Predictive Factors for Prescribing a Mandibular Advancement Device for the Treatment of Obstructive Sleep Apnea
NCT ID: NCT05677620
Last Updated: 2023-02-03
Study Results
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Basic Information
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UNKNOWN
66 participants
OBSERVATIONAL
2023-03-31
2023-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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)
Pharyngeal Computed Tomography
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.
Mandibular Advancement Device
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.
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)
Drug-Induced Sleep Endoscopy (Propofol)
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 Device
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.
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)
Pharyngeal Computed Tomography
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)
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 Device
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.
Interventions
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Pharyngeal Computed Tomography
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)
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 Device
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
70 Years
ALL
Yes
Sponsors
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CUF Tejo Hospital
UNKNOWN
Orthoapnea
UNKNOWN
Egas Moniz - Cooperativa de Ensino Superior, CRL
OTHER
Responsible Party
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Principal Investigators
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Cristina Manso, PhD
Role: STUDY_DIRECTOR
Egas Moniz School of Health and Science
Locations
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CUF Tejo Hospital
Lisbon, , Portugal
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PHDPMC
Identifier Type: -
Identifier Source: org_study_id
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