Phenotypic Characteristics of Responders to Obstructive Sleep Apnea Treatment Using Mandibular Advancement Devices

Currently, mandibular advancement devices (MAD) are recommended by the American Academy of Sleep Medicine (AASM) as the first treatment a line in cases of mild and moderate OSAS in patients without severe cardiovascular comorbidity and in severe OSAS when treatment with CPAP fails or is rejected. Although oral appliances (OD) have less impact on AHI reduction, both treatments have been shown to have a similar impact on clinical outcomes, including symptomatology and cardiovascular outcomes. In addition, MAD is a treatment that is better tolerated by patients, which results in greater compliance on their part, and therefore a similar efficacy in clinical practice.

Its mechanism of action consists of maintaining the patency of the upper airway, preventing collapse. They act by correcting the anatomical imbalance of patients with OSAS, specifically stabilizing and increasing the space of the velopharyngeal airways, reducing their collapsibility.

However, the effectiveness of the treatment of this pathology using MAD is limited by the inter-individual preference of the results of the treatment and the lack of information in the correct selection of the appropriate patients. In fact, oral appliances are an effective treatment for 60-70% of patients. Therefore, the precise selection of patients is essential to optimize the results of MAD treatment and thus avoid the necessary costs. This justifies the need to identify phenotypes likely to predict response to MAD treatment.

Study Overview

• Status: Not yet recruiting
• Conditions: Sleep Apnea
• Intervention / Treatment: Device: Mandibular Advancement Device

• Study Type: Observational
• Enrollment (Anticipated): 75

Contacts and Locations

• Study Contact: Name: Sara Camañes Gonzalvo; Phone Number: +34 660150240; Email: saracamanes@outlook.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients from the Master's Degree in Prosthodontics and Occlusion at the University of Valencia will be selected. At the dental clinic of the Lluis Alcanyis Foundation. Located in Gascó Oliag Nº 1, Valencia.

Description

Inclusion Criteria:

• Patients older than 18 years
• Adult patients with obstructive sleep apnea diagnosed according to the third edition of the International Classification of Sleep Disorders.
• Apnea-hypopnea index (AHI) of at least 5/hour of sleep.

Exclusion Criteria:

• Patients with heart disease.
• Central sleep apnea.
• Patients who had degenerative pathologies of the temporomandibular joint.
• Patients who had moderate or advanced periodontal disease.
• Pregnant patients.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gender	Male or Female	1 day
Age	Age described as "years and months". The age of the patients at the beginning of the study	1 day
Body mass index	Weight and height will be combined to report BMI in kg/m^2. The body mass index at the beginning of the study.	1 day
Epworth Daytime Sleepiness Scale	The ESS is a self-administered questionnaire that evaluates sub- jective daytime sleepiness in quotidian situations. The score ranges from 0 to 24 and is usually elevated in sleep apnea patients, indicating a propensity to fall asleep. An ESS score above 10 is considered abnormal and a maximum score of 24 indicates severe somnolence.	1 day
Anatomical characteristics	Craniofacial and airway features from cone beam computed tomography. (eg. maxillary length (mm), mandibular length (mm), anterior facial height (mm), posterior facial height (mm), distance between hyoid bone and mandibular plane (mm), distance between retrognation point and mandibular plane (mm), upper airway length (mm), superior airway space (mm) and inferior airway space (mm)).	12 months
apnea - hypopnea index	number of apnea and hypopnea per hours of sleep before and after the device's placement.	6 months
minimum oxygen saturation	It is the minimum oxyhemoglobin saturation during a sleep study. Expressed in %.	6 months

Collaborators and Investigators

• Sponsor: University of Valencia

Study record dates

Study Major Dates

• Study Start (Anticipated): July 8, 2023
• Primary Completion (Anticipated): December 8, 2023
• Study Completion (Anticipated): April 29, 2024

Study Registration Dates

• First Submitted: October 10, 2022
• First Submitted That Met QC Criteria: October 24, 2022
• First Posted (Actual): October 27, 2022

Study Record Updates

• Last Update Posted (Actual): May 15, 2023
• Last Update Submitted That Met QC Criteria: May 12, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: sleep apnea syndrome; mandibular advancement device
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: sacagon

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO