Therapeutic Efficiency Analyses of Mandibular Advancement Devices on Obstructive Sleep Apnea Using Polysomnography, Smartphone Sleep Applications, and Simple Pulse Oximeter
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obstructive Sleep Apnea
- Sponsor
- Bahadır EZMEK
- Enrollment
- 18
- Primary Endpoint
- Change from Baseline Apnea-Hypopnea Index (AHI) at 6 months
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Investigators
Bahadır EZMEK
Assistant Professor
Saglik Bilimleri Universitesi Gulhane Tip Fakultesi
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change from Baseline Apnea-Hypopnea Index (AHI) at 6 months
Time Frame: at baseline and in 6 months
AHI was defined as total number of apnea or hypopnea events which lasts for at least ten seconds per hour during full nigth polysomnography (PSG) and accepted to be the main physiological sleep parameter in the present study. The AHI values were used for the evaluation of the severity of OSA and the MAD's treatment success in OSA patients
Secondary Outcomes
- Oxygen-desaturation index (ODI)(at baseline and in 6 months)
- Snoring index (SI)(at baseline and in 6 months)
- Simple pulse oximeter (SPO)/ODI(at baseline and 1, 4, 12, and 24 week of MAD treatment)
- Smartphone sleep application (SSA)/snoring intensity score (SIS)(at baseline and 1, 4, 12, and 24 week of MAD treatment)
- SSA/snoring percentage (SP)(at baseline and 1, 4, 12, and 24 week of MAD treatment)