COPDHYPONIVNCT07414108
How Nocturnal Hypoventilation Predicts Long-term Response to Non-invasive Ventilation in Hypercapnic COPD Patients
An observational study of COPD and COPD (Chronic Obstructive Pulmonary Disease), run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
The study is an observational, single-center, prospective cohort study aiming to evaluate respiratory mechanics data, as well as clinical and functional parameters commonly used in clinical practice in patients with COPD and hypercapnic respiratory failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, COPD (Chronic Obstructive Pulmonary Disease), Hypercapnia
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 10 Dec 2025to Jun 2028
- 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 patients with COPD and hypercapnic respiratory failure who require NIV and who are evaluated in the outpatient clinic and/or inpatient unit of the Respiratory and Critical Care Unit of the IRCCS AOU of Bologna.
Who may be able to join
- Age ≥ 18 years
- Patients with COPD and hypercapnia, defined as PaCO₂ > 50 mmHg either chronically or 4 weeks after an acute exacerbation requiring invasive or non-invasive mechanical ventilation
- Provision of informed consent
Who cannot join
- Progressive neurodegenerative diseases
- Diaphragmatic disorders
- Severe hemodynamic instability (>1 vasoactive agent for at least 24 hours)
- Acute coronary syndrome (unstable angina / myocardial infarction)
- Severe arrhythmias
- Presence of contraindications to NIV
Show all 10Show fewer
- Cognitive impairment interfering with treatment adherence
- Active and unstable coronary artery disease
- Malignancies undergoing active treatment
- Patients already receiving home non-invasive mechanical ventilation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, 40138
Lara Pisani, PhD, 0512143253, lara.pisani@unibo.it
About this study
Official title: Role of Nocturnal Hypoventilation in Predicting the Long-Term Ventilatory Response in Hypercapnic COPD Patients Treated With Non-Invasive Ventilation: A Prospective Observational Study With Clinical, Functional, and Radiological Assessment
The study is an observational, single-center, prospective cohort study aiming to evaluate respiratory mechanics data, as well as clinical and functional parameters commonly used in clinical practice in patients with COPD and hypercapnic respiratory failure. The study population consists of patients with COPD and hypercapnia requiring NIV. The primary objective of the study is to evaluate the association between the reduction in partial pressure of carbon dioxide in arterial blood (PaCO₂) levels at 6 and 12 months after initiating non-invasive ventilation (NIV) and the presence of nocturnal hypoventilation detected at baseline in patients with COPD and chronic hypercapnia. Secondary objectives of this study are the evaluation of the following parameters measured at baseline and/or after 6 and 12 months of NIV treatment in patients with COPD and chronic hypercapnia:
- Magnitude of esophageal pressure swing during nocturnal monitoring.
- Diaphragm thickness and diaphragmatic thickening fraction assessed by thoracic ultrasound.
- Presence of overlap syndrome (COPD + OSA).
- Radiological classification of COPD subtypes to assess the association between radiological findings, functional profile, severity of nocturnal hypoventilation, and patterns of chronic hypercapnia.
- Respiratory functional parameters, including FEV₁, FVC, FEV₁/FVC ratio, carbon monoxide diffusion capacity (DLCO), and airway resistance (R5 and R20).
- Frequency of severe exacerbations and subsequent rehospitalizations during follow-up.
- Rate of compliance with respiratory treatment.
Read the detailed description
To date, the pathophysiological mechanisms underlying the development of persistent hypercapnia in patients with COPD are not completely understood. Likewise, reliable predictive markers capable of identifying both patients at risk of developing this condition and those who may derive the greatest benefit from long-term non-invasive ventilation (NIV) are still lacking. Early identification of a patient phenotype more responsive to this type of intervention could substantially reduce exacerbations, emergency department visits, hospitalizations, and associated healthcare costs, thereby improving the overall efficiency of the local healthcare system. The aim of this study is therefore to identify more accurate and earlier criteria to recognize patients with COPD and hypercapnic respiratory failure who may benefit from long-term non-invasive ventilatory support, through an integrated analysis of respiratory mechanics data and clinical and functional parameters commonly used in routine clinical practice.
The study population consists of patients with COPD and hypercapnic respiratory failure who require NIV and who are evaluated in the outpatient clinic and/or inpatient unit of the Respiratory and Critical Care Unit of the IRCCS AOU of Bologna. For these patients clinical, functional, and respiratory mechanics data will be collected. Data will be collected at the baseline visit-corresponding to the first visit at the OSAS Ventilated outpatient clinic or the first day of hospitalization in the Pneumology and Respiratory Intensive Care Unit-and during follow-up visits, scheduled according to routine clinical practice at 6 and 12 months after initiation of NIV treatment.
The total duration of the study will be 30 months, including 12 months for patient enrollment, 12 months of follow-up, and 6 months for data analysis.
A total of 25 patients will be included.
- Conditions
- COPD, COPD (Chronic Obstructive Pulmonary Disease), Hypercapnia, Hypercapnic Respiratory Failure, COPD
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypercapnia, Respiratory Insufficiency
What is being measured
The primary outcome is the main question the study is designed to answer.
The association between the reduction in PaCO₂ levels and the presence of nocturnal hypoventilation
The primary outcome is measured through arterial blood gas analysis (ABG) to determine PaCO₂ levels, and through transcutaneous monitoring of oxygen saturation and carbon dioxide (SpO₂ and TcCO₂) to assess the presence of nocturnal hypoventilation.
Nocturnal hypoventilation is defined as an increase in PaCO₂ during sleep (TcCO₂ >10 mmHg above daytime PaCO₂ with TcCO₂ >50 mmHg for at least 10 minutes, or TcCO₂ >55 mmHg for ≥25% of total sleep time).
Measured: PaCO₂ (mmHg), measured by ABG - baseline, 3, 6, and 12 months TcCO₂ (mmHg), measured by transcutaneous monitoring - baseline
Secondary outcomes (11)
Magnitude of esophageal pressure swing during nocturnal monitoring
Placement of a nasogastric respiratory mechanics catheter equipped with an esophageal balloon, and measurement of maximal inspiratory pressure swing (ΔPES).
Measured: Baseline
Diaphragm thickness and diaphragmatic thickening fraction
Assessment of diaphragm thickness variation (TDi-exp, measured from pleural to peritoneal line at end-expiration; normal <1.5 mm suggesting diaphragmatic weakness). Unit of measure: mm
Measured: Baseline
Diaphragmatic thickening fraction
Thickening fraction will be measured with the following formula: TFdi = (inspiratory thickness - expiratory thickness) / expiratory thickness × 100). This outcome will be measure via thoracic ultrasound using a linear probe positioned sagittally along the axillary line at the 8th-9th intercostal space.
Measured: Baseline
Presence of overlap syndrome (COPD + OSA)
Overnight cardiorespiratory monitoring
Measured: Baseline
Radiological classification of COPD subtypes
Data collection from High-resolution computed tomography (HRCT) for morphological evaluation and structural phenotyping (presence or absence of: emphysema, airway-wall thickening, bronchiectasis, air trapping).
Measured: Baseline
Respiratory functional parameters
FEV₁, FVC, FEV₁/FVC ratio measured by spirometry. Unity of measure: L
Measured: Baseline, 6 and 12 months
Respiratory functional parameters
DLCO
Measured: Baseline, 6 and 12 months
Respiratory functional parameters
Resistance at 5 Hz (R5) and Resistance at 20 Hz (R20)
Measured: Baseline, 6 and 12 months
Respiratory functional parameters
6 Minutes Walking Test (6MWT)
Measured: Baseline, 6 and 12 months
Frequency of severe exacerbations
number of hospital admissions, ICU admissions, high-dependency unit admissions, and episodes of acute hypercapnic respiratory failure (AHRF) throughout the study period.
Measured: baseline, 6 and 12 months
Compliance with respiratory treatment
number of nights where the respiratory support has been used for at least 4 hours/night divided by the total number of nights during treatment.
Measured: baseline, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start10 Dec 2025
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- 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
- 25 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07414108
- Sponsor's protocol ID
- HYPONIV
- Other IDs
- 2023.0267
- Acronym
- HYPONIV
- Status last verified
- Dec 2025
- First submitted
- 12 Dec 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Murray I, Paterson E, Thain G, Currie GP. Outcomes following non-invasive ventilation for hypercapnic exacerbations of chronic obstructive pulmonary disease. Thorax. 2011 Sep;66(9):825-6. doi: 10.1136/thx.2010.152264. Epub 2010 Dec 9. No abstract available.
PubMed 21148571
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Nocturnal Hypoventilation in Predicting the Long-Term Ventilatory Response in Hypercapnic COPD Patients Treated With Non-Invasive Ventilation: A Prospective Observational Study With Clinical, Functional, and Radiological Assessment
- ClinicalTrials.gov ID
- NCT07414108
- Acronym / sponsor ID
- HYPONIV / HYPONIV
- Conditions
- COPD, COPD (Chronic Obstructive Pulmonary Disease), Hypercapnia, Hypercapnic Respiratory Failure, COPD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 17 Feb 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.
The study is an observational, single-center, prospective cohort study aiming to evaluate respiratory mechanics data, as well as clinical and functional parameters commonly used in clinical practice in patients with COPD and hypercapnic respiratory failure. The study population consists of patients with COPD and hypercapnia requiring NIV. The primary objective of the study is to evaluate the association between the reduction in partial pressure of carbon dioxide in arterial blood (PaCO₂) levels at 6 and 12 months after initiating non-invasive ventilation (NIV) and the presence of nocturnal hypoventilation detected at baseline in patients with COPD and chronic hypercapnia. Secondary objectives of this study are the evaluation of the following parameters measured at baseline and/or after 6 and 12 months of NIV treatment in patients with COPD and chronic hypercapnia:
- Magnitude of esophageal pressure swing during nocturnal monitoring.
- Diaphragm thickness and diaphragmatic thickening fraction assessed by thoracic ultrasound.
- Presence of overlap syndrome (COPD + OSA).
- Radiological classification of COPD subtypes to assess the association between radiological findings, functional profile, severity of nocturnal hypoventilation, and patterns of chronic hypercapnia.
- Respiratory functional parameters, including FEV₁, FVC, FEV₁/FVC ratio, carbon monoxide diffusion capacity (DLCO), and airway resistance (R5 and R20).
- Frequency of severe exacerbations and subsequent rehospitalizations during follow-up.
- Rate of compliance with respiratory treatment.
Detailed description
To date, the pathophysiological mechanisms underlying the development of persistent hypercapnia in patients with COPD are not completely understood. Likewise, reliable predictive markers capable of identifying both patients at risk of developing this condition and those who may derive the greatest benefit from long-term non-invasive ventilation (NIV) are still lacking. Early identification of a patient phenotype more responsive to this type of intervention could substantially reduce exacerbations, emergency department visits, hospitalizations, and associated healthcare costs, thereby improving the overall efficiency of the local healthcare system. The aim of this study is therefore to identify more accurate and earlier criteria to recognize patients with COPD and hypercapnic respiratory failure who may benefit from long-term non-invasive ventilatory support, through an integrated analysis of respiratory mechanics data and clinical and functional parameters commonly used in routine clinical practice.
The study population consists of patients with COPD and hypercapnic respiratory failure who require NIV and who are evaluated in the outpatient clinic and/or inpatient unit of the Respiratory and Critical Care Unit of the IRCCS AOU of Bologna. For these patients clinical, functional, and respiratory mechanics data will be collected. Data will be collected at the baseline visit-corresponding to the first visit at the OSAS Ventilated outpatient clinic or the first day of hospitalization in the Pneumology and Respiratory Intensive Care Unit-and during follow-up visits, scheduled according to routine clinical practice at 6 and 12 months after initiation of NIV treatment.
The total duration of the study will be 30 months, including 12 months for patient enrollment, 12 months of follow-up, and 6 months for data analysis.
A total of 25 patients will be included.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
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 patients with COPD and hypercapnic respiratory failure who require NIV and who are evaluated in the outpatient clinic and/or inpatient unit of the Respiratory and Critical Care Unit of the IRCCS AOU of Bologna.
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Patients with COPD and hypercapnia, defined as PaCO₂ > 50 mmHg either chronically or 4 weeks after an acute exacerbation requiring invasive or non-invasive mechanical ventilation
- Provision of informed consent
Key exclusion criteria (10 listed)
- Progressive neurodegenerative diseases
- Diaphragmatic disorders
- Severe hemodynamic instability (>1 vasoactive agent for at least 24 hours)
- Acute coronary syndrome (unstable angina / myocardial infarction)
- Severe arrhythmias
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
The association between the reduction in PaCO₂ levels and the presence of nocturnal hypoventilation
Time frame: PaCO₂ (mmHg), measured by ABG - baseline, 3, 6, and 12 months TcCO₂ (mmHg), measured by transcutaneous monitoring - baseline
The primary outcome is measured through arterial blood gas analysis (ABG) to determine PaCO₂ levels, and through transcutaneous monitoring of oxygen saturation and carbon dioxide (SpO₂ and TcCO₂) to assess the presence of nocturnal hypoventilation. Nocturnal hypoventilation is defined as an increase in PaCO₂ during sleep (TcCO₂ >10 mmHg above daytime PaCO₂ with TcCO₂ >50 mmHg for at least 10 minutes, or TcCO₂ >55 mmHg for ≥25% of total sleep time).
11 secondary outcomes
Magnitude of esophageal pressure swing during nocturnal monitoring
Time frame: Baseline
Diaphragm thickness and diaphragmatic thickening fraction
Time frame: Baseline
Diaphragmatic thickening fraction
Time frame: Baseline
Presence of overlap syndrome (COPD + OSA)
Time frame: Baseline
Radiological classification of COPD subtypes
Time frame: Baseline
Respiratory functional parameters
Time frame: Baseline, 6 and 12 months
Respiratory functional parameters
Time frame: Baseline, 6 and 12 months
Respiratory functional parameters
Time frame: Baseline, 6 and 12 months
Respiratory functional parameters
Time frame: Baseline, 6 and 12 months
Frequency of severe exacerbations
Time frame: baseline, 6 and 12 months
Compliance with respiratory treatment
Time frame: baseline, 6 and 12 months
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 17 Feb 2026.
- Background: PubMed 21148571Murray I, Paterson E, Thain G, Currie GP. Outcomes following non-invasive ventilation for hypercapnic exacerbations of chronic obstructive pulmonary disease. Thorax. 2011 Sep;66(9):825-6. doi: 10.1136/thx.2010.152264. Epub 2010 Dec 9. No abstract available.
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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.
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 and COPD (Chronic Obstructive Pulmonary Disease), run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 3 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 17 Feb 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 Italy. 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?
Contact Lara Pisani, PhD (0512143253, lara.pisani@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The association between the reduction in PaCO₂ levels and the presence of nocturnal hypoventilation (time frame: PaCO₂ (mmHg), measured by ABG - baseline, 3, 6, and 12 months TcCO₂ (mmHg), measured by transcutaneous monitoring - baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07414108, which also lists 1 linked publication.
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 17 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.