Chronic Respiratory DiseaseNCT06525857
Observing Physiological Changes in Patients With Long-term Oxygen Therapy
An observational study of Chronic Respiratory Disease, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Respiratory Disease
- What is being tested?
- LTOT
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2024to 31 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a respiratory disease and newly prescribed LTOT
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Inselspital, Bern University Hospital
Bern, 3010
Sabina Guler, sabina.guler@insel.ch
About this study
Official title: Observing Physiological Changes in Patients With Long-term Oxygen Therapy Via Optical and Accelerometry Signals
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.
- Conditions
- Chronic Respiratory Disease
- Being tested
- LTOT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LTOTOther
Patients with newly prescribed LTOT will be monitored for physiological changes
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate changes from before and during LTOT
Record heart rate (BPM) to compare before and during LTOT
Measured: From 1 week before start of LTOT to 1 month after start of LTOT
Respiratory rate changes from before and during LTOT
Record respiratory rate (breaths per minute) to compare before and during LTOT
Measured: From 1 week before start of LTOT to 1 month after start of LTOT
SpO2 changes from before and during LTOT
Record SpO2 (%) to compare before and during LTOT
Measured: From 1 week before start of LTOT to 1 month after start of LTOT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start1 Jun 2024
- Primary completion1 Jul 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Respiratory DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabina Guler, PD Dr. med., Principal investigator, Universitätsklinik für Pneumologie, Allergologie und klinische Immunologie, Inselspital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525857
- Sponsor's protocol ID
- STD0006706
- Status last verified
- Jul 2024
- First submitted
- 25 Jun 2024
- Last updated
- 29 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observing Physiological Changes in Patients With Long-term Oxygen Therapy Via Optical and Accelerometry Signals
- ClinicalTrials.gov ID
- NCT06525857
- Acronym / sponsor ID
- STD0006706
- Conditions
- Chronic Respiratory Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a respiratory disease and newly prescribed LTOT
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LTOTPatients with newly prescribed LTOT will be monitored for physiological changes | Other | – |
Primary outcome
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Chronic Respiratory Disease
Active, not recruiting
Impact of Exercise on the Complications of Corticosteroids in Patients With GVHD: the RESTART Trial
Graft Vs Host Disease, Acute-graft-versus-host Disease
Recruiting
Lungs on Fire: Wildfire Smoke, Incident Diseases, Susceptible Populations, and Community Values in Canada
Asthma, Chronic Obstructive Pulmonary Disease (COPD)
RecruitingPhase 3
A Non-inferiority Pharmacokinetic and Safety/Tolerability Study of Two Different Doses of Weekly SC Alpha1-PI 15% Compared With Corresponding Standard IV Alpha1-PI in Participants With Alpha1-Antitrypsin Deficiency (AATD)
Alpha 1 Antitrypsin Deficiency
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabina Guler, PD Dr. med. principal investigator
Universitätsklinik für Pneumologie, Allergologie und klinische Immunologie, Inselspital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Respiratory Disease, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sabina Guler, PD Dr. med. (+41 31 66 4 48 92, sabina.guler@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate changes from before and during LTOT (time frame: From 1 week before start of LTOT to 1 month after start of LTOT). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.