Sleep Apnea SyndromePhase 4NCT01164631
Pharyngeal Size in Patients With Obstructive Tonsils Under Orthodontic Treatment
A Phase 4 study testing Bioajusta X Orthodontic treatment in people with Sleep Apnea Syndrome and Malocclusion, run by University of Sao Paulo General Hospital.
Trial summary
Enlarged tonsils and malocclusion have relationship with sleep disturbance in children. The consequences of these features can include deviation of normal craniofacial growth such that this may result in a facial morphology more suitable to the development of sleep apnea later in life. Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Sleep Apnea Syndrome, Malocclusion
- What is being tested?
- Bioajusta X Orthodontic treatment
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Nov 2006to Nov 2009
- Phase
- Phase 4
- 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 6 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 6 to 9 years of age with tonsils degree 3 or 4 ,
- Sleep snores and narrow maxilla or class II malocclusion.
Who cannot join
- Neurological diseases,
- Tooth missing ,
- Previous orthodontic treatment.
About this study
Official title: Improvement of Pharyngeal Size in Patients With Obstructive Tonsils Treated With Bioajusta X Orthodontic Appliance - Randomized Clinical Trial
Enlarged tonsils and malocclusion have relationship with sleep disturbance in children. The consequences of these features can include deviation of normal craniofacial growth such that this may result in a facial morphology more suitable to the development of sleep apnea later in life. The aim of this study was to compare the growth redirection, the evolution of respiratory symptoms and the pharyngeal size of snoring children with obstructive tonsils from the waiting list for surgery treated with the Bioajusta X orthodontic appliance.This new protocol of orthodontic treatment promotes maxillary expansion, mandibular advancement and proper tongue positioning on swallowing , that together may be helpful on remodeling the upper airways.
Read the detailed description
Methods-The study population included 40 children, ranging in age from 6 to 9 years old, who were on the waiting list for adenotonsillectomy at the ENT Department of FMUSP. The patients were randomly divided into two groups and were subsequently compared after a six month interval. The first group included 24 patients who where treated with the Bioajusta X appliance and the second group included 16 patients who served as controls, and,thus, did not received any treatment. Cephalometric analysis was used to assess the growth direction by comparing the relationship of the vertical jaw based upon the angle of the palatal plane with the mandibular plane (ANS-PNS/Go-M).Pharyngeal size was measured using acoustic pharyngometry. The parents filled out a questionnaire with respect to the respiratory symptoms of their children.
- Conditions
- Sleep Apnea Syndrome, Malocclusion
- Being tested
- Bioajusta X Orthodontic treatment
- Keywords
- Sleep Apnea Syndrome, Orthodontics, Tonsillectomy, Child
- Medical subject headings
- Sleep Apnea Syndromes, Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioajusta X Orthodontic treatmentDevice
Also called Oral appliance, Orthodontic Treatment, Orofacial Orthopedics
Oral Appliance that promotes semi-rapid maxillary expansion, while corrects tongue positioning and jaws relationship
| Study group | Role | What they receive |
|---|---|---|
| Orthodontic treatment | Experimental | Snoring patients enrolling for tonsil surgery with maxillary constriction, and/or jaw retrognathism Receives: Device: Bioajusta X Orthodontic treatment |
| Control Group | No intervention | Patients enrolled for tonsils surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the facial growth
Facial X rays exams were measured from both groups (treatment and control) and compared in a six month interval, in respect to sleep apnea predictors
Measured: six months
Secondary outcomes (1)
Pharyngeal Size
Pharyngeal size was studied with acoustic pharyngometry and data compared between treated and control groups
Measured: six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2010 (estimated)
- Study startNov 2006
- Primary completionDec 2008
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea SyndromeStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Eduardo Moacyr Krieger, University of Sao Paulo General Hospital
- Investigators
- Renata C Di Francesco, Phd, Study director, University of Sao Paulo General HospitalWalter R Nunes Jr., Ms, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01164631
- Sponsor's protocol ID
- FAPESP - 06/57695-7
- Status last verified
- Jun 2012
- First submitted
- 30 Jun 2010
- Last updated
- 22 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Pharyngeal Size in Patients With Obstructive Tonsils Treated With Bioajusta X Orthodontic Appliance - Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01164631
- Acronym / sponsor ID
- FAPESP - 06/57695-7
- Conditions
- Sleep Apnea Syndrome, Malocclusion
- Keywords
- Sleep Apnea Syndrome, Orthodontics, Tonsillectomy, Child
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Nov 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 16 Jul 2010 (estimated)
- 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.
Enlarged tonsils and malocclusion have relationship with sleep disturbance in children. The consequences of these features can include deviation of normal craniofacial growth such that this may result in a facial morphology more suitable to the development of sleep apnea later in life. The aim of this study was to compare the growth redirection, the evolution of respiratory symptoms and the pharyngeal size of snoring children with obstructive tonsils from the waiting list for surgery treated with the Bioajusta X orthodontic appliance.This new protocol of orthodontic treatment promotes maxillary expansion, mandibular advancement and proper tongue positioning on swallowing , that together may be helpful on remodeling the upper airways.
Detailed description
Methods-The study population included 40 children, ranging in age from 6 to 9 years old, who were on the waiting list for adenotonsillectomy at the ENT Department of FMUSP. The patients were randomly divided into two groups and were subsequently compared after a six month interval. The first group included 24 patients who where treated with the Bioajusta X appliance and the second group included 16 patients who served as controls, and,thus, did not received any treatment. Cephalometric analysis was used to assess the growth direction by comparing the relationship of the vertical jaw based upon the angle of the palatal plane with the mandibular plane (ANS-PNS/Go-M).Pharyngeal size was measured using acoustic pharyngometry. The parents filled out a questionnaire with respect to the respiratory symptoms of their children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orthodontic treatment | Experimental | Device: Bioajusta X Orthodontic treatmentSnoring patients enrolling for tonsil surgery with maxillary constriction, and/or jaw retrognathism |
| Control Group | No intervention | –Patients enrolled for tonsils surgery |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children 6 to 9 years of age with tonsils degree 3 or 4 ,
- Sleep snores and narrow maxilla or class II malocclusion.
Key exclusion criteria (3 listed)
- Neurological diseases,
- Tooth missing ,
- Previous orthodontic treatment.
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 |
|---|---|---|
| Bioajusta X Orthodontic treatmentAlso: Oral appliance, Orthodontic Treatment, Orofacial OrthopedicsOral Appliance that promotes semi-rapid maxillary expansion, while corrects tongue positioning and jaws relationship | Device | Orthodontic treatment |
Primary outcome
Evaluation of the facial growth
Time frame: six months
Facial X rays exams were measured from both groups (treatment and control) and compared in a six month interval, in respect to sleep apnea predictors
1 secondary outcome
Pharyngeal Size
Time frame: six month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2012.
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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.
Renata C Di Francesco, Phd study director
University of Sao Paulo General Hospital
Walter R Nunes Jr., Ms principal investigator
University of Sao Paulo
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bioajusta X Orthodontic treatment in people with Sleep Apnea Syndrome and Malocclusion, run by University of Sao Paulo General Hospital.
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 2 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: finished, as of the sponsor's last update on 22 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the facial growth (time frame: six months). 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 22 Jun 2012.