Assessing Factors in Tinnitus Patients' Clinical Study Experiences

March 31, 2023 updated by: Power Life Sciences Inc.

Examining Variables Affecting Patient Participation in Clinical Trials for Tinnitus

Clinical trials can sometimes favor certain demographic groups. Additionally, there is limited research that delves into the factors that influence participation in clinical trials, both positive and negative.

The goal is to identify the obstacles and challenges that prevent participation in tinnitus clinical studies, as well as the reasons for withdrawal or discontinuation.

The insights gained from this study will ultimately benefit those with tinnitus who may be invited to participate in clinical research in the years to come.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Tinnitus patients who are actively considering participating in an observational medical study, but have not yet completed enrollment and randomization.

Description

Inclusion Criteria:

  • Diagnosed with tinnitus
  • Willing to comply with all study related procedures and assessments
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • No documented diagnosis of tinnitus
  • Any other health problems that would prohibit safe participation in the study
  • Pregnant or planning to become pregnant while enrolled in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of tinnitus patients who decide to enroll in a clinical study
Time Frame: 3 months
3 months
Rate of tinnitus patients who remain in a clinical study to completion
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Power Life Sciences Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2024

Primary Completion (Anticipated)

April 1, 2025

Study Completion (Anticipated)

April 1, 2026

Study Registration Dates

First Submitted

March 31, 2023

First Submitted That Met QC Criteria

March 31, 2023

First Posted (Actual)

April 13, 2023

Study Record Updates

Last Update Posted (Actual)

April 13, 2023

Last Update Submitted That Met QC Criteria

March 31, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 84411336

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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