Marmara University and Başakşehir Çam & Sakura City Hospital have joined forces to adapt a pediatric sleep screening tool designed to address complex chronic conditions for Turkish-speaking patients. The study, as listed on ClinicalTrials.gov, signals a step toward ensuring comprehensive care for children with chronic illnesses in Turkey. Though not yet recruiting, the announcement hints at forthcoming clinical collaboration, benefitting healthcare regulatory, quality, and clinical teams alongside manufacturers interested in pediatric diagnostic tools.
In this article:
- What changed?
- Research objectives
- Study status and implications
- FAQ
- Conclusion
- Disclaimer
- Link to announcement
What changed?
The adaptation of a sleep screening tool specifically for Turkish pediatric patients introduces a localized solution for identifying sleep disorders among children with complex chronic conditions. This initiative caters to the unique linguistics and healthcare needs of the region. The sponsors aim to align the tool with regulatory medical device standards, ensuring it is optimized for precise, clinically validated use in Turkey’s healthcare system.
Research objectives
The study’s primary goal is to develop and deploy a linguistically and culturally adapted version of the existing sleep screening tool. This process involves translating and validating the tool to meet the needs of both clinicians and patients in bilingual or monolingual Turkish environments. Marmara University’s leadership emphasizes evidence-based methodologies to ensure the tool performs reliably and supports the identification of sleep disorders across varying severity levels.
Focus on pediatric populations
Complex chronic conditions significantly impact pediatric patients, disrupting their sleep and overall quality of life. By offering a validated screening mechanism, providers can better identify and manage sleep disorders efficiently, supporting improved long-term outcomes.
Integration potential with broader pediatric strategies
The tool could integrate into broader pediatric care plans, including intensive care protocols. Hospitals focusing on chronic pediatric diseases may leverage this tool to enhance diagnostic capabilities and refine therapeutic recommendations.
Study status and implications
As of now, the trial is listed as ‘Not yet recruiting’ on ClinicalTrials.gov, indicating that the recruitment phase has not begun. This status suggests preliminary planning phases are still underway, and parties interested in involvement may track updates to identify future participation opportunities.
For device manufacturers and regulatory professionals, developments in pediatric diagnostic tools like this one offer insights into region-specific device design processes. The outcome could serve as a blueprint for adapting devices and tools in other linguistically diverse markets.
FAQ
1. What does ‘not yet recruiting’ mean?
This means the study team is still preparing for recruitment but has not yet started enrolling participants.
2. Who is funding this study?
The study is sponsored jointly by Marmara University and Başakşehir Çam & Sakura City Hospital.
3. How will this tool help physicians?
The adapted tool will simplify the screening process for sleep disorders in children with chronic conditions, allowing for faster and more accurate identification of clinical problems.
Conclusion
The planned study on the Turkish adaptation of the pediatric sleep screening tool shows promise for advancing diagnostics in chronic pediatric conditions. Healthcare and device professionals should monitor this study for updates to assess sector implications and opportunities.
Disclaimer
This post is informational in nature and does not constitute legal or regulatory advice. For specific guidance, consult professional counsel or official documentation.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07210476?term=medical+device