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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
Abdullah Aldaihani
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hearing Loss

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts 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.

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

    First Posted
    October 15, 2020
    Last Updated
    October 26, 2020
    Sponsor
    Abdullah Aldaihani
    Collaborators
    Nova Scotia Health Authority
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    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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