Observing Physiological Changes in Patients With Long-term Oxygen Therapy

NCT ID: NCT06525857

Last Updated: 2024-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-01

Study Completion Date

2026-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Respiratory Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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LTOT

Patients with newly prescribed LTOT will be monitored for physiological changes

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sabina Guler, PD Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinik für Pneumologie, Allergologie und klinische Immunologie, Inselspital Bern

Locations

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Inselspital, Bern University Hospital

Bern, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Sabina Guler, PD Dr. med.

Role: CONTACT

+41 31 66 4 48 92

Facility Contacts

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Sabina Guler

Role: primary

Other Identifiers

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STD0006706

Identifier Type: -

Identifier Source: org_study_id

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