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AI-Powered oxygen regulator tested in healthy volunteers

NCT ID NCT07576946

Knowledge-focused Sponsor: Koç University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new device called Saturista that uses artificial intelligence to automatically adjust oxygen flow based on a person's oxygen levels. Seven healthy volunteers will go through different scenarios, like a drop in oxygen or a disconnected sensor, to see if the device correctly triggers alarms and displays data in real time. The goal is to check if the system works reliably before testing it in patients who need oxygen therapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Saturista device (artificial intelligence-assisted automated oxygen flow regulation system)
What this could lead to
If successful, this device could help automate oxygen therapy in hospitals, potentially improving patient safety and freeing up healthcare workers.
What could go wrong
This is a very early feasibility study with only 7 healthy volunteers, not patients. It tests basic functions like alarms and data display, not real-world treatment outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 7 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population consists of healthy adult volunteers recruited for a pilot feasibility evaluation of the Saturista system. Participants are individuals without known respiratory or cardiovascular disease and with normal baseline oxygen saturation levels. The purpose of selecting a healthy population is to assess the technical performance and functional reliability of the system under controlled conditions before clinical testing in patient populations. All participants will undergo a structured, scenario-based testing protocol, including baseline monitoring, controlled desaturation maneuvers within safe physiological limits, probe disconnection, and signal recovery. This population allows for standardized assessment of the system's ability to monitor SpO₂, generate alarms, display real-time data, and manage signal-related events without the confounding effects of underlying clinical conditions.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Oxygen therapy

Contacts and locations

Locations

  • Istinye University

    Istanbul, Turkey (Türkiye)