacts and Locations

Central contacts

Shaima Tabari

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

Locations

Harvard School of Dental Medicine

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Shaima Tabari

415-851-0166shima_tabari@hsdm.harvard.edu

More Information

Sponsor

Harvard School of Dental Medicine

Last update posted

Sep 11, 2018

Last verified

Sep, 2018

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Harvard School of Dental Medicine on 2018-09-11.