SSNHL in Head & Neck Cancer Patients

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04609982
• Other study ID #: 24472
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 20, 2021
• Est. completion date: November 20, 2021

Study information

• Verified date: October 2020
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: November 20, 2021
• Est. primary completion date: August 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• ear plugs
giving half of the patients ear plugs

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Abdullah Aldaihani	Nova Scotia Health Authority

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hearing loss	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.	6 months