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

NCT05677620 | Unknown DMC FDA Device

• 1 other identifier: PHDPMC
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep Apnea, Obstructive

Keywords

Oral Appliance; DISE; Computed Tomography; Mandibular Advancement Device

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Subjective assessment of daytime sleepiness

  Before making and starting to use the MAD and one and six months after

• Subjective assessment of quality of life

  Before making and starting to use the MAD and one and six months after

Study Arms (3)

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)

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)

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)

Radiation: Pharyngeal Computed Tomography; Drug: Drug-Induced Sleep Endoscopy (Propofol); Device: Mandibular Advancement Device

Interventions

Pharyngeal Computed Tomography RADIATION

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.

Also known as: Pharyngeal CT

Group A - Pharyngeal Computed Tomography Group; Group C - Pharyngeal Computed Tomography and Drug-Induced Sleep Endoscopy Group

Drug-Induced Sleep Endoscopy (Propofol) DRUG

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.

Also known as: DISE

Group B - Drug-Induced Sleep Endoscopy Group; Group C - Pharyngeal Computed Tomography and Drug-Induced Sleep Endoscopy Group

Mandibular Advancement Device 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.

Also known as: MAD

Group A - Pharyngeal Computed Tomography Group; Group B - Drug-Induced Sleep Endoscopy Group; Group C - Pharyngeal Computed Tomography and Drug-Induced Sleep Endoscopy Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Egas Moniz - Cooperativa de Ensino Superior, CRL: lead
• CUF Tejo Hospital: collaborator
• Orthoapnea: collaborator

Study Sites (1)

CUF Tejo Hospital

Lisbon, 1350-352, Portugal

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Propofol; Occlusal Splints

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Cristina Manso, PhD

  Egas Moniz School of Health and Science

  STUDY DIRECTOR

Central Study Contacts

Pedro Cebola, MSc

CONTACT

969153020; pc@pedrocebola.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: January 10, 2023
• Study Start: March 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)