Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Upper-airway morphology: Vertical length |
From computed-tomography examinations. Total, retropalatal compartment, retro-glossal compartment, hypopharynx compartment and summatory. Measured in mm. |
Through study completion, an average of 1 year |
|
Primary |
Upper-airway morphology: volume |
From computed-tomography examinations. Total, retropalatal compartment, retro-glossal compartment, hypopharynx compartment and summatory. Measured in mm^3. |
Through study completion, an average of 1 year |
|
Primary |
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. |
Through study completion, an average of 1 year |
|
Primary |
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. |
Through study completion, an average of 1 year |
|
Primary |
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. |
Through study completion, an average of 1 year |
|
Primary |
Upper-airway morphology: prevertebral soft tissue length |
From computed-tomography examinations. Measured in mm. |
Through study completion, an average of 1 year |
|
Primary |
Upper-airway morphology: soft palate length |
From computed-tomography examinations. Measured in mm. |
Through study completion, an average of 1 year |
|
Primary |
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. |
Through study completion, an average of 1 year |
|
Secondary |
Clinical outcomes: Apnoea / hypopnoea index |
From polysomnography records. Global, in supine position and in lateral position. Measured in units from 0 to 100. |
Through study completion, an average of 1 year |
|
Secondary |
Clinical outcomes: pulse oximeter oxygen saturation. |
From polysomnography records. Mean, basal and minimum. Measured in %. |
Through study completion, an average of 1 year |
|
Secondary |
Clinical outcomes: daytime sleepiness |
From the Epworth scale. Measured in units from 0 to 24. |
Through study completion, an average of 1 year |
|
Secondary |
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. |
Through study completion, an average of 1 year |
|
Secondary |
Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: facial depth |
From lateral teleradiography of the cranium and right facial profile photography. Measured in grades. |
Through study completion, an average of 1 year |
|
Secondary |
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. |
Through study completion, an average of 1 year |
|
Secondary |
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. |
Through study completion, an average of 1 year |
|
Secondary |
Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: mandibular arch |
From lateral teleradiography of the cranium and right facial profile photography. Measured in grades. |
Through study completion, an average of 1 year |
|
Secondary |
Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: facial convexity |
From lateral teleradiography of the cranium and right facial profile photography. Measured in mm. |
Through study completion, an average of 1 year |
|
Secondary |
Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: maxillary depth |
From lateral teleradiography of the cranium and right facial profile photography. Measured in grades |
Through study completion, an average of 1 year |
|
Secondary |
Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: incisor protrusion |
From lateral teleradiography of the cranium and right facial profile photography. Measured in mm. |
Through study completion, an average of 1 year |
|
Secondary |
Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: incisor inclination |
From lateral teleradiography of the cranium and right facial profile photography. Measured in grades. |
Through study completion, an average of 1 year |
|
Secondary |
Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: incisor extrusion |
From lateral teleradiography of the cranium and right facial profile photography. Measured in mm. |
Through study completion, an average of 1 year |
|
Secondary |
Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: interincisal angle |
From lateral teleradiography of the cranium and right facial profile photography. Measured in grades. |
Through study completion, an average of 1 year |
|
Secondary |
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. |
Through study completion, an average of 1 year |
|
Secondary |
Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: labial protrusion |
From lateral teleradiography of the cranium and right facial profile photography. Measured in mm. |
Through study completion, an average of 1 year |
|
Secondary |
Dental-cranium-facial morphology: non-validated facial aesthetics test: general satisfaction |
Qualitative measurement: none, little, ok, a lot of. |
Through study completion, an average of 1 year |
|
Secondary |
Dental-cranium-facial morphology: non-validated facial aesthetics test: modifications perceived by the patient |
Qualitative measurement: much worse, worse, no changes, better, much better. |
Through study completion, an average of 1 year |
|
Secondary |
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. |
Through study completion, an average of 1 year |
|
Secondary |
Dental-cranium-facial morphology: non-validated facial aesthetics test: smile |
Qualitative measurement: much worse, worse, no changes, better, much better. |
Through study completion, an average of 1 year |
|
Secondary |
Dental-cranium-facial morphology: non-validated facial aesthetics test: face rejuvenation |
Qualitative measurement: older, no changes, younger. |
Through study completion, an average of 1 year |
|
Secondary |
Dental-cranium-facial morphology: non-validated facial aesthetics test: face slimness |
Qualitative measurement: bulkier, no changes, slimmer. |
Through study completion, an average of 1 year |
|