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临床试验/NCT04609982
NCT04609982撤回不适用

Randomized Controlled Trial Evaluating the Impact of Noise Exposure in Otolaryngology Floor Among Head and Neck Cancer Patients

Nova Scotia Health Authority0 个研究点开始时间: 2021年2月20日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Hearing loss

研究概览

简要总结

A sound dosimeter will be used to measure noise level to which a population of head and neck patients on the otolaryngology ward are exposed to. The device is the EXTECH 407764 type II sound level meter (IEC 651 RS232). The device will be configured to OSHA and ISO standards, and calibration confirmed in a sound booth with a sound level calibrator. The dosimeter captures A-weighted sound levels between 30 and 130 dB. Specifically, participants included in the study will be head and neck cancer patients on the otolaryngology floor at VG site. Measurements will be taken three times a day at random intervals. Each measurement will be taken in a similar manner. The dosimeter will be placed on the head side of the bed at the level of patient's ear one inch away from the ear and kept there for ten seconds to get a representative level. The overall measurements will be averaged (Leq) for statistical analysis. Investigators will randomly select 50% of the patients and give them protective ear plugs to be used while the participants are inpatients, and the other 50% will not provide them with ear plugs (like what is being done now). Investigators will obtain a baseline hearing test prior to admission and 7 days after admission and then a repeat hearing test at 3 weeks after discharge. The goal is to establish if there is a temporary or a permanent threshold shift.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

入排标准

性别
All
接受健康志愿者

入选标准

  • Clinical diagnoses of head and neck disease requiring surgery.
  • Must be expected to be admitted to ENT floor.
  • Must be able to conduct a hearing test.

排除标准

  • a diagnoses of SNHL.
  • participants with low mental capacity.

结局指标

主要结局

Hearing loss

时间窗: 6 months

investigators will measure the level hearing loss during the patients stay using a hearing test done by an audiologist. the rate level of hearing loss will be measured by dB using an audiogram.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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