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

NCT ID: NCT05596825

Last Updated: 2023-05-15

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-08
• Study Completion Date: 2024-04-29

Brief 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.

Conditions

Sleep Apnea

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Valencia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Sara Camañes Gonzalvo

Role: CONTACT

saracamanes@outlook.com

660150240 ext. +34

Other Identifiers

sacagon

Identifier Type: -

Identifier Source: org_study_id