Assessing Factors in Tinnitus Patients' Clinical Study Experiences

Sponsor
Power Life Sciences Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05811871
Collaborator
(none)
500
24

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Case-Crossover
    Time Perspective:
    Prospective
    Official Title:
    Examining Variables Affecting Patient Participation in Clinical Trials for Tinnitus
    Anticipated Study Start Date :
    Apr 1, 2024
    Anticipated Primary Completion Date :
    Apr 1, 2025
    Anticipated Study Completion Date :
    Apr 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Number of tinnitus patients who decide to enroll in a clinical study [3 months]

    2. Rate of tinnitus patients who remain in a clinical study to completion [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Power Life Sciences Inc.

    Investigators

    • Study Director: Michael B Gill, Power Life Sciences Inc.

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Power Life Sciences Inc.
    ClinicalTrials.gov Identifier:
    NCT05811871
    Other Study ID Numbers:
    • 84411336
    First Posted:
    Apr 13, 2023
    Last Update Posted:
    Apr 13, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Power Life Sciences Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 13, 2023