February 2, 2024 at 9:48 pm
Relationship Between Sleep Quality and Day-to-Day Impact of Tinnitus: A Pilot Study
There is currently no study to assess the relationship between night-to-night variations in sleep and the subsequent impact of tinnitus, using multiple repeated measures – until now. This research study will explore how different types and qualities of sleep change the impact of tinnitus, and vice versa. It will aim to answer questions like, “When my quality of sleep changes throughout the night, does this affect my tinnitus the next day?” and “What happens to my tinnitus while I experience different stages of sleep?” The closer we get to answering these questions, the better treatment and advice we can offer to patients.
What will this research study cost?
The cost for conducting this research study is £30,000. This will cover:
How do I donate to support this research study?
You can donate by following this link, we thank you in advance for your generosity:
www.hashirtinnitusclinic.com/donate
How do I find out more?
Below you will find the details about how we will conduct this study, and who will be sponsoring it. If you have further questions, please email us via admin@hashirtinnitusclinic.com .
Study Design
Pilot Study, mixed methods with embedded design
Study Participants
Two groups of individuals: those with tinnitus and those without (Control)
Planned Sample Size
10 patients in each group
Follow-up Duration
14 days
Planned Study Period
6 months
Principal Investigator
Dr. Hashir Aazh
Co-Investigator
Dr. Mercede Erfanian
Sponsor
Hashir International Specialist Clinics & Research Institute for Misophonia, Tinnitus, and Hyperacusis Ltd.
Role of the Sponsor
As the sponsor institution, we bear the responsibility of ensuring that the research undergoes independent scientific peer review, confirming its worthiness and value for money. We will ensure the availability of necessary resources to conduct high-quality, cost-effective research. Additionally, we will approve suitable investigators and document the allocation of responsibilities. Prior to commencing the research, we will ensure that all required approvals, permissions, and licenses are obtained.
Furthermore, we will establish systems for addressing complaints and handling misconduct, as well as for reporting, recording, and reviewing adverse events. Agreements will be made to identify, protect, and exploit intellectual property related to the research. We are obligated to ensure that the research is conducted in accordance with all relevant laws and best practices, including regulations such as the General Data Protection Regulation (GDPR) and the Mental Capacity Act (2005).
We will ensure that the research adheres to the approved protocol and the terms and conditions of relevant approvals. Given the importance of monitoring the research, we will maintain key records and documents in a legible condition. Any modifications to the study design will require approval from us as the sponsor, and arrangements will be made to secure any additional necessary approvals.
Upon completion of the research, we will notify relevant approval bodies, and collected data will be retained for the appropriate duration. Lastly, we will have appropriate plans in place for the dissemination of study findings.
