Sleep Apnea, ObstructiveNCT05677620
Predictive Factors for Prescribing a Mandibular Advancement Device for the Treatment of Obstructive Sleep Apnea
An observational study of Sleep Apnea, Obstructive, run by Egas Moniz - Cooperativa de Ensino Superior, CRL at 1 site in Portugal.
Trial summary
This project evaluates the morphological predictive factors for prescribing a mandibular advancement device in the therapeutic approach of Obstructive sleep apnea (OSA). The investigators will carry out the project with patients who travel to CUF Tejo Hospital to solve their sleep disturbance, namely cases of… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- Pharyngeal Computed Tomography, Drug-Induced Sleep Endoscopy (Propofol) and Mandibular Advancement Device
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device, Surgery or procedure
- How many people
- 66 participants
- Where
- 1 sitePortugal
- Study dates
- Mar 2023to Dec 2023
- How long will I take part?
- 6 Months
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study will present 66 adult patients diagnosed with mild or moderate OSAS (5 <AHI ≤ 30/h) through polysomnography (PSG) level III, referred from pulmonology, otorhinolaryngology and/or neurology for treatment with ADM, who refuse or do not tolerate the therapeutic approach of CPAP, in the sleep unit of Hospital CUF Tejo.
Who may be able to join
- Patients between 18 and 70 years of age with the indication for treatment with mandibular advancement device, who refused or cannot tolerate CPAP;
- Body Mass Index (BMI) between 19 and 34.9 Kg/m2;
- The presence of 8 healthy teeth or more per jaw (upper and lower );
- Maximum mandibular protrusion capacity of at least 6 mm.
Who cannot join
- Significant nasal obstruction; chronic lung disease;
- Class III or IV congestive heart failure according to the New York Heart Association classification;
- Neuromuscular diseases or previous upper airway surgery unrelated to obstructive sleep apnea;
- Uncontrolled periodontitis;
- Tooth mobility;
- Orthodontic treatment;
- Dental prosthesis wholly or partially removable.
Trial locations and contacts
1 site in 1 country.
Portugal1 site
CUF Tejo Hospital
Lisbon, 1350-352
Cristina Caroça, PhD, 917507165 ext. +351, cristinacaroca@icloud.com
About this study
Official title: Predictive Morphological Factors for Prescribing a Mandibular Advancement Device in the Therapeutic Approach of Obstructive Sleep Apnea
This project evaluates the morphological predictive factors for prescribing a mandibular advancement device in the therapeutic approach of Obstructive sleep apnea (OSA). The investigators will carry out the project with patients who travel to CUF Tejo Hospital to solve their sleep disturbance, namely cases of obstructive sleep apnea. The investigators designed three groups of 22 individuals each. The investigators will only include individuals after signing the informed consent. In the 1st appointment, the principal investigator will conduct a complete anamnesis and a clinical examination, where several items will be documented: Age, gender, body mass index, mallampati index, neck, and waist circumference. The clinical interview will assess the patient's daytime sleepiness, nighttime snoring, and quality of life through the respective questionnaires: the Epworth Sleepiness Scale (ESS), the snoring severity scale (SSS), and the Sleep Apnea Quality of Life Index (SAQLI). Still, in the 1st consultation, a level III Polysomnography (PSG) will be prescribed to assess the possibility of OSA, and a pharyngeal computed tomography (CT) with cephalometric analysis and recording in maximum comfortable protrusion to evaluate the Upper Airway (UA) and the prognosis of mandibular advancement in case of UA collapse. The other group will perform Drug-Induced Sleep Endoscopy (DISE) and CT with registration in maximum comfortable protrusion. Then, the investigators will make personalized and titled mandibular advancement devices (MAD). The measurements and PSG III questionnaires will be carried out after 1 and 6 months to evaluate the results.
Read the detailed description
This study will present 66 adult patients diagnosed with mild or moderate OSA (5 <AHI ≤ 30/h) through polysomnography (PSG) level III, referred from pulmonology, otorhinolaryngology and/or neurology for treatment with MAD, who refuse or do not tolerate the therapeutic approach of CPAP, in the sleep unit of Hospital CUF Tejo. The randomization sequence will be generated by computer and kept confidential, in a sealed and opaque envelope, until the moment of recruitment. There will be 3 study groups:
Group A - Will perform pharyngeal CT with cephalometry and registration in maximum comfortable protrusion (MCP).
Group B - Will perform the DISE with registration in MCP. Group C - Will perform pharyngeal CT with cephalometry and recording in MCP + DISE with recording in MCP
In the first appointment, a complete anamnesis and a clinical examination will be carried out, where several items will be documented: Age, gender, BMI, mallampati index, neck, and waist circumference. The clinical interview will assess daytime sleepiness, nighttime snoring, and the patient's quality of life through the respective questionnaires: the Epworth Sleepiness Scale (ESS), the snoring severity scale (SSS), and the Sleep Apnea Quality of Life Index (SAQLI). Using a Likert scale, the ESS is a quantitative assessment tool for drowsiness or the propensity to fall asleep in eight everyday situations. This instrument has been used in various contexts, populations, and clinical conditions, emphasizing sleep-disordered breathing, namely OSA. The SSS is a three-question questionnaire that assesses the intensity, frequency, and duration of snoring, completed by patients and their bed partners. The SSS is internally consistent across patients, regardless of age and sex, and externally valid, as it has a high correlation with the respiratory disturbance index (RDI), AHI, and ESS. The SAQLI was created as a specific quality-of-life instrument for patients with OSAS. This is a 35-item questionnaire that assesses the adverse impact of OSA in four domains: daily animosity, social interactions, emotional state, and symptoms. Items are scored on a 7-point scale. Still, in the 1st consultation, a PSG level III will be prescribed to assess the possibility of OSA and a CT of the pharynx with cephalometric analysis and recording in MCP to assess the UA and the prognosis of advancement of the mandible in the UA collapse/s.
After confirmation of mild to moderate OSA and application of the inclusion and exclusion criteria, patients will be randomly allocated into 3 study groups, with the randomization sequence generated by computer and kept secret in a sealed and opaque envelope until the time of recruitment:
Group A - Will undergo CT of the pharynx with cephalometry and recording in MCP and will be evaluated as a "poor candidate," "candidate with a moderate resolution," or "good candidate." Group B - Will perform the DISE with registration in MCP and will be evaluated as a "bad candidate," "candidate with a moderate resolution," or "good candidate." Group C - Will undergo pharyngeal CT with cephalometry and recording in MCP + DISE with MCP recording and will be evaluated as a "bad candidate," "candidate with a moderate resolution," or "good candidate."
In the second appointment, impressions will be made for the MAD, and in the third appointment, the MAD will be delivered.
After one month of use and adaptation to the MAD, the three groups will perform a PSG level III, in which the patient will have the MAD placed intra-orally, and the ESS, SSS, and SAQLI questionnaires will be filled out again, and the evaluation of adaptation to the MAD will be carried out (self-report).
After six months of using the MAD, the three groups will again perform a PSG level III, in which the patient will have the DAM placed intra-orally in the same mandibular advancement position that was placed in the previous follow-up. The ESS questionnaires will be completed, including SSS, SAQLI, and assessment of adaptation to the MAD (self-report).
The objective treatment outcome will be based on the PSG level III results with the MAD. An effective response to treatment will be defined as a reduction in AHI after treatment with MAD of 50% compared to baseline, and non-response will be described as a reduction in AHI of <50%. For patients who do not present an effective response in the 1st Follow-up (where PSG level III will be performed one month after adaptation to the MAD), the MAD will be titrated (with more significant mandibular advancement) with the aim of, in the 2nd Follow-up up (where PSG level III will be performed six months after adaptation to the MAD) to obtain an adequate response, always thinking about the most significant possible AHI reduction to improve the patient's quality of life. It will also be analyzed whether the assessment during DISE, that the patient is a "good candidate," "candidate with a moderate resolution," and "poor candidate," is effective after PSG with MAD.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- Pharyngeal Computed Tomography, Drug-Induced Sleep Endoscopy (Propofol), Mandibular Advancement Device
- Keywords
- Oral Appliance, DISE, Computed Tomography, Mandibular Advancement Device
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharyngeal Computed TomographyRadiation
Also called Pharyngeal CT
To assess the presence of a possible level/level of collapse, a pharyngeal CT with cephalometry will be performed, and a standard classification system, VOTE, will be used. After obtaining said CT, the dentist will place the recording in MCP and perform a new CT scan of the pharynx with cephalometry and with the MCP recording set intraorally to assess whether this position reduces or eliminates the collapse from UA.
Drug-Induced Sleep Endoscopy (Propofol)Drug
Also called DISE
The DISE technique will be performed by an otorhinolaryngologist (ENT) with a nasopharyngoscope in a operating room. This technique is complemented with bite registration (MCP). Artificial sleep will be induced by intravenous administration of propofol through an infusion system controlled by an anesthesiologist (2.0-3.0 mcg/mL). The following variables will be continuously monitored: electrocardiography, oxygen saturation, and bispectral index (BIS). In this phase of the DISE, the upper airways will be evaluated during sleep with the MCP positioned intra-orally.
Mandibular Advancement DeviceDevice
Also called MAD
A duo-block, titratable, and customized MAD (NOA®; Orthoapnea) will be fitted for each patient who starts treatment with MAD. The MAD consists of two CAD/CAM polyamide intraoral devices (one for the upper and one for the lower arch). The adaptation period takes place over one month. After this adaptation, patients will undergo a new PSG using MAD.
| Study group | Role | What they receive |
|---|---|---|
| Group A - Pharyngeal Computed Tomography Group | 22 randomly selected patients with mild to moderate obstructive sleep apnea will undergo pharyngeal CT with cephalometry and with registration in maximum comfortable protrusion (MCP) Receives: Radiation: Pharyngeal Computed Tomography; Device: Mandibular Advancement Device | |
| Group B - Drug-Induced Sleep Endoscopy Group | 22 randomly selected patients with mild to moderate obstructive sleep apnea will undergo Drug-induced sleep endoscopy with registration in maximum comfortable protrusion (MCP) Receives: Drug: Drug-Induced Sleep Endoscopy (Propofol); Device: Mandibular Advancement Device | |
| Group C - Pharyngeal Computed Tomography and Drug-Induced Sleep Endoscopy Group | 22 randomly selected patients with mild to moderate obstructive sleep apnea will undergo a pharyngeal computed tomography + Drug-induced sleep endoscopy with registration in maximum comfortable protrusion (MCP) Receives: Radiation: Pharyngeal Computed Tomography; Drug: Drug-Induced Sleep Endoscopy (Propofol); Device: Mandibular Advancement Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the apnea-hypopnea index
The apnea-hypopnea index will be registered with the level III polysomnography and we will evaluate after using the MAD if there were improvements or not, relating to the predictors that we analyzed before.
Measured: Before making and starting to use the MAD and one and six months after
Changes in upper airway collapse analyzed by CT Pharyngeal
the prognosis for the use of a MAD using the MCP recording and VOTE scoring system: when the upper airway collapse has entirely resolved (no residual collapse at any level of the upper airway), with the bite registration in MCP, the patient will be considered a "Good Candidate." Suppose there is only partial resolution (improvement, but with the residual or multilevel collapse of the upper airway) with the bite registration in PMC. In that case, you will qualify as a "moderately resolved candidate." If upper airway collapse remains unchanged or worsens with PMC bite registration, patients will be considered a "poor candidate."
Measured: Through study completion, an average of six months
Changes in Upper Airway collapse analyzed by DISE
Evaluation of the prognosis for the use of a MAD, we will use the mandibular advancement record in MCP. The VOTE classification: when the UA collapse is completely resolved (no residual collapse at any level of the upper airway), and there is no snoring, with the bite registration in MCP, the patient will be considered a "Good Candidate." Suppose there is only partial resolution (improvement, but with the residual or multilevel collapse of the UA) and some snoring with the bite registration in MCP. In that case, he will qualify as a "candidate with moderate resolution." If UA collapse remains unchanged or worsens with MCP bite registration and still snoring, patients will be considered a "bad candidate."
Measured: through study completion, an average of six months
Secondary outcomes (2)
Subjective assessment of daytime sleepiness
The subjective evaluation will be done through a validated questionnaire: Epworth Sleepiness Scale (ESS). The ESS asks the respondent to rate on a 4-point scale (0-3). The higher the score, the more severe the daytime sleepiness
Measured: Before making and starting to use the MAD and one and six months after
Subjective assessment of quality of life
The subjective evaluation will be carried out through a validated questionnaire - Sleep Apnea Quality of Life Index (SAQLI) -a 35-item questionnaire that assesses the adverse impact of OSA. Items are scored on a 7-point scale.
Measured: Before making and starting to use the MAD and one and six months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study startMar 2023 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 66 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Egas Moniz - Cooperativa de Ensino Superior, CRL
- Sponsor type
- University, hospital or other
- Collaborators
- CUF Tejo Hospital, Orthoapnea
- Responsible party
- Sponsor
- Investigators
- Cristina Manso, PhD, Study director, Egas Moniz School of Health and Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05677620
- Sponsor's protocol ID
- PHDPMC
- Status last verified
- Feb 2023
- First submitted
- 15 Dec 2022
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Morphological Factors for Prescribing a Mandibular Advancement Device in the Therapeutic Approach of Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT05677620
- Acronym / sponsor ID
- PHDPMC
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Oral Appliance, DISE, Computed Tomography, Mandibular Advancement Device
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Egas Moniz - Cooperativa de Ensino Superior, CRLUniversity, hospital or other
- Collaborators
- CUF Tejo Hospital, Orthoapnea
- Study start
- Mar 2023 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 10 Jan 2023 (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.
This project evaluates the morphological predictive factors for prescribing a mandibular advancement device in the therapeutic approach of Obstructive sleep apnea (OSA). The investigators will carry out the project with patients who travel to CUF Tejo Hospital to solve their sleep disturbance, namely cases of obstructive sleep apnea. The investigators designed three groups of 22 individuals each. The investigators will only include individuals after signing the informed consent. In the 1st appointment, the principal investigator will conduct a complete anamnesis and a clinical examination, where several items will be documented: Age, gender, body mass index, mallampati index, neck, and waist circumference. The clinical interview will assess the patient's daytime sleepiness, nighttime snoring, and quality of life through the respective questionnaires: the Epworth Sleepiness Scale (ESS), the snoring severity scale (SSS), and the Sleep Apnea Quality of Life Index (SAQLI). Still, in the 1st consultation, a level III Polysomnography (PSG) will be prescribed to assess the possibility of OSA, and a pharyngeal computed tomography (CT) with cephalometric analysis and recording in maximum comfortable protrusion to evaluate the Upper Airway (UA) and the prognosis of mandibular advancement in case of UA collapse. The other group will perform Drug-Induced Sleep Endoscopy (DISE) and CT with registration in maximum comfortable protrusion. Then, the investigators will make personalized and titled mandibular advancement devices (MAD). The measurements and PSG III questionnaires will be carried out after 1 and 6 months to evaluate the results.
Detailed description
This study will present 66 adult patients diagnosed with mild or moderate OSA (5 <AHI ≤ 30/h) through polysomnography (PSG) level III, referred from pulmonology, otorhinolaryngology and/or neurology for treatment with MAD, who refuse or do not tolerate the therapeutic approach of CPAP, in the sleep unit of Hospital CUF Tejo. The randomization sequence will be generated by computer and kept confidential, in a sealed and opaque envelope, until the moment of recruitment. There will be 3 study groups:
Group A - Will perform pharyngeal CT with cephalometry and registration in maximum comfortable protrusion (MCP).
Group B - Will perform the DISE with registration in MCP. Group C - Will perform pharyngeal CT with cephalometry and recording in MCP + DISE with recording in MCP
In the first appointment, a complete anamnesis and a clinical examination will be carried out, where several items will be documented: Age, gender, BMI, mallampati index, neck, and waist circumference. The clinical interview will assess daytime sleepiness, nighttime snoring, and the patient's quality of life through the respective questionnaires: the Epworth Sleepiness Scale (ESS), the snoring severity scale (SSS), and the Sleep Apnea Quality of Life Index (SAQLI). Using a Likert scale, the ESS is a quantitative assessment tool for drowsiness or the propensity to fall asleep in eight everyday situations. This instrument has been used in various contexts, populations, and clinical conditions, emphasizing sleep-disordered breathing, namely OSA. The SSS is a three-question questionnaire that assesses the intensity, frequency, and duration of snoring, completed by patients and their bed partners. The SSS is internally consistent across patients, regardless of age and sex, and externally valid, as it has a high correlation with the respiratory disturbance index (RDI), AHI, and ESS. The SAQLI was created as a specific quality-of-life instrument for patients with OSAS. This is a 35-item questionnaire that assesses the adverse impact of OSA in four domains: daily animosity, social interactions, emotional state, and symptoms. Items are scored on a 7-point scale. Still, in the 1st consultation, a PSG level III will be prescribed to assess the possibility of OSA and a CT of the pharynx with cephalometric analysis and recording in MCP to assess the UA and the prognosis of advancement of the mandible in the UA collapse/s.
After confirmation of mild to moderate OSA and application of the inclusion and exclusion criteria, patients will be randomly allocated into 3 study groups, with the randomization sequence generated by computer and kept secret in a sealed and opaque envelope until the time of recruitment:
Group A - Will undergo CT of the pharynx with cephalometry and recording in MCP and will be evaluated as a "poor candidate," "candidate with a moderate resolution," or "good candidate." Group B - Will perform the DISE with registration in MCP and will be evaluated as a "bad candidate," "candidate with a moderate resolution," or "good candidate." Group C - Will undergo pharyngeal CT with cephalometry and recording in MCP + DISE with MCP recording and will be evaluated as a "bad candidate," "candidate with a moderate resolution," or "good candidate."
In the second appointment, impressions will be made for the MAD, and in the third appointment, the MAD will be delivered.
After one month of use and adaptation to the MAD, the three groups will perform a PSG level III, in which the patient will have the MAD placed intra-orally, and the ESS, SSS, and SAQLI questionnaires will be filled out again, and the evaluation of adaptation to the MAD will be carried out (self-report).
After six months of using the MAD, the three groups will again perform a PSG level III, in which the patient will have the DAM placed intra-orally in the same mandibular advancement position that was placed in the previous follow-up. The ESS questionnaires will be completed, including SSS, SAQLI, and assessment of adaptation to the MAD (self-report).
The objective treatment outcome will be based on the PSG level III results with the MAD. An effective response to treatment will be defined as a reduction in AHI after treatment with MAD of 50% compared to baseline, and non-response will be described as a reduction in AHI of <50%. For patients who do not present an effective response in the 1st Follow-up (where PSG level III will be performed one month after adaptation to the MAD), the MAD will be titrated (with more significant mandibular advancement) with the aim of, in the 2nd Follow-up up (where PSG level III will be performed six months after adaptation to the MAD) to obtain an adequate response, always thinking about the most significant possible AHI reduction to improve the patient's quality of life. It will also be analyzed whether the assessment during DISE, that the patient is a "good candidate," "candidate with a moderate resolution," and "poor candidate," is effective after PSG with MAD.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A - Pharyngeal Computed Tomography Group | – | Radiation: Pharyngeal Computed Tomography, Device: Mandibular Advancement Device22 randomly selected patients with mild to moderate obstructive sleep apnea will undergo pharyngeal CT with cephalometry and with registration in maximum comfortable protrusion (MCP) |
| Group B - Drug-Induced Sleep Endoscopy Group | – | Drug: Drug-Induced Sleep Endoscopy (Propofol), Device: Mandibular Advancement Device22 randomly selected patients with mild to moderate obstructive sleep apnea will undergo Drug-induced sleep endoscopy with registration in maximum comfortable protrusion (MCP) |
| Group C - Pharyngeal Computed Tomography and Drug-Induced Sleep Endoscopy Group | – | Radiation: Pharyngeal Computed Tomography, Drug: Drug-Induced Sleep Endoscopy (Propofol), Device: Mandibular Advancement Device22 randomly selected patients with mild to moderate obstructive sleep apnea will undergo a pharyngeal computed tomography + Drug-induced sleep endoscopy with registration in maximum comfortable protrusion (MCP) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study will present 66 adult patients diagnosed with mild or moderate OSAS (5 <AHI ≤ 30/h) through polysomnography (PSG) level III, referred from pulmonology, otorhinolaryngology and/or neurology for treatment with ADM, who refuse or do not tolerate the therapeutic approach of CPAP, in the sleep unit of Hospital CUF Tejo.
Key inclusion criteria (4 listed)
- Patients between 18 and 70 years of age with the indication for treatment with mandibular advancement device, who refused or cannot tolerate CPAP;
- Body Mass Index (BMI) between 19 and 34.9 Kg/m2;
- The presence of 8 healthy teeth or more per jaw (upper and lower );
- Maximum mandibular protrusion capacity of at least 6 mm.
Key exclusion criteria (7 listed)
- Significant nasal obstruction; chronic lung disease;
- Class III or IV congestive heart failure according to the New York Heart Association classification;
- Neuromuscular diseases or previous upper airway surgery unrelated to obstructive sleep apnea;
- Uncontrolled periodontitis;
- Tooth mobility;
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 |
|---|---|---|
| Pharyngeal Computed TomographyAlso: Pharyngeal CTTo assess the presence of a possible level/level of collapse, a pharyngeal CT with cephalometry will be performed, and a standard classification system, VOTE, will be used. After obtaining said CT, the dentist will place the recording in MCP and perform a new CT scan of the pharynx with cephalometry and with the MCP recording set intraorally to assess whether this position reduces or eliminates the collapse from UA. | Radiation | Group A - Pharyngeal Computed Tomography Group, Group C - Pharyngeal Computed Tomography and Drug-Induced Sleep Endoscopy Group |
| Drug-Induced Sleep Endoscopy (Propofol)Also: DISEThe DISE technique will be performed by an otorhinolaryngologist (ENT) with a nasopharyngoscope in a operating room. This technique is complemented with bite registration (MCP). Artificial sleep will be induced by intravenous administration of propofol through an infusion system controlled by an anesthesiologist (2.0-3.0 mcg/mL). The following variables will be continuously monitored: electrocardiography, oxygen saturation, and bispectral index (BIS). In this phase of the DISE, the upper airways will be evaluated during sleep with the MCP positioned intra-orally. | Drug | Group B - Drug-Induced Sleep Endoscopy Group, Group C - Pharyngeal Computed Tomography and Drug-Induced Sleep Endoscopy Group |
| Mandibular Advancement DeviceAlso: MADA duo-block, titratable, and customized MAD (NOA®; Orthoapnea) will be fitted for each patient who starts treatment with MAD. The MAD consists of two CAD/CAM polyamide intraoral devices (one for the upper and one for the lower arch). The adaptation period takes place over one month. After this adaptation, patients will undergo a new PSG using MAD. | Device | Group A - Pharyngeal Computed Tomography Group, Group B - Drug-Induced Sleep Endoscopy Group, Group C - Pharyngeal Computed Tomography and Drug-Induced Sleep Endoscopy Group |
Primary outcome
Changes in the apnea-hypopnea index
Time frame: Before making and starting to use the MAD and one and six months after
The apnea-hypopnea index will be registered with the level III polysomnography and we will evaluate after using the MAD if there were improvements or not, relating to the predictors that we analyzed before.
Changes in upper airway collapse analyzed by CT Pharyngeal
Time frame: Through study completion, an average of six months
the prognosis for the use of a MAD using the MCP recording and VOTE scoring system: when the upper airway collapse has entirely resolved (no residual collapse at any level of the upper airway), with the bite registration in MCP, the patient will be considered a "Good Candidate." Suppose there is only partial resolution (improvement, but with the residual or multilevel collapse of the upper airway) with the bite registration in PMC. In that case, you will qualify as a "moderately resolved candidate." If upper airway collapse remains unchanged or worsens with PMC bite registration, patients will be considered a "poor candidate."
Changes in Upper Airway collapse analyzed by DISE
Time frame: through study completion, an average of six months
Evaluation of the prognosis for the use of a MAD, we will use the mandibular advancement record in MCP. The VOTE classification: when the UA collapse is completely resolved (no residual collapse at any level of the upper airway), and there is no snoring, with the bite registration in MCP, the patient will be considered a "Good Candidate." Suppose there is only partial resolution (improvement, but with the residual or multilevel collapse of the UA) and some snoring with the bite registration in MCP. In that case, he will qualify as a "candidate with moderate resolution." If UA collapse remains unchanged or worsens with MCP bite registration and still snoring, patients will be considered a "bad candidate."
2 secondary outcomes
Subjective assessment of daytime sleepiness
Time frame: Before making and starting to use the MAD and one and six months after
Subjective assessment of quality of life
Time frame: Before making and starting to use the MAD and one and six months after
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
Related trials for Sleep Apnea, Obstructive
Not yet recruitingObservational study
Orthognathic Surgery and Obstructive Sleep Apnea Assessed by Mandibular Jaw Movement Monitoring (SUNRISE-ORTHO)
Obstructive Sleep Apnea, Sleep Apnea, Obstructive
Not yet recruitingObservational study
Association Between Metabolic Associated Fatty Liver Disease and Obstructive Sleep Apnea
Obstructive Sleep Apnea, Metabolic Dysfunction-Associated Steatotic Liver Disease
Not yet recruitingPhase 2/3
Tirzepatide Versus Positive Airway Pressure for the Treatment of Obstructive Sleep Apnoea
Sleep Apnoea, Obesity & Overweight
RecruitingObservational study
Development and Clinical Validation of Artificial Intelligence Algorithms for Sleep Staging and Obstructive Sleep Apnea Screening Based on a Large-Scale Model Trained on Multimodal Physiological Signals From Diverse Populations
Sleep Apnea, Obstructive, Sleep Staging
Not yet recruitingPhase 2
Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
Obesity & Overweight, Respiratory Depression
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.
Cristina Manso, PhD study director
Egas Moniz School of Health and Science
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 Sleep Apnea, Obstructive, run by Egas Moniz - Cooperativa de Ensino Superior, CRL at 1 site in Portugal.
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 4 inclusion and 7 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 3 Feb 2023. 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 Portugal. 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 Pedro Cebola, MSc (969153020 ext. +351, pc@pedrocebola.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the apnea-hypopnea index (time frame: Before making and starting to use the MAD and one and six months after). 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 3 Feb 2023.