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NCT Number: NCT06525857

Observing Physiological Changes in Patients With Long-term Oxygen Therapy

In this project, the investigators aim to assess changes of physiological parameters obtained non-invasively through PPG and accelerometry signals between before and during LTOT (long-term oxygen therapy) and investigate if those changes are different in patients with worsening frailty and/or improving quality of life.

For this, they will record optical (PPG) and accelerometry data via a datalogger on 40 patients undergoing LTOT and assess the PPG-derived physiological signals.

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Key information

Conditions

Chronic Respiratory Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Inselspital, Bern University Hospital

Bern, 3010, Switzerland

Location status: Recruiting

Location contact

Sabina Guler

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18-year-old, and
  • Chronic respiratory disease including a) chronic obstructive pulmonary disease, b) interstitial lung disease, c) pulmonary hypertension, d) bronchiectasis, and
  • Prescribed new LTOT due to a chronic respiratory disease with resting and/or exertional hypoxemia, and
  • Able to speak/read/understand German or French, and
  • Willing and able to understand and provide signed informed consent

Exclusion criteria

  • Pregnant or lactating women, or
  • Inability to follow the procedures/instructions of the study (e.g. due to language, psychological disorders, dementia, etc.), or
  • Patients having a subordination link to the investigators, or
  • Patients with isolated nocturnal oxygen therapy or LTOT prescription for a heart disease, sleep associated breathing disorder, neuromuscular disease or lung cancer, or
  • Known participation in another human research project (ClinO/HRO) that may affect the objectives of this study.

Treatment and study plan

LTOT

Other

Patients with newly prescribed LTOT will be monitored for physiological changes

Primary outcomes

  1. Heart rate changes from before and during LTOT

    Time frame: From 1 week before start of LTOT to 1 month after start of LTOT

    Record heart rate (BPM) to compare before and during LTOT

  2. Respiratory rate changes from before and during LTOT

    Time frame: From 1 week before start of LTOT to 1 month after start of LTOT

    Record respiratory rate (breaths per minute) to compare before and during LTOT

  3. SpO2 changes from before and during LTOT

    Time frame: From 1 week before start of LTOT to 1 month after start of LTOT

    Record SpO2 (%) to compare before and during LTOT

Study contacts

Contact information is provided by the study sponsor or research team.

Sabina Guler, PD Dr. med.

CONTACT

[email protected]

+41 31 66 4 48 92

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

Observing Physiological Changes in Patients With Long-term Oxygen Therapy Via Optical and Accelerometry Signals

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jul 29, 2024
Registry last updated
Jul 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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