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SSNHL in Head & Neck Cancer Patients

N

Nova Scotia Health Authority (NSHA)

Status

Withdrawn

Conditions

Hearing Loss

Treatments

Device: ear plugs

Study type

Interventional

Funder types

Other

Identifiers

NCT04609982
1025581

Details and patient eligibility

About

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.

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

0 participants in 2 patient groups

wearing ear plugs
Experimental group
Treatment:
Device: ear plugs
Not wearing ear drops
No Intervention group

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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