OSAHSOSAHSNCT04301635
Upper-airway Changes After Bimaxillary Advancement in OSAHS
An observational study of OSAHS and Craniofacial Abnormalities, run by Hospital de Cruces at 1 site in Spain.
Trial summary
One of the most effective surgical treatments for obstructive sleep apnoea / hypopnoea syndrome (SAHS) with global impact on the upper-airway (UA) is the maxilla-mandibular advancement (MMA). Retrospective-prospective observational study of: clinical outcomes, UA and dental-cranium-facial (DCF) morphology. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- OSAHS, Craniofacial Abnormalities
- What is being tested?
- Maxillo-mandibular Advancement + Counterclockwise rotation
- Type of treatment
- Surgery or procedure
- How many people
- 38 participants
- Where
- 1 siteSpain
- Study dates
- 4 Feb 2019to 30 Nov 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients treated in a single centre: Maxillofacial Surgery department, "Hospital de Cruces", Barakaldo, Spain Time period from 01/01/2012 to 01/31/2019.
Who may be able to join
- ≥18 years-old.
- Diagnosis by polysomnography of moderate-severe obstructive sleep apnoea / hypopnoea syndrome (SAHS) in supine position.
- Approval of the surgical indication by the multidisciplinary sleep committee of our hospital
- Written informed consent (IC) of photography or image recording, orthognathic surgery program inclusion and facial deformity surgery.
- Specific IC for inclusion in the present study.
Who cannot join
- Pregnant woman
- Central SAHS
- Medical-surgical history that significantly alter the normal upper-airway anatomy: trauma, tumour, major congenital craniofacial deformity
- Different orthognathic surgery than MMA
- Inconclusive / incomplete tests and data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Upper-airway Changes After Bimaxillary Advancement in Moderate-severe Obstructive Sleep Apnoea / Hypopnoea Syndrome
One of the most effective surgical treatments for obstructive sleep apnoea / hypopnoea syndrome (SAHS) with global impact on the upper-airway (UA) is the maxilla-mandibular advancement (MMA). Retrospective-prospective observational study of: clinical outcomes, UA and dental-cranium-facial (DCF) morphology.
Population sample will be patients treated in the Maxillofacial Surgery department of "Hospital de Cruces". As inclusion criteria: ≥18 years-old, moderate-severe SAHS in supine position, multidisciplinary committee of sleep pathology evaluation for surgical indication, and written informed consents. As exclusion criteria: pregnant woman, SAHS of central origin, cranium-facial deformities that significantly modify normal UA, different surgery than MMA and inconclusive / incomplete tests. It is estimated ≥90% males; ≥90% 30-59 years-old; ≤10% extreme weights; 25% complementary surgeries; and sample size 40. Medical ethics code of the Declaration of Helsinki will be taken into account. To collect the pre- / postoperative data we will use, calibrated and standardized: polysomnography (PSG), computed tomography (CT), right face profile picture (RFP) and lateral teleradiography of the cranium (LTC). Furthermore, the Epworth scale and non-validated subjective self-perception test of facial aesthetics will be performed.
Clinical outcomes will be evaluated from PSG using apnoea / hypopnoea index and pulse oximeter oxygen saturation, and from Epworth scale. UA morphology from CT, globally and by specific locations, through lengths, volumes, areas, dimensions, and other measurements. DCF aspects from RFP and LTC, by Ricketts cephalometric basic analysis and facial aesthetics test. Statistical, descriptive analysis of frequencies and comparative by pairs of quantitative data will be by t-Student or Wilcoxon test, after checking the variables normality with the Kolmogorov-Smirnov test.
Read the detailed description
HYPOTHESIS:
H0: Upper-airway (UA) morphology does not change as a consequence of maxilla-mandibular advancement (MMA) in patients with moderate-severe obstructive sleep apnoea / hypopnoea syndrome (SAHS).
H1: UA changes as a consequence of MMA in patients with moderate-severe SAHS. To answer this hypothesis, the following will be determined: Vertical UA length, volume, axial areas, ellipticity, uniformity, prevertebral soft tissue (PST) and soft palate (SP) lengths and position of the hyoid bone.
As secondary hypotheses:
H0: Clinical outcomes of MMA in moderate-severe SAHS are not successful. H1: Clinical outcomes of MMA in moderate-severe SAHS are successful. To answer, the apnoea / hypopnoea index (AHI), pulse oximeter oxygen saturation (SPO2) and daytime sleepiness will be determined.
H0: DCF morphology is unfavourable as a result of MMA in moderate-severe SAHS. H1: DCF morphology is not unfavourable as a result of MMA in moderate-severe SAHS.
To answer, the parameters of the Ricketts cephalometric basic analysis will be quantified and interpreted, and the patient's self-perception will be assessed.
OBJECTIVES:
Specify and quantify morphological changes in key anatomical locations of the UA by computed tomography (CT), in terms of vertical lengths, volumes, areas, axial dimensions, and other measurements. These changes happen after MMA surgery in patients diagnosed with moderate-severe SAHS from a representative cohort. We are intended to demonstrate: shortening, increase in volume and areas, more elliptical and uniform shape, modifications of PST and SP and more anterior-superior hyoid bone position.
As secondary objectives, inherent to the treatment received, it is first intended to determine and evaluate clinical outcomes: objectively by polysomnography, and subjectively by the Epworth scale. Secondary, it is intended to specify and quantify changes in DCF morphology: objectively by a two-dimensional cephalometric analysis from lateral teleradiography of the cranium (LTC) and right face profile picture (RFP), and subjectively by a non-validated facial aesthetics test (FAT).
DESIGN:
Observational retrospective-prospective study, which does not make any modification of the usual clinical practice (surgical indication criteria, procedures, examinations, surgical techniques...), of: clinical outcomes, UA morphology, and DCF aspects of SAHS patients undergoing MMA.
- Logistic and organizational process for the participants: Explanations, invitation to participate, resolution of doubts, delivery of written information sheet and informed consent, collection of them and FAT. Everything will be done in two face-to-face clinic consultations that are already part of the usual work protocol of the Maxillofacial Surgery department of our hospital for patients with SAHS. It is estimated that it only involves about 10-15 minutes per consultation of extra time, without the need of additional specific appointments for the present study. With regard to clinical history, complementary examinations and surgical procedure, nothing additional is required regarding the usual workflow for SAHS patients in our department.
- Logistic and organizational process for researchers: It is based on office and digital work, without biological samples.
A sample size of 40 subjects is estimated, compiling previous studies and the Granmo® calculator. This would achieve significant statistics in all the parameters considered to answer the main hypothesis, and most of the secondary ones.
The Declaration of Helsinki code of medical ethics for research in human beings will be taken into account, protecting the health of the participant, being voluntary the inclusion, interrupting the investigation if it can be detrimental to the well-being of the participant and agreement of confidentiality in the IC. The "CEIC OSI Exkerraldea-Enkarterri-Cruces" committee has approved the study (Code CEIC E19/39).
DATA ANALYSIS:
We will analyze the qualitative and continuous quantitative variables in categorical variables. Descriptive statistics of frequencies will be calculated. For statistical inference, only comparisons are made between two continuous variables, all dependent and paired (pre- / post-). To verify that the variables follow a normal distribution, the Kolmogorov-Smirnov statistic will be used. The comparisons will then be made with the t-Student test for two dependent samples or the Wilcoxon ranks test if they do not follow a normal distribution. Statistically significant results will be considered if p ˂0.05.
- Conditions
- OSAHS, Craniofacial Abnormalities
- Being tested
- Maxillo-mandibular Advancement + Counterclockwise rotation
- Keywords
- OSAHS, Sleep disorder, Orthognathic surgery, Maxillomandibular advancement, Counterclockwise rotation
- Medical subject headings
- Sleep Apnea, Obstructive, Craniofacial Abnormalities, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxillo-mandibular Advancement + Counterclockwise rotationProcedure or surgery
Also called Bimaxillary Advancement, Orthognathic Surgery
Maxilla: Lefort I osteotomy Mandible: Obwegeser-Dal-Pont osteotomy Movements: Advance and counterclockwise rotation
| Study group | Role | What they receive |
|---|---|---|
| Preoperative (Pre-) | Moderate-severe obstructive sleep apnoea / hypopnoea patients, preoperative Receives: Procedure: Maxillo-mandibular Advancement + Counterclockwise rotation | |
| Postoperative (Post-) | Moderate-severe obstructive sleep apnoea / hypopnoea patients, postoperative Receives: Procedure: Maxillo-mandibular Advancement + Counterclockwise rotation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper-airway morphology: Vertical length
From computed-tomography examinations. Total, retropalatal compartment, retro-glossal compartment, hypopharynx compartment and summatory. Measured in mm.
Measured: Through study completion, an average of 1 year
Upper-airway morphology: volume
From computed-tomography examinations. Total, retropalatal compartment, retro-glossal compartment, hypopharynx compartment and summatory. Measured in mm^3.
Measured: Through study completion, an average of 1 year
Upper-airway morphology: area
From computed-tomography examinations. Minimum, hard palate plane, parallel uvula tip plane, parallel epiglottis tip plane, parallel inferior edge of the hyoid bone plane. Measured in mm. Measured in mm^2.
Measured: Through study completion, an average of 1 year
Upper-airway morphology: ellipticity
A formula: transversal dimension / anteroposterior dimension. Dimensions characteristics are: From computed-tomography examinations. Minimum, hard palate plane, parallel uvula tip plane, parallel epiglottis tip plane, parallel inferior edge of the hyoid bone plane. Measured in mm.
Measured: Through study completion, an average of 1 year
Upper-airway morphology: uniformity
A formula: minimum area / (hard palate area + uvula tip area + epiglottis tip area + hyoid bone area) Measured in units from 0 to 1.
Measured: Through study completion, an average of 1 year
Upper-airway morphology: prevertebral soft tissue length
From computed-tomography examinations. Measured in mm.
Measured: Through study completion, an average of 1 year
Upper-airway morphology: soft palate length
From computed-tomography examinations. Measured in mm.
Measured: Through study completion, an average of 1 year
Upper-airway morphology: position of the hyoid bone
From computed-tomography examinations. Measured in mm in the anteroposterior aspect and also the superoinferior aspect, this one is the same measure as vertical length.
Measured: Through study completion, an average of 1 year
Secondary outcomes (22)
Clinical outcomes: Apnoea / hypopnoea index
From polysomnography records. Global, in supine position and in lateral position. Measured in units from 0 to 100.
Measured: Through study completion, an average of 1 year
Clinical outcomes: pulse oximeter oxygen saturation.
From polysomnography records. Mean, basal and minimum. Measured in %.
Measured: Through study completion, an average of 1 year
Clinical outcomes: daytime sleepiness
From the Epworth scale. Measured in units from 0 to 24.
Measured: Through study completion, an average of 1 year
Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: facial axis angle
From lateral teleradiography of the cranium and right facial profile photography. Measured in grades.
Measured: Through study completion, an average of 1 year
Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: facial depth
From lateral teleradiography of the cranium and right facial profile photography. Measured in grades.
Measured: Through study completion, an average of 1 year
Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: mandibular plane angle
From lateral teleradiography of the cranium and right facial profile photography. Measured in grades.
Measured: Through study completion, an average of 1 year
Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: lower facial height
From lateral teleradiography of the cranium and right facial profile photography. Measured in mm.
Measured: Through study completion, an average of 1 year
Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: mandibular arch
From lateral teleradiography of the cranium and right facial profile photography. Measured in grades.
Measured: Through study completion, an average of 1 year
Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: facial convexity
From lateral teleradiography of the cranium and right facial profile photography. Measured in mm.
Measured: Through study completion, an average of 1 year
Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: maxillary depth
From lateral teleradiography of the cranium and right facial profile photography. Measured in grades
Measured: Through study completion, an average of 1 year
Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: incisor protrusion
From lateral teleradiography of the cranium and right facial profile photography. Measured in mm.
Measured: Through study completion, an average of 1 year
Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: incisor inclination
From lateral teleradiography of the cranium and right facial profile photography. Measured in grades.
Measured: Through study completion, an average of 1 year
Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: incisor extrusion
From lateral teleradiography of the cranium and right facial profile photography. Measured in mm.
Measured: Through study completion, an average of 1 year
Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: interincisal angle
From lateral teleradiography of the cranium and right facial profile photography. Measured in grades.
Measured: Through study completion, an average of 1 year
Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: upper molar position
From lateral teleradiography of the cranium and right facial profile photography. Measured in mm.
Measured: Through study completion, an average of 1 year
Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: labial protrusion
From lateral teleradiography of the cranium and right facial profile photography. Measured in mm.
Measured: Through study completion, an average of 1 year
Dental-cranium-facial morphology: non-validated facial aesthetics test: general satisfaction
Qualitative measurement: none, little, ok, a lot of.
Measured: Through study completion, an average of 1 year
Dental-cranium-facial morphology: non-validated facial aesthetics test: modifications perceived by the patient
Qualitative measurement: much worse, worse, no changes, better, much better.
Measured: Through study completion, an average of 1 year
Dental-cranium-facial morphology: non-validated facial aesthetics test: modifications perceived by family members and friends
Qualitative measurement: much worse, worse, no changes, better, much better.
Measured: Through study completion, an average of 1 year
Dental-cranium-facial morphology: non-validated facial aesthetics test: smile
Qualitative measurement: much worse, worse, no changes, better, much better.
Measured: Through study completion, an average of 1 year
Dental-cranium-facial morphology: non-validated facial aesthetics test: face rejuvenation
Qualitative measurement: older, no changes, younger.
Measured: Through study completion, an average of 1 year
Dental-cranium-facial morphology: non-validated facial aesthetics test: face slimness
Qualitative measurement: bulkier, no changes, slimmer.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start4 Feb 2019
- Primary completion31 Dec 2019
- Study completion30 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OSAHSStudies 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
- Other
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Cruces
- Sponsor type
- University, hospital or other
- Collaborators
- University of the Basque Country (UPV/EHU), Biobizkaia Health Research Institute
- Responsible party
- Principal investigator, Carlos Prol Teijeiro, Hospital de Cruces
- Investigators
- Carlos Prol, Mr, Principal investigator, Osakidetza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04301635
- Sponsor's protocol ID
- SAHS_PROL
- Acronym
- OSAHS
- Status last verified
- Feb 2021
- First submitted
- 4 Mar 2020
- Last updated
- 10 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: General non-identifying subjects data Upper-airway morphology data Clinical outcomes data Dental-cranium-facial morphology data
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upper-airway Changes After Bimaxillary Advancement in Moderate-severe Obstructive Sleep Apnoea / Hypopnoea Syndrome
- ClinicalTrials.gov ID
- NCT04301635
- Acronym / sponsor ID
- OSAHS / SAHS_PROL
- Conditions
- OSAHS, Craniofacial Abnormalities
- Keywords
- OSAHS, Sleep disorder, Orthognathic surgery, Maxillomandibular advancement, Counterclockwise rotation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Hospital de CrucesUniversity, hospital or other
- Collaborators
- University of the Basque Country (UPV/EHU), Biobizkaia Health Research Institute
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 10 Mar 2020 (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.
One of the most effective surgical treatments for obstructive sleep apnoea / hypopnoea syndrome (SAHS) with global impact on the upper-airway (UA) is the maxilla-mandibular advancement (MMA). Retrospective-prospective observational study of: clinical outcomes, UA and dental-cranium-facial (DCF) morphology.
Population sample will be patients treated in the Maxillofacial Surgery department of "Hospital de Cruces". As inclusion criteria: ≥18 years-old, moderate-severe SAHS in supine position, multidisciplinary committee of sleep pathology evaluation for surgical indication, and written informed consents. As exclusion criteria: pregnant woman, SAHS of central origin, cranium-facial deformities that significantly modify normal UA, different surgery than MMA and inconclusive / incomplete tests. It is estimated ≥90% males; ≥90% 30-59 years-old; ≤10% extreme weights; 25% complementary surgeries; and sample size 40. Medical ethics code of the Declaration of Helsinki will be taken into account. To collect the pre- / postoperative data we will use, calibrated and standardized: polysomnography (PSG), computed tomography (CT), right face profile picture (RFP) and lateral teleradiography of the cranium (LTC). Furthermore, the Epworth scale and non-validated subjective self-perception test of facial aesthetics will be performed.
Clinical outcomes will be evaluated from PSG using apnoea / hypopnoea index and pulse oximeter oxygen saturation, and from Epworth scale. UA morphology from CT, globally and by specific locations, through lengths, volumes, areas, dimensions, and other measurements. DCF aspects from RFP and LTC, by Ricketts cephalometric basic analysis and facial aesthetics test. Statistical, descriptive analysis of frequencies and comparative by pairs of quantitative data will be by t-Student or Wilcoxon test, after checking the variables normality with the Kolmogorov-Smirnov test.
Detailed description
HYPOTHESIS:
H0: Upper-airway (UA) morphology does not change as a consequence of maxilla-mandibular advancement (MMA) in patients with moderate-severe obstructive sleep apnoea / hypopnoea syndrome (SAHS).
H1: UA changes as a consequence of MMA in patients with moderate-severe SAHS. To answer this hypothesis, the following will be determined: Vertical UA length, volume, axial areas, ellipticity, uniformity, prevertebral soft tissue (PST) and soft palate (SP) lengths and position of the hyoid bone.
As secondary hypotheses:
H0: Clinical outcomes of MMA in moderate-severe SAHS are not successful. H1: Clinical outcomes of MMA in moderate-severe SAHS are successful. To answer, the apnoea / hypopnoea index (AHI), pulse oximeter oxygen saturation (SPO2) and daytime sleepiness will be determined.
H0: DCF morphology is unfavourable as a result of MMA in moderate-severe SAHS. H1: DCF morphology is not unfavourable as a result of MMA in moderate-severe SAHS.
To answer, the parameters of the Ricketts cephalometric basic analysis will be quantified and interpreted, and the patient's self-perception will be assessed.
OBJECTIVES:
Specify and quantify morphological changes in key anatomical locations of the UA by computed tomography (CT), in terms of vertical lengths, volumes, areas, axial dimensions, and other measurements. These changes happen after MMA surgery in patients diagnosed with moderate-severe SAHS from a representative cohort. We are intended to demonstrate: shortening, increase in volume and areas, more elliptical and uniform shape, modifications of PST and SP and more anterior-superior hyoid bone position.
As secondary objectives, inherent to the treatment received, it is first intended to determine and evaluate clinical outcomes: objectively by polysomnography, and subjectively by the Epworth scale. Secondary, it is intended to specify and quantify changes in DCF morphology: objectively by a two-dimensional cephalometric analysis from lateral teleradiography of the cranium (LTC) and right face profile picture (RFP), and subjectively by a non-validated facial aesthetics test (FAT).
DESIGN:
Observational retrospective-prospective study, which does not make any modification of the usual clinical practice (surgical indication criteria, procedures, examinations, surgical techniques...), of: clinical outcomes, UA morphology, and DCF aspects of SAHS patients undergoing MMA.
- Logistic and organizational process for the participants: Explanations, invitation to participate, resolution of doubts, delivery of written information sheet and informed consent, collection of them and FAT. Everything will be done in two face-to-face clinic consultations that are already part of the usual work protocol of the Maxillofacial Surgery department of our hospital for patients with SAHS. It is estimated that it only involves about 10-15 minutes per consultation of extra time, without the need of additional specific appointments for the present study. With regard to clinical history, complementary examinations and surgical procedure, nothing additional is required regarding the usual workflow for SAHS patients in our department.
- Logistic and organizational process for researchers: It is based on office and digital work, without biological samples.
A sample size of 40 subjects is estimated, compiling previous studies and the Granmo® calculator. This would achieve significant statistics in all the parameters considered to answer the main hypothesis, and most of the secondary ones.
The Declaration of Helsinki code of medical ethics for research in human beings will be taken into account, protecting the health of the participant, being voluntary the inclusion, interrupting the investigation if it can be detrimental to the well-being of the participant and agreement of confidentiality in the IC. The "CEIC OSI Exkerraldea-Enkarterri-Cruces" committee has approved the study (Code CEIC E19/39).
DATA ANALYSIS:
We will analyze the qualitative and continuous quantitative variables in categorical variables. Descriptive statistics of frequencies will be calculated. For statistical inference, only comparisons are made between two continuous variables, all dependent and paired (pre- / post-). To verify that the variables follow a normal distribution, the Kolmogorov-Smirnov statistic will be used. The comparisons will then be made with the t-Student test for two dependent samples or the Wilcoxon ranks test if they do not follow a normal distribution. Statistically significant results will be considered if p ˂0.05.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative (Pre-) | – | Procedure: Maxillo-mandibular Advancement + Counterclockwise rotationModerate-severe obstructive sleep apnoea / hypopnoea patients, preoperative |
| Postoperative (Post-) | – | Procedure: Maxillo-mandibular Advancement + Counterclockwise rotationModerate-severe obstructive sleep apnoea / hypopnoea patients, postoperative |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients treated in a single centre: Maxillofacial Surgery department, "Hospital de Cruces", Barakaldo, Spain Time period from 01/01/2012 to 01/31/2019.
Key inclusion criteria (5 listed)
- ≥18 years-old.
- Diagnosis by polysomnography of moderate-severe obstructive sleep apnoea / hypopnoea syndrome (SAHS) in supine position.
- Approval of the surgical indication by the multidisciplinary sleep committee of our hospital
- Written informed consent (IC) of photography or image recording, orthognathic surgery program inclusion and facial deformity surgery.
- Specific IC for inclusion in the present study.
Key exclusion criteria (5 listed)
- Pregnant woman
- Central SAHS
- Medical-surgical history that significantly alter the normal upper-airway anatomy: trauma, tumour, major congenital craniofacial deformity
- Different orthognathic surgery than MMA
- Inconclusive / incomplete tests and data.
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 |
|---|---|---|
| Maxillo-mandibular Advancement + Counterclockwise rotationAlso: Bimaxillary Advancement, Orthognathic SurgeryMaxilla: Lefort I osteotomy Mandible: Obwegeser-Dal-Pont osteotomy Movements: Advance and counterclockwise rotation | Procedure or surgery | Postoperative (Post-), Preoperative (Pre-) |
Primary outcome
Upper-airway morphology: Vertical length
Time frame: Through study completion, an average of 1 year
From computed-tomography examinations. Total, retropalatal compartment, retro-glossal compartment, hypopharynx compartment and summatory. Measured in mm.
Upper-airway morphology: volume
Time frame: Through study completion, an average of 1 year
From computed-tomography examinations. Total, retropalatal compartment, retro-glossal compartment, hypopharynx compartment and summatory. Measured in mm^3.
Upper-airway morphology: area
Time frame: Through study completion, an average of 1 year
From computed-tomography examinations. Minimum, hard palate plane, parallel uvula tip plane, parallel epiglottis tip plane, parallel inferior edge of the hyoid bone plane. Measured in mm. Measured in mm^2.
Upper-airway morphology: ellipticity
Time frame: Through study completion, an average of 1 year
A formula: transversal dimension / anteroposterior dimension. Dimensions characteristics are: From computed-tomography examinations. Minimum, hard palate plane, parallel uvula tip plane, parallel epiglottis tip plane, parallel inferior edge of the hyoid bone plane. Measured in mm.
Upper-airway morphology: uniformity
Time frame: Through study completion, an average of 1 year
A formula: minimum area / (hard palate area + uvula tip area + epiglottis tip area + hyoid bone area) Measured in units from 0 to 1.
Upper-airway morphology: prevertebral soft tissue length
Time frame: Through study completion, an average of 1 year
From computed-tomography examinations. Measured in mm.
Upper-airway morphology: soft palate length
Time frame: Through study completion, an average of 1 year
From computed-tomography examinations. Measured in mm.
Upper-airway morphology: position of the hyoid bone
Time frame: Through study completion, an average of 1 year
From computed-tomography examinations. Measured in mm in the anteroposterior aspect and also the superoinferior aspect, this one is the same measure as vertical length.
22 secondary outcomes
Clinical outcomes: Apnoea / hypopnoea index
Time frame: Through study completion, an average of 1 year
Clinical outcomes: pulse oximeter oxygen saturation.
Time frame: Through study completion, an average of 1 year
Clinical outcomes: daytime sleepiness
Time frame: Through study completion, an average of 1 year
Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: facial axis angle
Time frame: Through study completion, an average of 1 year
Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: facial depth
Time frame: Through study completion, an average of 1 year
Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: mandibular plane angle
Time frame: Through study completion, an average of 1 year
Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: lower facial height
Time frame: Through study completion, an average of 1 year
Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: mandibular arch
Time frame: Through study completion, an average of 1 year
Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: facial convexity
Time frame: Through study completion, an average of 1 year
Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: maxillary depth
Time frame: Through study completion, an average of 1 year
Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: incisor protrusion
Time frame: Through study completion, an average of 1 year
Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: incisor inclination
Time frame: Through study completion, an average of 1 year
Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: incisor extrusion
Time frame: Through study completion, an average of 1 year
Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: interincisal angle
Time frame: Through study completion, an average of 1 year
Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: upper molar position
Time frame: Through study completion, an average of 1 year
Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: labial protrusion
Time frame: Through study completion, an average of 1 year
Dental-cranium-facial morphology: non-validated facial aesthetics test: general satisfaction
Time frame: Through study completion, an average of 1 year
Dental-cranium-facial morphology: non-validated facial aesthetics test: modifications perceived by the patient
Time frame: Through study completion, an average of 1 year
Dental-cranium-facial morphology: non-validated facial aesthetics test: modifications perceived by family members and friends
Time frame: Through study completion, an average of 1 year
Dental-cranium-facial morphology: non-validated facial aesthetics test: smile
Time frame: Through study completion, an average of 1 year
Dental-cranium-facial morphology: non-validated facial aesthetics test: face rejuvenation
Time frame: Through study completion, an average of 1 year
Dental-cranium-facial morphology: non-validated facial aesthetics test: face slimness
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
- Individual participant dataSharing planned: Undecided. General non-identifying subjects data Upper-airway morphology data Clinical outcomes data Dental-cranium-facial morphology data
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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.
Carlos Prol, Mr principal investigator
Osakidetza
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 OSAHS and Craniofacial Abnormalities, run by Hospital de Cruces at 1 site in Spain.
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 5 inclusion and 5 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 10 Feb 2021. 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 Spain. 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?
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?
Upper-airway morphology: Vertical length (time frame: Through study completion, an average of 1 year). The study lists 8 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 10 Feb 2021; AzTrials last refreshed its copy on 6 Nov 2026.