Therapeutic Efficiency of Mandibular Advancement Device Using Smartphone Sleep Applications and Pulse Oximeter

Bahadır EZMEK

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: Non-titratable-customized mandibular advancement device

Study type: Observational

Funder types: Other

Identifiers

NCT04427111

2015-KAEK-84

Details and patient eligibility

About

An observational clinical trial in a single centre. The objective of this study was to determine the efficacy of mandibular advancement device (MAD) therapy on snoring intensity, frequency, and oxygen desaturation periods in mild-moderate obstructive sleep apnea (OSA) patients with snoring problems. Totally, 18 mild-moderate OSA patients (8 females and 10 males) with subjective snoring complaint were selected. Each patient's diagnostic polysomnographic analysis (PSG) was accepted as initial PSG values. Each patient was subjected simple pulse oximeter (SPO) and smartphone sleep application (SSA) at 3 different nights at home. Diagnostic mean values of oxygen desaturation index (obtained by using SPO), snoring intensity score (obtained by using SSA), and snoring percentage (obtained by using SSA) were recorded. Non-titratable-customized MAD with 60-75% of maximal mandibular protrusion were fabricated. The patients were instructed to wear their MAD every night. SPO and SSA measurement were repeated at the 1st, 4th, 12th, and 24th week of the treatment process. At the 24th week of treatment, The PSG were repeated and all PSG, SPO, and SSA values were compared with initial diagnostic values.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• mild-moderate OSA patients with subjective snoring complaints

Exclusion criteria

• Severe OSA
• Undergone previous surgical therapy for SS or OSA
• High-risk of cardiovascular, respiratory, neurological, or psychiatric disorders
• Inadequate dental anchor for MAD treatment
• Temporomandibular joint dysfunction
• Angle Class III maxillomandibular relation

Trial design

18 participants in 1 patient group

Mild-moderate OSA patients for MAD treatment

Description:

Patients are classified as mild Obstructive Sleep Apnea (OSA) if they have between 5-15 Apnea-Hypopnea Index, moderate if they have between 15-30, and severe if they have \>30, as measured by Polysomnography (Epstein LJ, Kristo D, Strollo PJ, et al. 2009). The principal treatment methodology for OSA patients is positive airway pressure. In patients with mild to moderate OSA, oral appliances such as mandibular advancement devices (MAD) is alternately indicated (Ramar K, Dort LC, Katz SG, et al. 2015) The American Academy of Dental Sleep Medicine (Ramar K, Dort LC, Katz SG, et al. 2015) recommended titratable-customized MADs for patient comfort and the ability to permit modifications in the amount of mandibular protrusion for treatment efficacy. However, Aarab et al (Aarab G, Lobbezoo F, Hamburger HL, Naeije M. 2010) demonstrated similar therapeutic efficiency of non-titratable-customized MADs in the treatment of OSA

Treatment:

Device: Non-titratable-customized mandibular advancement device