Obstructive Sleep ApneaNCT03299023
The Effect of Tooth Position During Orthodontic Treatment on the Apnea/ Hypopnea Index (AHI)
An observational study of Obstructive Sleep Apnea and Orthodontic Tooth Movement, run by Harvard School of Dental Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea, Orthodontic Tooth Movement, Apnea
- What is being tested?
- Medibyte Portable Monitor
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2017to 10 Jun 2019
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Adults/children undergoing orthodontic care at HSDM
Who cannot join
- Patients already begun orthodontic therapy
- Patients obtaining orthognathic surgery
- Patients with high index of care need- have hypercapnia, hypoventilation, allergies or nose blockages
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Harvard School of Dental Medicine
Boston, Massachusetts, 02115
Shaima Tabari, 415-851-0166, shima_tabari@hsdm.harvard.edu
About this study
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.
Read the 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.
- Being tested
- Medibyte Portable Monitor
- Keywords
- Obstructive Sleep Apnea, Orthodontics, Tooth Movement, Medibyte, Apnea, Hypopnea, Sleep, Disturbed Breathing
- Medical subject headings
- Sleep Apnea, Obstructive, Apnea, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medibyte Portable MonitorOther
Patients will be provided with the portable monitor in order to measure their apnea/hypopnea index.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 2 Year
Secondary outcomes (1)
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.
Measured: 2 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2017
- Study start20 Jan 2017
- Primary completion10 May 2019 (estimated)
- Study completion10 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 66 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Harvard School of Dental Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Shaima Tabari, Harvard School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299023
- Sponsor's protocol ID
- R8-1648
- Status last verified
- Sep 2018
- First submitted
- 13 Sep 2017
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tooth Position During Orthodontic Treatment on the Apnea/ Hypopnea Index (AHI)
- ClinicalTrials.gov ID
- NCT03299023
- Acronym / sponsor ID
- R8-1648
- Keywords
- Obstructive Sleep Apnea, Orthodontics, Tooth Movement, Medibyte, Apnea, Hypopnea, Sleep, Disturbed Breathing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Harvard School of Dental MedicineUniversity, hospital or other
- Study start
- 20 Jan 2017 (actual)
- Primary completion
- 10 May 2019 (estimated)
- Study completion
- 10 Jun 2019 (estimated)
- First posted
- 2 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Adults/children undergoing orthodontic care at HSDM
Key exclusion criteria (3 listed)
- Patients already begun orthodontic therapy
- Patients obtaining orthognathic surgery
- Patients with high index of care need- have hypercapnia, hypoventilation, allergies or nose blockages
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medibyte Portable MonitorPatients will be provided with the portable monitor in order to measure their apnea/hypopnea index. | Other | – |
Primary outcome
Relationship between dental movements and AHI
Time frame: 2 Year
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.
Relationship between skeletal changes and AHI
Time frame: 2 Year
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
Relationship between airway cephalometric changes and AHI
Time frame: 2 Year
This outcome aims to measure any changes in the airway cephalometric measurements such as the upper/middle/superior airway space etc. and the AHI
1 secondary outcome
Relationship between the changes in the reported quality of life measurements and the AHI
Time frame: 2 Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea and Orthodontic Tooth Movement, run by Harvard School of Dental Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shaima Tabari (415-851-0166, shaima_tabari@hsdm.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between dental movements and AHI (time frame: 2 Year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2018.