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Local Heat-Stress as a Mechanism of Hearing Preservation

NCT02872844 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-08-22

No results posted yet for this study

Summary

This pilot study plans to determine whether or not local heat-stress as a mechanism can help to preserve hearing in adults treated with Cisplatin.

Conditions

Interventions

DEVICE

ICS AirCal3

Each patient will undergo a 30-minute heat stress to one ear. For randomization, the left ear will be treated in patients with a registration number ending with an odd number and the right for even numbers. An ICS AirCal3 Research Strategy (Otometrics) system attached to an Intel Core 15vPro Thinkpad (IBM) laptop is used within the audiometry department of a separate outpatient clinic. The patients will be reclined and the hot air caloric at 50°C applied by a licensed, unblinded audiologist for 30 minutes. The patients will be allowed to fixate and use whatever means they prefer for entertainment during the intervention.

Sponsors & Collaborators

  • University of Nebraska

    lead OTHER

Principal Investigators

  • Paul Judge, MD · University of Nebraska

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-03
Primary Completion
2018-12-13
Completion
2018-12-13

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02872844 on ClinicalTrials.gov