Predictive Factors for Prescribing a Mandibular Advancement Device for the Treatment of Obstructive Sleep Apnea

Sleep Apnea, Obstructive Clinical Trial

Official title:

Predictive Morphological Factors for Prescribing a Mandibular Advancement Device in the Therapeutic Approach of Obstructive Sleep Apnea

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05677620
• Other study ID #: PHDPMC
• Status: Not yet recruiting
• Start date: March 2023
• Est. completion date: December 2023

Study information

• Verified date: February 2023
• Source: Egas Moniz - Cooperativa de Ensino Superior, CRL
• Contact: Pedro Cebola, MSc
• Phone: 969153020
• Email: pc[@]pedrocebola.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

Description:

This study will present 66 adult patients diagnosed with mild or moderate OSA (5

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: December 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Radiation:
• 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:
• 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.

Device:
• 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.

Locations

Country	Name	City	State
Portugal	CUF Tejo Hospital	Lisbon

Sponsors (3)

Lead Sponsor	Collaborator
Egas Moniz - Cooperativa de Ensino Superior, CRL	CUF Tejo Hospital, Orthoapnea

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Before making and starting to use the MAD and one and six months after
Primary	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."	Through study completion, an average of six months
Primary	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."	through study completion, an average of six months
Secondary	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	Before making and starting to use the MAD and one and six months after
Secondary	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.	Before making and starting to use the MAD and one and six months after