TinnitusNCT05811871
Assessing Factors in Tinnitus Patients' Clinical Study Experiences
An observational study of Tinnitus, run by Power Life Sciences Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tinnitus
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Tinnitus patients who are actively considering participating in an observational medical study, but have not yet completed enrollment and randomization.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Tinnitus
- Keywords
- tinnitus
- Medical subject headings
- Tinnitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of tinnitus patients who decide to enroll in a clinical study
Measured: 3 months
Rate of tinnitus patients who remain in a clinical study to completion
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study startApr 2024 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by Power Life Sciences Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Power Life Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael B Gill, Study director, Power Life Sciences Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05811871
- Sponsor's protocol ID
- 84411336
- Status last verified
- Mar 2023
- First submitted
- 31 Mar 2023
- Last updated
- 13 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33374519Farr 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.
PubMed 26314274Tinnitus 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.
PubMed 31120533
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Variables Affecting Patient Participation in Clinical Trials for Tinnitus
- ClinicalTrials.gov ID
- NCT05811871
- Acronym / sponsor ID
- 84411336
- Conditions
- Tinnitus
- Keywords
- tinnitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Power Life Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2024 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 13 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Tinnitus patients who are actively considering participating in an observational medical study, but have not yet completed enrollment and randomization.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of tinnitus patients who decide to enroll in a clinical study
Time frame: 3 months
Rate of tinnitus patients who remain in a clinical study to completion
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Background: PubMed 33374519Natalini 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.
- Background: PubMed 26314274Farr 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.
- Background: PubMed 31120533Tinnitus 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael B Gill study director
Power Life Sciences Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Tinnitus, run by Power Life Sciences Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael B Gill (4159004227, bask@withpower.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of tinnitus patients who decide to enroll in a clinical study (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05811871, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.