Accuracy of Smartwatches in Measuring Oxygen Levels in Patients With Pulmonary Hypertension: A Pilot Study

NCT07311135 | Recruiting

• 1 other identifier: 25/CARD/03
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to learn how accurate smartwatches are at measuring oxygen levels in patients with a condition called pulmonary hypertension. The main questions it aims to answer are:

• How accurate the smartwatches are at measuring oxygen levels when the patient is sitting at rest
• How accurate are smartwatches at measuring oxygen levels after exercise
• How accurate are smartwatches at measuring oxygen levels after breathing a lower level of oxygen through a mask. Researchers will compare oxygen levels measured through a smartwatch with those checked through a finger probe oxygen monitor and also from a blood sample checked from the artery in the wrist to see if smartwatch oxygen measurements are similar. Participants will:
• Attend the hospital once, just for a few hours to collect all the required data.

Conditions

Pulmonary Hypertension

Keywords

smartwatch; pulmonary hypertension; oxygen saturations; SpO2

Outcome Measures

Primary Outcomes (1)

• Agreement of oxygen saturations (SpO2) measured by the wrist-worn pulse oximeter when compared with arterial blood gas oxygen saturations (SaO2) at rest

  SpO2 (measured by the wrist-worn pulse oximeter (smartwatch) and standard fingerprobe pulse oximeter) and SaO2 (measured by the arterial blood gas analysis) measured as a percentage.

  1 study visit, anticipated to be around 3 hours.

Secondary Outcomes (2)

• 1. Agreement of oxygen saturations (SpO2) measured by the wrist-worn pulse oximeter when compared with arterial blood gas oxygen saturations (SaO2) after exercise

  1 study visit, estimated 3 hours duration

• 1. Agreement of oxygen saturations (SpO2) measured by the wrist-worn pulse oximeter when compared with arterial blood gas oxygen saturations (SaO2) after a hypoxic challenge

  1 study visit, estimated 3 hours duration

Study Arms (1)

Adult patients with pulmonary hypertension

Pre-capillary pulmonary hypertension, able to complete a six-minute walk test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients attending outpatient clinic at the Golden Jubilee National Hospital under the care of the Scottish Pulmonary Vascular Unit.

You may qualify if:

• Aged 18-years old and above.
• Diagnosed with pulmonary hypertension by right heart catheterisation showing a baseline mean pulmonary artery pressure \> 20mmHg, PVR \>2 Woods Units.
• Able to perform a six-minute walk test (6MWT)
• Able to give written informed consent.

You may not qualify if:

• Peripheral arterial disease
• Tattoos or skin markings which cover the dorsal wrist.
• Resting SpO2 \<88%
• Severe concurrent medical condition that would prevent participation in study procedures or with life expectancy \<3 months
• Patients with bleeding disorders
• Patients on anticoagulation
• Except in circumstances where anticoagulation is given solely for historical perceived long term survival benefit for pulmonary arterial hypertension. This patient group could be given the option to come off their anticoagulation for 1 week prior to the study visit if they wished to take part in the study. It could then be restarted the day following the study visit providing there were no bleeding complications related to the arterial line.

Sponsors & Collaborators

• Golden Jubilee National Hospital: lead

Study Sites (1)

Golden Jubilee National Hospital

Glasgow, G81 4DY, United Kingdom

RECRUITING

Related Publications (3)

• Spaccarotella C, Polimeni A, Mancuso C, Pelaia G, Esposito G, Indolfi C. Assessment of Non-Invasive Measurements of Oxygen Saturation and Heart Rate with an Apple Smartwatch: Comparison with a Standard Pulse Oximeter. J Clin Med. 2022 Mar 8;11(6):1467. doi: 10.3390/jcm11061467.

  PMID: 35329793 BACKGROUND

• Pipek LZ, Nascimento RFV, Acencio MMP, Teixeira LR. Comparison of SpO2 and heart rate values on Apple Watch and conventional commercial oximeters devices in patients with lung disease. Sci Rep. 2021 Sep 23;11(1):18901. doi: 10.1038/s41598-021-98453-3.

  PMID: 34556765 BACKGROUND

• Arslan B, Sener K, Guven R, Kapci M, Korkut S, Sutasir MN, Tekindal MA. Accuracy of the Apple Watch in measuring oxygen saturation: comparison with pulse oximetry and ABG. Ir J Med Sci. 2024 Feb;193(1):477-483. doi: 10.1007/s11845-023-03456-w. Epub 2023 Jul 13.

  PMID: 37440093 BACKGROUND

Related Links

• US FDA Pulse oximeter premarket notification submissions- Guidance for Industry and Food and Drug Administration Staff. 2013
• US FDA Pulse oximeter premarket notification submissions- Guidance for Industry and Food and Drug Administration Staff. 2025 DRAFT Document

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Martin Johnson, BA, MBChB(Hons), MD, FRCP

  Golden Jubilee National Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Johnson, BA, MBChB(Hons), MD, FRCP

CONTACT

(0044) 0141 951 5497; martin.johnson@nhs.scot

Jamie Ingram, MBChB, BMSc, PGCert

CONTACT

(0044) 0141 951 5497; jamie.ingram2@nhs.scot

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 30, 2025
• Study Start: December 17, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)