Assessing Factors in Tinnitus Patients' Clinical Study Ex... | NCT05811871

Studies
Assessing Factors in Tinnitus Patients' Clinical Study Experiences

NCT05811871

Sponsor

Power Life Sciences Inc.

Status

Unknown status

Last Update Posted

Apr 13, 2023Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Tinnitus

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2024Estimated

Primary Completion Date

Apr 2025Estimated

Completion Date

Apr 2026Estimated

First Submitted Date

Mar 31, 2023

First Submission Date that Met QC Criteria

Mar 31, 2023

First Posted Date

Apr 13, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2023

Last Update Posted Date

Apr 13, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Michael B Gill	Contact	4159004227		bask@withpower.com

Overall Officials

Name	Affiliation	Role
Michael B Gill	Power Life Sciences Inc.	Study Director

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33374519	Background	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.
26314274	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.

ID	Term
D006311	Hearing Disorders
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases
D012678	Sensation Disorders