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临床试验/NCT01533623
NCT01533623已完成不适用

The 1 Year Follow-up of Objective Measures of Oral Appliance Compliance for Treatment of Sleep-disordered Breathing (SDB): a Clinical Trial

University Hospital, Antwerp2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2012年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
51
试验地点
2
主要终点
Safety and feasibility of measuring objective mean wearing time

研究概览

简要总结

The investigators will perform a 1-year clinical trial measuring objective compliance during mandibular advancement device (MAD) treatment.

The investigators will enroll 50 patients that received treatment with a titratable, duobloc MAD (RespiDent Butterfly®, RespiDent, Nijlen, Belgium) and participated in the original study "Objective versus subjective compliance with oral appliance therapy for obstructive sleep apnea hypopnea syndrome", registered at Clinical Trials.gov (NCT01284881).

Active microsensors (TheraMon®,Handelsagentur Gschladt, Hargelsberg, Austria) are provided by the Handelsagentur Gschladt without any costs. The sampling interval of the recording will be done at a rate of 1 measurement per 15 minutes (every 900 seconds). Using this sample interval, the capacity of the active microsensor allows for data acquisition during a 100 day period.

A follow-up appointment is scheduled +/- 265 days after the start of the original study. A second follow-up visit is scheduled again 1 year after the start of the original study.

The objective measurement of MAD wear time (total hours of wear time and the mean hours of wear per night over the respective period) will be based on the assumption that the MAD has been worn when the chip records a temperature intraorally.

详细描述

This clinical trial is an extension to trial 10/48/340, registered at Clinical Trials.gov (NCT01284881).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
Single (Participant)

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

  • clinical diagnosis of sleep-disordered breathing
  • started treatment with a titratable, duobloc mandibular advancement device
  • participated in original study 10/48/340 (3 month follow-up of compliance during treatment with mandibular advancement device)

排除标准

  • dental exclusion criteria for mandibular advancement devices
  • medical contra-indications for mandibular advancement devices

结局指标

主要结局

Safety and feasibility of measuring objective mean wearing time

时间窗: 1 year

To assess the safety and feasibility of measuring objective mean wearing time as a measure of objective oral appliance wear. The objective mean wearing time will be assessed using a microsensor thermometer. Regular follow-up visits will be performed, and patients will be questioned regarding side-effects of the microsensor.

次要结局

  • therapeutic index(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ethisch Comité UZ Antwerpen

principal Investigator

University Hospital, Antwerp

研究点 (2)

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