SSNHL in Head & Neck Cancer Patients
Primary Purpose
Hearing Loss
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ear plugs
Sponsored by
About this trial
This is an interventional prevention trial for Hearing Loss
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
wearing ear plugs
Not wearing ear drops
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04609982
First Posted
October 15, 2020
Last Updated
October 26, 2020
Sponsor
Abdullah Aldaihani
Collaborators
Nova Scotia Health Authority
1. Study Identification
Unique Protocol Identification Number
NCT04609982
Brief Title
SSNHL in Head & Neck Cancer Patients
Official Title
Randomized Controlled Trial Evaluating the Impact of Noise Exposure in Otolaryngology Floor Among Head and Neck Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 20, 2021 (Anticipated)
Primary Completion Date
August 20, 2021 (Anticipated)
Study Completion Date
November 20, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Abdullah Aldaihani
Collaborators
Nova Scotia Health Authority
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
wearing ear plugs
Arm Type
Experimental
Arm Title
Not wearing ear drops
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
ear plugs
Intervention Description
giving half of the patients ear plugs
Primary Outcome Measure Information:
Title
Hearing loss
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
SSNHL in Head & Neck Cancer Patients
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