Validation of a Miniature SpO2 Sensor in Healthy Subjects and Patients With Long-term Oxygen Therapy.

Validation of a Miniature SpO2 Sensor in Healthy Subjects and Patients With Long-term Oxygen Therapy. A Prospective, Method Comparison, Proof of Concept Study.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02723032

Acronym

OxyFrame

Enrollment

Registered

2016-03-30

Start date

2016-03-31

Completion date

2016-05-31

Last updated

2016-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxemia, Long Term Oxygen Therapy, Pulse Oximeter Validation

Brief summary

By integrating a miniaturized pulse oximetry sensor into the frame of oxygen delivery glasses which dissimulates the nasal cannula, the investigators hope to optimize and long term oxygen therapy (LTOT) regarding medical and social aspects. The validation of the novel SpO2 sensor is the first step in the concept of personalized, dynamic delivery of oxygen by eyeglasses using a closed-loop system.

Detailed description

Objectives: 1. To determine accuracy of SpO2 measurements by the novel sensor compared to 2 reference pulse oximeters in healthy subjects undergoing a normobaric hypoxic challenge provoking SpO2 desaturation. 2. To determine accuracy of SpO2 measurements by the novel sensor compared to 2 reference pulse oximeters and to arterial blood gas analysis in patients qualifying for LTOT, breathing room air at rest (lying, sitting, standing position) and during exercise (slow walking, 6-MWT, ergometer cycle).

Interventions

DEVICEOxyFrame

Validation of a miniaturized pulse oximetry sensor for integration into the frame of oxygen delivery glasses.

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Healthy volunteers Inclusion Criteria: * Age 18 - 60 years, * Non smoker, * Good general health and physical fitness * Informed Consent

Exclusion criteria

* Current or history of tobacco smoking (\> 5 py) * Current alcohol or drug abuse * Heart disease or untreated arterial hypertension * Pulmonary disease * Epilepsy or other major neurologic disease * Dark skin colour * Known anemia * Severe metabolic disease (e.g. diabetes) * Pregnancy Patients Inclusion Criteria: * Age ≥ 18 years * Long term oxygen therapy at rest and/or on physical effort * Hypoxemia in arterial blood gas analysis at rest PaO2 ≤ 55 mmHg or \< 60 mmHg with PHT or polycythemia (men Hb \> 174 g/L, women Hb \> 140 g/L) or: Oxygen desaturation on effort (SpO2 \< 90%) * Pulmonary disease including Chronic Obstructive Pulmonary Disease, Interstitial Lung Disease and Sarcoidosis * Informed Consent

Design outcomes

Primary

Measure	Time frame	Description
Assessment of accuracy in patients	At baseline	Assessment of the accuracy of the novel pulse oximeter sensor in patients qualifying for LTOT over the entire saturation range by calculating accuracy root mean square (ARMS). Continuous SpO2 measurement of the novel pulse oximeter will be compared to measurements assessed by 2 standard pulse oximeters and arterial blood gas analysis.

Secondary

Measure	Time frame	Description
Assessment of accuracy in healthy volunteers	At baseline	Assessment of accuracy of the novel pulse oximeter sensor in healthy subjects undergoing a normobaric hypoxic challenge provoking SpO2 desaturation. SpO2 will be measured continuously over the hole procedure and SpO2 range by the novel pulse oximeter sensor and the 2 reference pulse oximeters.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026