COPD Acute ExacerbationCHABLISNCT07361744
Change in Sleep Breathing During Hospital Admission for COPD Exacerbation
An observational study of COPD Acute Exacerbation, run by Asten Sante at 1 site in France.
Trial summary
hronic obstructive pulmonary disease (COPD) is a common lung disease that can worsen suddenly, leading to hospital admission. During these exacerbations, breathing becomes unstable and recovery is difficult to predict. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD Acute Exacerbation
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 9 Dec 2025to 1 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The study population consists of adult patients with a confirmed diagnosis of chronic obstructive pulmonary disease (COPD) who are hospitalized for an acute exacerbation. Eligible participants are included within the first 24 hours of admission to an acute medical ward and are able to provide informed consent. All participants have COPD diagnosed by spirometry according to standard criteria and are admitted for management of an exacerbation not requiring invasive or non-invasive mechanical ventilation at the time of inclusion. Patients receiving long-term positive airway pressure therapy or home non-invasive ventilation are excluded. The study population reflects a real-life hospitalized COPD cohort, encompassing a range of disease severity, clinical trajectories, and comorbidities commonly observed during acute exacerbations. Participants are followed during hospitalization and up to six weeks after discharge to characterize changes in nocturnal ventilatory patterns during recovery.
Who may be able to join
- Adults (≥ 18 years) with a confirmed diagnosis of chronic obstructive pulmonary disease (COPD) based on spirometry
- Hospitalized for an acute exacerbation of COPD for less than 24 hours at the time of inclusion
- Admitted to an acute medical ward
- Able to provide written informed consent
- Affiliated with the national health insurance system
Who cannot join
- Ongoing invasive or non-invasive mechanical ventilation at the time of inclusion
- Long-term non-invasive ventilation or positive airway pressure therapy prior to hospitalization
- Use of an anti-pressure (anti-decubitus) mattress incompatible with the study devices
- Severe anxiety disorders interfering with study procedures
- Known allergy to materials used for sensor placement
- Pregnancy or breastfeeding
- Minor or legally protected adult (guardianship, curatorship) or deprivation of liberty
- Lack of health insurance coverage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Change in Breathing During Hospital Admission for COPD Exacerbation
hronic obstructive pulmonary disease (COPD) is a common lung disease that can worsen suddenly, leading to hospital admission. During these exacerbations, breathing becomes unstable and recovery is difficult to predict. Currently, doctors lack simple tools to monitor how patients recover day by day during hospitalization and after discharge.
This observational study aims to describe how breathing patterns during sleep change over time in patients hospitalized for a COPD exacerbation. Breathing will be monitored using standard sleep recordings and a non-contact sensor placed under the mattress, which measures breathing without disturbing the patient.
By better understanding how nocturnal breathing variability evolves during recovery, this study may help identify early signs of improvement or deterioration, support safer hospital discharge decisions, and improve follow-up after hospitalization for COPD exacerbation
- Conditions
- COPD Acute Exacerbation
- Keywords
- sleep, breathing variability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| COPD acute exacerbations | Consecutive patients admitted in a medicine hospital department for acute exacerbation of COPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nocturnal ventilatory variability during sleep assessed by polysomnography
Nocturnal ventilatory variability will be quantified during sleep using polysomnography. Variability will be assessed on a breath-by-breath basis using 30-second analysis windows and summarized by the following predefined indice SD.
SD will be calculated separately for each sleep stage (N1, N2, N3, REM) and then averaged across total sleep time for each recording night.
Measured: Baseline (first night after hospitalization), Day 3 of hospitalization, Day 7 of hospitalization or the day before discharge (if discharge occurs earlier), and 6 weeks after hospital discharge (study completion)
Secondary outcomes (5)
Nocturnal ventilatory variability assessed by a non-contact respiratory sensor
Nocturnal ventilatory variability will be assessed using a non-contact respiratory sensor (Withings Sleep Analyzer). Variability will be quantified using the same predefined indice derived from polysomnography SD.
Indice will be calculated on 30-second windows during overnight recordings and averaged across total sleep time for each night.
Measured: Nightly during hospitalization (up to 7 days) and during one overnight recording at 6 weeks after hospital discharge
Correlation between nocturnal ventilatory variability and clinical worsening during hospitalization
Clinical worsening during hospitalization will be assessed as a binary outcome (clinical worsening: yes/no), defined by the occurrence of at least one of the following events:
escalation of respiratory support, transfer to intensive care, need for non-invasive or invasive mechanical ventilation, in-hospital death. Nocturnal ventilatory variability will be quantified using polysomnography-derived SD1. The correlation between ventilatory variability indice and clinical worsening status will be evaluated.
Measured: From baseline (first night after hospitalization) through Day 7 of hospitalization or the day before discharge (maximum hospitalization duration: 7 days)
Correlation between nocturnal ventilatory variability and physician-assessed readiness for hospital discharge
Physician-assessed readiness for hospital discharge will be evaluated daily during hospitalization as a binary variable (ready for discharge: yes/no), based on routine clinical judgment documented in the medical record.
Nocturnal ventilatory variability will be assessed using SD1 derived from overnight respiratory recordings obtained by polysomnography on scheduled nights and by a non-contact respiratory sensor during hospitalization.
The correlation between ventilatory variability indices and physician-assessed readiness for discharge will be evaluated.
Measured: Daily from baseline (first night after hospitalization) until hospital discharge (up to 7 days)
Association between nocturnal ventilatory variability and 28-day hospital readmission
Hospital readmission will be assessed as a binary outcome (readmitted: yes/no) within 28 days following discharge from the index hospitalization.
Nocturnal ventilatory variability will be quantified during hospitalization using SD1. The association between ventilatory variability indices and 28-day hospital readmission will be assessed using regression models, and results will be expressed as odds ratios per 1-unit increase in each variability index.
Measured: Up to 28 days after hospital discharge
Correlation between nocturnal ventilatory variability and daytime ventilatory drive assessed by parasternal electromyography
Daytime ventilatory drive will be assessed using parasternal electromyography (EMGpara) recorded during wakefulness with surface electrodes, as part of routine physiological assessment. EMGpara measurements will be obtained at predefined time points during the index hospitalization and at follow-up.
The relationship between nocturnal ventilatory variability and daytime ventilatory drive will be evaluated using correlation analyses and mixed-effects models accounting for repeated measurements within participants.
Measured: Day 1, Day 3, Day 7 (or the night before discharge if discharge occurs earlier), and 6 weeks after hospital discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start9 Dec 2025
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD Acute ExacerbationStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asten Sante
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pitié-Salpêtrière Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07361744
- Sponsor's protocol ID
- 2024-A02121-46
- Acronym
- CHABLIS
- Status last verified
- Jan 2026
- First submitted
- 15 Dec 2025
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change in Breathing During Hospital Admission for COPD Exacerbation
- ClinicalTrials.gov ID
- NCT07361744
- Acronym / sponsor ID
- CHABLIS / 2024-A02121-46
- Conditions
- COPD Acute Exacerbation
- Keywords
- sleep, breathing variability
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Asten SanteIndustry (pharma, biotech, devices)
- Collaborators
- Pitié-Salpêtrière Hospital
- Study start
- 9 Dec 2025 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 23 Jan 2026 (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.
hronic obstructive pulmonary disease (COPD) is a common lung disease that can worsen suddenly, leading to hospital admission. During these exacerbations, breathing becomes unstable and recovery is difficult to predict. Currently, doctors lack simple tools to monitor how patients recover day by day during hospitalization and after discharge.
This observational study aims to describe how breathing patterns during sleep change over time in patients hospitalized for a COPD exacerbation. Breathing will be monitored using standard sleep recordings and a non-contact sensor placed under the mattress, which measures breathing without disturbing the patient.
By better understanding how nocturnal breathing variability evolves during recovery, this study may help identify early signs of improvement or deterioration, support safer hospital discharge decisions, and improve follow-up after hospitalization for COPD exacerbation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD acute exacerbations | – | –Consecutive patients admitted in a medicine hospital department for acute exacerbation of COPD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients with a confirmed diagnosis of chronic obstructive pulmonary disease (COPD) who are hospitalized for an acute exacerbation. Eligible participants are included within the first 24 hours of admission to an acute medical ward and are able to provide informed consent. All participants have COPD diagnosed by spirometry according to standard criteria and are admitted for management of an exacerbation not requiring invasive or non-invasive mechanical ventilation at the time of inclusion. Patients receiving long-term positive airway pressure therapy or home non-invasive ventilation are excluded. The study population reflects a real-life hospitalized COPD cohort, encompassing a range of disease severity, clinical trajectories, and comorbidities commonly observed during acute exacerbations. Participants are followed during hospitalization and up to six weeks after discharge to characterize changes in nocturnal ventilatory patterns during recovery.
Key inclusion criteria (5 listed)
- Adults (≥ 18 years) with a confirmed diagnosis of chronic obstructive pulmonary disease (COPD) based on spirometry
- Hospitalized for an acute exacerbation of COPD for less than 24 hours at the time of inclusion
- Admitted to an acute medical ward
- Able to provide written informed consent
- Affiliated with the national health insurance system
Key exclusion criteria (8 listed)
- Ongoing invasive or non-invasive mechanical ventilation at the time of inclusion
- Long-term non-invasive ventilation or positive airway pressure therapy prior to hospitalization
- Use of an anti-pressure (anti-decubitus) mattress incompatible with the study devices
- Severe anxiety disorders interfering with study procedures
- Known allergy to materials used for sensor placement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Nocturnal ventilatory variability during sleep assessed by polysomnography
Time frame: Baseline (first night after hospitalization), Day 3 of hospitalization, Day 7 of hospitalization or the day before discharge (if discharge occurs earlier), and 6 weeks after hospital discharge (study completion)
Nocturnal ventilatory variability will be quantified during sleep using polysomnography. Variability will be assessed on a breath-by-breath basis using 30-second analysis windows and summarized by the following predefined indice SD. SD will be calculated separately for each sleep stage (N1, N2, N3, REM) and then averaged across total sleep time for each recording night.
5 secondary outcomes
Nocturnal ventilatory variability assessed by a non-contact respiratory sensor
Time frame: Nightly during hospitalization (up to 7 days) and during one overnight recording at 6 weeks after hospital discharge
Correlation between nocturnal ventilatory variability and clinical worsening during hospitalization
Time frame: From baseline (first night after hospitalization) through Day 7 of hospitalization or the day before discharge (maximum hospitalization duration: 7 days)
Correlation between nocturnal ventilatory variability and physician-assessed readiness for hospital discharge
Time frame: Daily from baseline (first night after hospitalization) until hospital discharge (up to 7 days)
Association between nocturnal ventilatory variability and 28-day hospital readmission
Time frame: Up to 28 days after hospital discharge
Correlation between nocturnal ventilatory variability and daytime ventilatory drive assessed by parasternal electromyography
Time frame: Day 1, Day 3, Day 7 (or the night before discharge if discharge occurs earlier), and 6 weeks after hospital discharge.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 COPD Acute Exacerbation, run by Asten Sante at 1 site in France.
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 8 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: under way, not looking for participants, as of the sponsor's last update on 23 Jan 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nocturnal ventilatory variability during sleep assessed by polysomnography (time frame: Baseline (first night after hospitalization), Day 3 of hospitalization, Day 7 of hospitalization or the day before discharge (if discharge occurs earlier), and 6 weeks after hospital discharge (study completion)). 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 23 Jan 2026.