Active — Not RecruitingNot Applicable

The SATURİSTA Device

Turkey (Türkiye)7 participantsStarted 2026-03-15

Plain-language summary

This study aims to evaluate the functional performance and feasibility of the Saturista system, a novel device designed for automated oxygen flow regulation based on continuous monitoring of oxygen saturation (SpO₂). The system integrates real-time physiological monitoring, wireless data transmission, and centralized visualization to support timely detection of oxygen desaturation and clinical decision-making. A pilot feasibility study will be conducted in healthy volunteers using a scenario-based protocol, including baseline monitoring, controlled desaturation, probe disconnection, and signal recovery. The primary objective is to assess the system's ability to generate alarms in response to changes in SpO₂ and to display data in real time. Secondary objectives include evaluation of response time, signal management, and overall system stability.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Healthy adult volunteers aged 18 years or older * Resting oxygen saturation (SpO₂) within the normal range at baseline * Ability to understand the study procedures and provide written informed consent * Willingness to participate in all planned testing scenarios Exclusion Criteria: * History of chronic respiratory disease, including asthma, chronic obstructive pulmonary disease, or interstitial lung disease * Known cardiovascular disease or any condition that may affect oxygen saturation or hemodynamic stability * Current respiratory symptoms, acute infection, or fever at the time of participation * Anemia, peripheral circulatory disorders, or any condition that may interfere with pulse oximetry measurements * Skin lesions, deformity, or injury at the intended probe placement site * Pregnancy * History of syncope, intolerance to short-duration breath-holding, or any condition that may increase risk during testing * Inability or unwillingness to comply with study procedures

What they're measuring

Real-Time Data Display Performance

Timeframe: Day 1, during multiple predefined simulation scenarios applied sequentially within a single testing session

Trial details

NCT IDNCT07576946

SponsorKoç University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-06