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

Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05596825
• Other study ID #: sacagon
• Status: Not yet recruiting
• Start date: July 8, 2023
• Est. completion date: April 29, 2024

Study information

• Verified date: October 2022
• Source: University of Valencia
• Contact: Sara Camañes Gonzalvo
• Phone: 660150240
• Email: saracamanes[@]outlook.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: April 29, 2024
• Est. primary completion date: December 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Mandibular Advancement Device
To analyze the phenotypic characteristics of different subgroups of patients with obstructive sleep apnea syndrome who respond better (complete responders) or worse (partial responders or non-responders) to treatment with mandibular advancement devices. Responders will be defined as a post-treatment AHI of less than 10/h and at least a 50 percent reduction in their AHI. Partial responders will be defined as a post-treatment AHI greater than 10/hour but at least a 50 percent reduction in AHI, and non-responders as less than a 50 percent reduction compared to baseline.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gender	Male or Female	1 day
Primary	Age	Age described as "years and months". The age of the patients at the beginning of the study	1 day
Primary	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
Primary	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
Primary	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
Primary	apnea - hypopnea index	number of apnea and hypopnea per hours of sleep before and after the device's placement.	6 months
Primary	minimum oxygen saturation	It is the minimum oxyhemoglobin saturation during a sleep study. Expressed in %.	6 months