Chronic Respiratory FailureNCT06952816
Automated Oxygen Titration With the EMILY.AI Device in a Respiratory Intermediate Care Unit
A study testing Emily.AI and Manual oxygen titration in people with Chronic Respiratory Failure and Acute Respiratory Failure, run by Aether Tech S.L. at 1 site in Spain.
Trial summary
This study evaluates EMILY.AI, an investigational (non-CE-marked) smart oxygen valve that automatically adjusts the oxygen flow delivered to a patient, second by second, according to oxygen saturation (SpO2), heart rate and respiratory rate measured by a pulse oximeter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Respiratory Failure, Acute Respiratory Failure, Hypoxemic Respiratory Failure
- What is being tested?
- Emily.AI and Manual oxygen titration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 15 Apr 2025to 30 Mar 2027
- Phase
- Interventional
- 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
Who may be able to join
- Men and women over 18 years of age or older.
- Admitted to the Respiratory Intermediate Care Unit with acute respiratory failure, defined as baseline arterial PaO2 below 60 mmHg or the need for supplemental oxygen to maintain SpO2 above 90%. Patients on long-term oxygen therapy are eligible if a clinical deterioration requires a higher-than-usual oxygen flow to maintain SpO2 above 90%.
- Spontaneous breathing without positive-pressure ventilatory support (invasive or non-invasive mechanical ventilation, or CPAP) for at least 8 consecutive hours.
- Able to understand the study and sign informed consent.
Who cannot join
- Hemodynamic instability or need for vasoactive drugs.
- Severe temperature changes (axillary temperature above 39 °C or below 35 °C).
- Hemoglobinopathies or severe anemia (hemoglobin below 7 g/dL).
- Severe acidosis (pH below 7.20) or severe alkalosis (pH above 7.55).
- Anatomical abnormalities preventing correct placement of the pulse oximeter.
- Pregnancy or breastfeeding (women of childbearing potential require a negative pregnancy test at screening).
- Oxygen flow requirement exceeding the valve capacity (more than 40 L/min).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional, Clinical, and Predictive Validation Study of the EMILY AI Device in Patients With Acute and Chronic Respiratory Failure: Respiratory Intermediate Care Unit Substudy
This study evaluates EMILY.AI, an investigational (non-CE-marked) smart oxygen valve that automatically adjusts the oxygen flow delivered to a patient, second by second, according to oxygen saturation (SpO2), heart rate and respiratory rate measured by a pulse oximeter.
Adults with acute respiratory failure admitted to the Respiratory Intermediate Care Unit (RICU) of Hospital Universitario Fundación Jiménez Díaz (Madrid, Spain) receive oxygen titrated automatically by EMILY.AI and, in the same monitoring session, oxygen titrated manually by the nursing team while the device records saturation and flow.
The study measures how much of the time patients stay within their target saturation range under each method, how fast the device corrects deviations, the alerts it generates, nursing workload, oxygen use and patient comfort. This substudy is part of clinical investigation FJD-EMILY-23-02, whose other substudies are registered in separate records.
Read the detailed description
Background Oxygen therapy is usually titrated manually. Both hypoxaemia and hyperoxaemia are associated with harm, so keeping patients within a target SpO2 range matters. EMILY.AI combines a medical-grade oxygen valve with an edge-computing fuzzy-logic algorithm that sets the oxygen flow every second from SpO2, heart rate and respiratory rate, with continuous logging of physiological signals, delivered flow and algorithm-recommended flow.
Setting and supervision All sessions take place in the RICU of Hospital Universitario Fundación Jiménez Díaz under continuous supervision by a study physician, with conventional oxygen therapy available as back-up. Patients are classified at inclusion as hypoxaemic (PaCO2 ≤45 mmHg; target SpO2 94-98%) or hypercapnic (PaCO2 >45 mmHg; target SpO2 92-94%). The same patient may take part in more than one session on different days if their oxygen requirement has changed.
Study phases
The substudy has been conducted in successive phases under amendments approved by the Ethics Committee and the Spanish Agency of Medicines and Medical Devices (AEMPS):
- Initial phase (April-August 2025 and December 2025, CIP v3.0-v5.0): EMILY.AI titrated oxygen in closed-loop mode under physician supervision, without a paired manual-control period. A Nonin pulse oximeter was used in 2025; in December 2025 a small group of participants tested the Masimo pulse oximeter before the paired phase.
- Paired phase (January-April 2026, CIP v4.0 and v5.0): each session comprises approximately 5 hours of closed-loop titration by EMILY.AI followed by approximately 5 hours of manual titration by the nursing team, during which the device keeps recording but does not control the flow. Masimo pulse oximeters are used.
- Algorithm adjustment extension (June-July 2026, CIP v6.0 and v7.0): additional participants, with the same paired session, to validate a refinement of the algorithm's control parameters. Analysed separately.
- Minimum-flow adjustment extension (planned, CIP v8.0): approximately 10 additional participants, with the same paired session, to validate an adjustment of the control parameter that sets the minimum oxygen flow in hypoxaemic patients near the lower limit of their target range. Target ranges and eligibility criteria are unchanged.
Participants are not told which period is automatic and which is manual. The investigators and nursing staff are not masked, for safety reasons.
The protocol FJD-EMILY-23-02 also includes substudies in a conventional hospital ward and during exercise (6-minute walk test), registered separately.
- Conditions
- Chronic Respiratory Failure, Acute Respiratory Failure, Hypoxemic Respiratory Failure, Hypercapnic Respiratory Failure, Acute-on-chronic Respiratory Failure
- Being tested
- Emily.AI, Manual oxygen titration
- Keywords
- Respiratory failure, Hypoxia, Oxigenotherapy, automated oxygen titration, Hiperoxia, closed-loop oxygen therapy
- Medical subject headings
- Respiratory Insufficiency, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emily.AIDevice
Investigational smart oxygen valve with an embedded fuzzy-logic algorithm that adjusts oxygen flow every second from pulse-oximetry SpO2, heart rate and respiratory rate to keep SpO2 within a target range. Other names: EMILY.AI Smart Valve
Manual oxygen titrationOther
Standard care: oxygen flow set and adjusted by the unit's nursing team according to usual practice. The EMILY.AI device stays connected and records signals and flow but does not control delivery.
| Study group | Role | What they receive |
|---|---|---|
| Paired phase: closed-loop then manual titration | Experimental | Participants enrolled January-April 2026 (CIP v4.0-v5.0). Same session: ~5 h closed-loop titration by EMILY.AI, then ~5 h manual titration by nursing staff with the device recording only. Receives: Device: Emily.AI; Other: Manual oxygen titration |
| Extension: adjusted control parameters (slow controller) | Experimental | Participants enrolled June-July 2026 (CIP v6.0). Same paired session, with refined algorithm control parameters. Receives: Device: Emily.AI; Other: Manual oxygen titration |
| Extension: adjusted minimum-flow parameter | Experimental | Approximately 10 participants (CIP v8.0). Same paired session, with an adjusted minimum-flow parameter for hypoxaemic patients. Receives: Device: Emily.AI; Other: Manual oxygen titration |
| Initial phase: closed-loop only | Experimental | Participants enrolled April-August 2025 and December 2025 (CIP v3.0-v5.0). EMILY.AI titrates oxygen in closed-loop mode under continuous physician supervision; no paired manual period. Nonin pulse oximeter in 2025; Masimo pulse oximeter in December 2025. Receives: Device: Emily.AI |
What is being measured
The primary outcome is the main question the study is designed to answer.
EFFICACY - EVALUATION OF THE RATE THE DEVICE MAINTAINS BLOOD OXYGEN SATURATION LEVELS
Percentage of monitored time with SpO2, measured by pulse oximetry, within the predefined target range (hypoxaemic patients 94-98%; hypercapnic patients 92-94%), without delivering less or more oxygen than required. Compared between the closed-loop period (EMILY.AI) and the manual titration period in the same participant.
Measured: During the monitoring session: approximately 5 hours of closed-loop titration followed by approximately 5 hours of manual titration on the same day (closed-loop period only in the initial phase).
Secondary outcomes (9)
ACCURACY - MEASUREMENT OF THE SYSTEM'S ACTION SPEED CORRECTING THE OXYGEN SATURATION LEVELS
Time in seconds from 1) detection of SpO2 outside the target range to the start of correction and 2) the return of SpO2 to the target range.
Measured: During the monitoring session: approximately 5 hours of closed-loop titration followed by approximately 5 hours of manual titration on the same day (closed-loop period only in the initial phase).
ALERT SYSTEM - MEASUREMENT OF THE NUMBER OF SYSTEM ALERTS
Number of alerts generated by EMILY.AI for changes in the oxygen saturation of monitored patients.
Measured: During the monitoring session: approximately 5 hours of closed-loop titration followed by approximately 5 hours of manual titration on the same day (closed-loop period only in the initial phase).
ALERT SYSTEM - EVALUATION OF THE AUTHENTICITY OF THE SYSTEM ALERTS BY COMPARING THE OXYGEN SATURATION LEVELS WITH A CONVENTIONAL SYSTEM
Proportion of alerts confirmed by the conventional monitor and, in case of discrepancy, by arterial blood gas analysis.
Measured: During the monitoring session: approximately 5 hours of closed-loop titration followed by approximately 5 hours of manual titration on the same day (closed-loop period only in the initial phase).
EFFICIENCY - MEASUREMENT OF THE NUMBER OF TIMES THE MEDICAL AND NURSING TEAM MUST ADJUST THE OXYGENATION
Number of nursing or medical interventions to adjust oxygen flow or address oxygenation-related symptoms, compared between the closed-loop and manual periods.
Measured: During the monitoring session: approximately 5 hours of closed-loop titration followed by approximately 5 hours of manual titration on the same day (closed-loop period only in the initial phase).
VERSATILITY - COMPARISON OF BLOOD OXYGEN SATURATION LEVELS MAINTENANCE BETWEEN DIFFERENT PROFILES AND SITUATIONS
Percentage of time within the target range compared between hypoxaemic and hypercapnic participants and across clinical situations (bed rest, sitting, eating, physiotherapy).
Measured: During the monitoring session: approximately 5 hours of closed-loop titration followed by approximately 5 hours of manual titration on the same day (closed-loop period only in the initial phase).
SAFETY - TIME WITH OXYGEN SATURATION BELOW AND ABOVE THE TARGET RANGE
Percentage of monitored time with SpO2 below and above the target range, as indicators of insufficient or excessive oxygen delivery, compared between periods.
Measured: During the monitoring session: approximately 5 hours of closed-loop titration followed by approximately 5 hours of manual titration on the same day (closed-loop period only in the initial phase).
EFFICIENCY - OXYGEN FLOW DELIVERED
Mean delivered oxygen flow (L/min), distinguishing flow delivered while SpO2 was above the target range, compared between periods.
Measured: During the monitoring session: approximately 5 hours of closed-loop titration followed by approximately 5 hours of manual titration on the same day (closed-loop period only in the initial phase).
CLINICAL BENEFIT - DYSPNOEA, ACTIVITY TOLERANCE, COMFORT AND SATISFACTION
Participant-reported dyspnoea and tolerance during hygiene, meals and physiotherapy, comfort and satisfaction, measured with Likert-scale questionnaires.
Measured: During the monitoring session: approximately 5 hours of closed-loop titration followed by approximately 5 hours of manual titration on the same day (closed-loop period only in the initial phase).
ADAPTABILITY - AGREEMENT BETWEEN PULSE OXIMETER MODELS
Agreement of SpO2 measurements and trends between pulse oximeter models (Nonin, Masimo, Nihon Kohden); acceptable when variability is below 10% and does not affect patient management.
Measured: During the monitoring session: approximately 5 hours of closed-loop titration followed by approximately 5 hours of manual titration on the same day (closed-loop period only in the initial phase).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start15 Apr 2025
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Why it stopped: Recruitment temporarily paused pending competent authority (AEMPS) approval of a protocol amendment. Recruitment will resume after approval. Not stopped for safety reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Respiratory FailureStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Participants are enrolled in successive phases defined by protocol amendments. In the initial phase, participants received closed-loop titration only. In the subsequent phases, each participant receives, within the same monitoring session and in a fixed order, approximately 5 hours of closed-loop titration by EMILY.AI followed by approximately 5 hours of manual titration by nursing staff, with the device recording throughout. Later phases test adjusted algorithm control parameters.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aether Tech S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Universitario Fundación Jiménez Díaz
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952816
- Sponsor's protocol ID
- FJD-EMILY-23-02-UCIR
- Other IDs
- FJD-EMILY-23-02
- Status last verified
- Oct 2026
- First submitted
- 8 Apr 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional, Clinical, and Predictive Validation Study of the EMILY AI Device in Patients With Acute and Chronic Respiratory Failure: Respiratory Intermediate Care Unit Substudy
- ClinicalTrials.gov ID
- NCT06952816
- Acronym / sponsor ID
- FJD-EMILY-23-02-UCIR
- Conditions
- Chronic Respiratory Failure, Acute Respiratory Failure, Hypoxemic Respiratory Failure, Hypercapnic Respiratory Failure, Acute-on-chronic Respiratory Failure
- Keywords
- Respiratory failure, Hypoxia, Oxigenotherapy, automated oxygen titration, Hiperoxia, closed-loop oxygen therapy
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Recruitment temporarily paused pending competent authority (AEMPS) approval of a protocol amendment. Recruitment will resume after approval. Not stopped for safety reasons.
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Aether Tech S.L.Industry (pharma, biotech, devices)
- Collaborators
- Hospital Universitario Fundación Jiménez Díaz
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 1 May 2025 (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.
This study evaluates EMILY.AI, an investigational (non-CE-marked) smart oxygen valve that automatically adjusts the oxygen flow delivered to a patient, second by second, according to oxygen saturation (SpO2), heart rate and respiratory rate measured by a pulse oximeter.
Adults with acute respiratory failure admitted to the Respiratory Intermediate Care Unit (RICU) of Hospital Universitario Fundación Jiménez Díaz (Madrid, Spain) receive oxygen titrated automatically by EMILY.AI and, in the same monitoring session, oxygen titrated manually by the nursing team while the device records saturation and flow.
The study measures how much of the time patients stay within their target saturation range under each method, how fast the device corrects deviations, the alerts it generates, nursing workload, oxygen use and patient comfort. This substudy is part of clinical investigation FJD-EMILY-23-02, whose other substudies are registered in separate records.
Detailed description
Background Oxygen therapy is usually titrated manually. Both hypoxaemia and hyperoxaemia are associated with harm, so keeping patients within a target SpO2 range matters. EMILY.AI combines a medical-grade oxygen valve with an edge-computing fuzzy-logic algorithm that sets the oxygen flow every second from SpO2, heart rate and respiratory rate, with continuous logging of physiological signals, delivered flow and algorithm-recommended flow.
Setting and supervision All sessions take place in the RICU of Hospital Universitario Fundación Jiménez Díaz under continuous supervision by a study physician, with conventional oxygen therapy available as back-up. Patients are classified at inclusion as hypoxaemic (PaCO2 ≤45 mmHg; target SpO2 94-98%) or hypercapnic (PaCO2 >45 mmHg; target SpO2 92-94%). The same patient may take part in more than one session on different days if their oxygen requirement has changed.
Study phases
The substudy has been conducted in successive phases under amendments approved by the Ethics Committee and the Spanish Agency of Medicines and Medical Devices (AEMPS):
- Initial phase (April-August 2025 and December 2025, CIP v3.0-v5.0): EMILY.AI titrated oxygen in closed-loop mode under physician supervision, without a paired manual-control period. A Nonin pulse oximeter was used in 2025; in December 2025 a small group of participants tested the Masimo pulse oximeter before the paired phase.
- Paired phase (January-April 2026, CIP v4.0 and v5.0): each session comprises approximately 5 hours of closed-loop titration by EMILY.AI followed by approximately 5 hours of manual titration by the nursing team, during which the device keeps recording but does not control the flow. Masimo pulse oximeters are used.
- Algorithm adjustment extension (June-July 2026, CIP v6.0 and v7.0): additional participants, with the same paired session, to validate a refinement of the algorithm's control parameters. Analysed separately.
- Minimum-flow adjustment extension (planned, CIP v8.0): approximately 10 additional participants, with the same paired session, to validate an adjustment of the control parameter that sets the minimum oxygen flow in hypoxaemic patients near the lower limit of their target range. Target ranges and eligibility criteria are unchanged.
Participants are not told which period is automatic and which is manual. The investigators and nursing staff are not masked, for safety reasons.
The protocol FJD-EMILY-23-02 also includes substudies in a conventional hospital ward and during exercise (6-minute walk test), registered separately.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Participants are enrolled in successive phases defined by protocol amendments. In the initial phase, participants received closed-loop titration only. In the subsequent phases, each participant receives, within the same monitoring session and in a fixed order, approximately 5 hours of closed-loop titration by EMILY.AI followed by approximately 5 hours of manual titration by nursing staff, with the device recording throughout. Later phases test adjusted algorithm control parameters.
| Arm | Type | Receives |
|---|---|---|
| Paired phase: closed-loop then manual titration | Experimental | Device: Emily.AI, Other: Manual oxygen titrationParticipants enrolled January-April 2026 (CIP v4.0-v5.0). Same session: ~5 h closed-loop titration by EMILY.AI, then ~5 h manual titration by nursing staff with the device recording only. |
| Extension: adjusted control parameters (slow controller) | Experimental | Device: Emily.AI, Other: Manual oxygen titrationParticipants enrolled June-July 2026 (CIP v6.0). Same paired session, with refined algorithm control parameters. |
| Extension: adjusted minimum-flow parameter | Experimental | Device: Emily.AI, Other: Manual oxygen titrationApproximately 10 participants (CIP v8.0). Same paired session, with an adjusted minimum-flow parameter for hypoxaemic patients. |
| Initial phase: closed-loop only | Experimental | Device: Emily.AIParticipants enrolled April-August 2025 and December 2025 (CIP v3.0-v5.0). EMILY.AI titrates oxygen in closed-loop mode under continuous physician supervision; no paired manual period. Nonin pulse oximeter in 2025; Masimo pulse oximeter in December 2025. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women over 18 years of age or older.
- Admitted to the Respiratory Intermediate Care Unit with acute respiratory failure, defined as baseline arterial PaO2 below 60 mmHg or the need for supplemental oxygen to maintain SpO2 above 90%. Patients on long-term oxygen therapy are eligible if a clinical deterioration requires a higher-than-usual oxygen flow to maintain SpO2 above 90%.
- Spontaneous breathing without positive-pressure ventilatory support (invasive or non-invasive mechanical ventilation, or CPAP) for at least 8 consecutive hours.
- Able to understand the study and sign informed consent.
Key exclusion criteria (7 listed)
- Hemodynamic instability or need for vasoactive drugs.
- Severe temperature changes (axillary temperature above 39 °C or below 35 °C).
- Hemoglobinopathies or severe anemia (hemoglobin below 7 g/dL).
- Severe acidosis (pH below 7.20) or severe alkalosis (pH above 7.55).
- Anatomical abnormalities preventing correct placement of the pulse oximeter.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emily.AIInvestigational smart oxygen valve with an embedded fuzzy-logic algorithm that adjusts oxygen flow every second from pulse-oximetry SpO2, heart rate and respiratory rate to keep SpO2 within a target range. Other names: EMILY.AI Smart Valve | Device | Extension: adjusted control parameters (slow controller), Extension: adjusted minimum-flow parameter, Initial phase: closed-loop only, Paired phase: closed-loop then manual titration |
| Manual oxygen titrationStandard care: oxygen flow set and adjusted by the unit's nursing team according to usual practice. The EMILY.AI device stays connected and records signals and flow but does not control delivery. | Other | Extension: adjusted control parameters (slow controller), Extension: adjusted minimum-flow parameter, Paired phase: closed-loop then manual titration |
Primary outcome
EFFICACY - EVALUATION OF THE RATE THE DEVICE MAINTAINS BLOOD OXYGEN SATURATION LEVELS
Time frame: During the monitoring session: approximately 5 hours of closed-loop titration followed by approximately 5 hours of manual titration on the same day (closed-loop period only in the initial phase).
Percentage of monitored time with SpO2, measured by pulse oximetry, within the predefined target range (hypoxaemic patients 94-98%; hypercapnic patients 92-94%), without delivering less or more oxygen than required. Compared between the closed-loop period (EMILY.AI) and the manual titration period in the same participant.
9 secondary outcomes
ACCURACY - MEASUREMENT OF THE SYSTEM'S ACTION SPEED CORRECTING THE OXYGEN SATURATION LEVELS
Time frame: During the monitoring session: approximately 5 hours of closed-loop titration followed by approximately 5 hours of manual titration on the same day (closed-loop period only in the initial phase).
ALERT SYSTEM - MEASUREMENT OF THE NUMBER OF SYSTEM ALERTS
Time frame: During the monitoring session: approximately 5 hours of closed-loop titration followed by approximately 5 hours of manual titration on the same day (closed-loop period only in the initial phase).
ALERT SYSTEM - EVALUATION OF THE AUTHENTICITY OF THE SYSTEM ALERTS BY COMPARING THE OXYGEN SATURATION LEVELS WITH A CONVENTIONAL SYSTEM
Time frame: During the monitoring session: approximately 5 hours of closed-loop titration followed by approximately 5 hours of manual titration on the same day (closed-loop period only in the initial phase).
EFFICIENCY - MEASUREMENT OF THE NUMBER OF TIMES THE MEDICAL AND NURSING TEAM MUST ADJUST THE OXYGENATION
Time frame: During the monitoring session: approximately 5 hours of closed-loop titration followed by approximately 5 hours of manual titration on the same day (closed-loop period only in the initial phase).
VERSATILITY - COMPARISON OF BLOOD OXYGEN SATURATION LEVELS MAINTENANCE BETWEEN DIFFERENT PROFILES AND SITUATIONS
Time frame: During the monitoring session: approximately 5 hours of closed-loop titration followed by approximately 5 hours of manual titration on the same day (closed-loop period only in the initial phase).
SAFETY - TIME WITH OXYGEN SATURATION BELOW AND ABOVE THE TARGET RANGE
Time frame: During the monitoring session: approximately 5 hours of closed-loop titration followed by approximately 5 hours of manual titration on the same day (closed-loop period only in the initial phase).
EFFICIENCY - OXYGEN FLOW DELIVERED
Time frame: During the monitoring session: approximately 5 hours of closed-loop titration followed by approximately 5 hours of manual titration on the same day (closed-loop period only in the initial phase).
CLINICAL BENEFIT - DYSPNOEA, ACTIVITY TOLERANCE, COMFORT AND SATISFACTION
Time frame: During the monitoring session: approximately 5 hours of closed-loop titration followed by approximately 5 hours of manual titration on the same day (closed-loop period only in the initial phase).
ADAPTABILITY - AGREEMENT BETWEEN PULSE OXIMETER MODELS
Time frame: During the monitoring session: approximately 5 hours of closed-loop titration followed by approximately 5 hours of manual titration on the same day (closed-loop period only in the initial phase).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emily.AI and Manual oxygen titration in people with Chronic Respiratory Failure and Acute Respiratory Failure, run by Aether Tech S.L. at 1 site in Spain.
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 4 inclusion and 7 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: paused, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EFFICACY - EVALUATION OF THE RATE THE DEVICE MAINTAINS BLOOD OXYGEN SATURATION LEVELS (time frame: During the monitoring session: approximately 5 hours of closed-loop titration followed by approximately 5 hours of manual titration on the same day (closed-loop period only in the initial phase).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2026.