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临床试验/NCT04427111
NCT04427111已完成不适用

Therapeutic Efficiency Analyses of Mandibular Advancement Devices on Obstructive Sleep Apnea Using Polysomnography, Smartphone Sleep Applications, and Simple Pulse Oximeter

Bahadır EZMEK0 个研究点目标入组 18 人开始时间: 2015年12月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
18
主要终点
Change from Baseline Apnea-Hypopnea Index (AHI) at 6 months

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • mild-moderate OSA patients with subjective snoring complaints

排除标准

  • 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

结局指标

主要结局

Change from Baseline Apnea-Hypopnea Index (AHI) at 6 months

时间窗: 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

次要结局

  • 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)

研究者

发起方
Bahadır EZMEK
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Bahadır EZMEK

Assistant Professor

Saglik Bilimleri Universitesi Gulhane Tip Fakultesi

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