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

Completed

• Conditions: Obstructive Sleep Apnea

• Registration Number: NCT04427111
• Lead Sponsor: Bahadır EZMEK

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-24
• Primary Completion: 2017-12-24
• Study Completion: 2017-12-24
• Status Verified: 2020-06
• Study First Submitted: 2020-06-04
• Study First Submitted QC: 2020-06-08
• Last Update Submitted: 2020-06-08
• Study First Posted: 2020-06-11
• Last Update Posted: 2020-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from Baseline Apnea-Hypopnea Index (AHI) at 6 months	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 Outcome Measures

Name	Time	Method
Snoring index (SI)	at baseline and in 6 months	SI was used to evaluate snoring events per hour during PSG
Simple pulse oximeter (SPO)/ODI	at baseline and 1, 4, 12, and 24 week of MAD treatment	SPO/ODI was used to evaluate the desaturation fluctuations during sleep in-home environment by using simple pulse oximeter device
Smartphone sleep application (SSA)/snoring intensity score (SIS)	at baseline and 1, 4, 12, and 24 week of MAD treatment	SSA/SIS was used to evaluate snoring intensity that was calculated by SSA during sleep in-home environment. No information exists about how to calibrate the SSA to calculate SIS
SSA/snoring percentage (SP)	at baseline and 1, 4, 12, and 24 week of MAD treatment	SSA/SP was the ratio of total snoring time to total sleep time that was calculated by SSA during sleep in-home environment. No information exists about how to calibrate the SSA to calculate SP.
Oxygen-desaturation index (ODI)	at baseline and in 6 months	ODI was used to evaluate the desaturation fluctuations during full night PSG. ODI is defined as 3-4% decrease in oxygen saturation per hour.