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
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
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- 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.
- 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
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- 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