Assessing Factors in Tinnitus Patients' Clinical Study Experiences

NCT05811871 | Not Yet Recruiting

• 1 other identifier: 84411336
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tinnitus

Keywords

tinnitus

Outcome Measures

Primary Outcomes (2)

• Number of tinnitus patients who decide to enroll in a clinical study

  3 months

• Rate of tinnitus patients who remain in a clinical study to completion

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Power Life Sciences Inc.: lead

Related Publications (3)

• Natalini E, Fioretti A, Riedl D, Moschen R, Eibenstein A. Tinnitus and Metacognitive Beliefs-Results of a Cross-Sectional Observational Study. Brain Sci. 2020 Dec 23;11(1):3. doi: 10.3390/brainsci11010003.

  PMID: 33374519 BACKGROUND

• Farr MR, Moraleda Deleito J, Xu Y, Ray J. Developing a one-stop tinnitus service: outcomes of a joined up management strategy: a retrospective observational cohort study. J Eval Clin Pract. 2016 Feb;22(1):93-97. doi: 10.1111/jep.12442. Epub 2015 Aug 28.

  PMID: 26314274 BACKGROUND

• Tinnitus Retraining Therapy Trial Research Group; Scherer RW, Formby C. Effect of Tinnitus Retraining Therapy vs Standard of Care on Tinnitus-Related Quality of Life: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2019 Jul 1;145(7):597-608. doi: 10.1001/jamaoto.2019.0821.

  PMID: 31120533 BACKGROUND

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael B Gill

  Power Life Sciences Inc.

  STUDY DIRECTOR

Central Study Contacts

Michael B Gill

CONTACT

4159004227; bask@withpower.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: April 13, 2023
• Study Start: April 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2026
• Last Updated: April 13, 2023

Record last verified: 2023-03