Validation of a Miniature SpO2 Sensor in Healthy Subjects and Patients With Long-term Oxygen Therapy. (NCT02723032)

Study 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.

Read the detailed description

Objectives:

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.
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).

Conditions studied

Pulse Oximeter Validation
Long Term Oxygen Therapy
Hypoxemia

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Hypoxia 1,231

In context

Hypoxia

1,231 studies on the registry are indexed under Hypoxia; 241 are open to participants now.

This study's enrollment of 36 is below the median of 45 across 853 interventional studies indexed under Hypoxia.

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Lead sponsor

Insel Gruppe AG, University Hospital Bern is the lead sponsor of 724 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Eligibility 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

Exclusion Criteria:

Severe hypoxemia (pO2 \<40 mmHg)
Severe hypercapnia (pCO2 >55 mmHg)
Acute respiratory infection or systemic infection,
Severe systolic heart disease (LVEF \< 25%)
Myocardial infarction during the last month before inclusion
Unstable angina pectoris
Severe aortic stenosis (mean gradient > 40mmHg, valve area \<1 cm2)
Rhythmogenic heart disease
Severe or untreated arterial hypertension (blood pressure > 180mmHg systolic, >100mmHg diastolic)
Anemia (Hb \< 120 g/l)
Known or suspected coagulation disorder (e.g. INR > 4)
Severe or untreated metabolic disorder
Neurologic disease or dementia
Pregnancy
History of non-compliance to medical treatment
Current alcohol, drug abuse or current tobacco smoking
Dark skin color

Study design

Phase: Not applicable
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 36 participants (actual)

Study arms

Other
Healthy Subjects and patients
Validation of SpO2 sensor in healthy subjects as a first step. Validation of SpO2 sensor in patients as a second step.
Device: OxyFrame

Interventions

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

What researchers measure

Primary outcomes

Assessment of accuracy in patients
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.
Time frame: At baseline

Secondary outcomes

Assessment of accuracy in healthy volunteers
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.
Time frame: At baseline

Study locations

1 site

Department of Pulmonary Medicine, University Hospital Bern
Bern, 3010, Switzerland

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 27, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02723032
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Responsible party: Sponsor
First posted: Mar 30, 2016
Start date: Mar 2016
Primary completion: Apr 2016
Completion: May 2016
Last update: Oct 27, 2016

Study contacts

Manuela Funke, MD

principal investigator · Department of Pulmonary Medicine, University Hospital Bern

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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