Chronic Obstructive Pulmonary Disease (COPD)AIR-MRINCT07886502
Upper Airway Morphology and Physiology During Graded Positive Pressure and Nasal High Flow: An MRI Study
An observational study of Chronic Obstructive Pulmonary Disease (COPD), run by Klinikum Dortmund Wirbelsäulenchirurgie at 1 site in Germany.
Trial summary
This study investigates the effects of graded nasal high flow (NHF) and continuous positive airway pressure (CPAP) on upper airway morphology and respiratory physiology in healthy volunteers and patients with COPD. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Nasal High Flow and Continuous Positive Airway Pressure
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2026to 1 Jul 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study includes healthy adult volunteers and patients with COPD. All participants are adults aged ≥18 years with a BMI ≤30 kg/m² and undergo MRI and respiratory physiological assessments under graded nasal high flow and continuous positive airway pressure.
Who may be able to join
- Written informed consent
- Age ≥18 years
- BMI ≤30 kg/m²
Who cannot join
- Inability or refusal to provide informed consent
- Contraindications to MRI (e.g., claustrophobia or ferromagnetic implants)
- Contraindications to mask-based positive airway pressure or nasal high flow
- Pregnancy
- Physical or mental conditions limiting study participation or compliance, as judged by the investigator
- Alcohol, drug, medication, or other substance abuse
- Any other objective reason preventing study participation, as determined by the investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
Klinikum Dortmund
Dortmund, 44145
Maik F Schröder, 015202398543, maik.schroeder@klinikumdo.de
Georg Nilius, MD
About this study
Official title: Effects of Graded Positive Airway Pressure and Nasal High Flow Interfaces on Upper Airway Morphology and Breathing Physiology in Healthy Volunteers and COPD Patients: A Controlled MRI Study
This study investigates the effects of graded nasal high flow (NHF) and continuous positive airway pressure (CPAP) on upper airway morphology and respiratory physiology in healthy volunteers and patients with COPD. Participants undergo baseline MRI and physiological assessment followed by NHF at 30 and 60 L/min and CPAP at 4 and 12 cmH₂O. The primary aim is to determine whether graded NHF and CPAP induce dose-dependent changes in upper airway morphology, including upper airway volume and cross-sectional area, during MRI scans.
Read the detailed description
Background: Nasal and oronasal masks are the gold standard when applying non-invasive ventilation in chronic hypercapnic respiratory failure, providing effective pressure support and CO2 clearance. Nasal high flow (NHF) offers a less invasive alternative with modest positive pressure, but its effect on upper airway anatomy remain largely unknown.
The positive airway pressure can influence airway calibre, dynamics, and upper airway closure, but the effects of nasal high flow (NHF) on upper airway morphology have not been directly investigated by MRI.
Aims: This study investigates the effects of NHF at different flow rates compared to continuous positive airway pressure (CPAP) on upper airway morphology and respiratory physiology in healthy volunteers and patients with COPD. The primary aim is to determine whether graded NHF and CPAP induce measurable, dose-dependent changes in upper airway volume and cross-sectional area assessed by MRI.
Methods: After baseline MRI and physiological assessment, each participant will undergo repeated measurements under two respiratory support modalities: NHF at 30 and 60 L/min and CPAP at 4 and 12 cmH₂O. The two modalities will be applied in randomized order, while both graded settings within each modality will be assessed. MRI will be used to assess changes in upper airway morphology. Respiratory physiology will be assessed under each condition by measuring tidal volume, respiratory rate, minute ventilation, inspiratory and expiratory times, transcutaneous CO₂, inspiratory effort, and work of breathing.
- Being tested
- Nasal High Flow, Continuous Positive Airway Pressure
- Keywords
- COPD, Nasal high flow, Positive airway pressure, Magnetic resonance imaging, Upper airway volume, Upper airway morphology, Breathing physiology
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal High FlowDevice
Nasal high flow applied at flow rates of 30 and 60 L/min during MRI and physiological assessment.
Continuous Positive Airway PressureDevice
Continuous positive airway pressure applied at pressure levels of 4 and 12 cmH₂O during MRI and physiological assessment.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Healthy adult volunteers undergo baseline MRI and physiological assessment followed by repeated measurements under graded nasal high flow (NHF) at 30 and 60 L/min and continuous positive airway pressure (CPAP) at 4 and 12 cmH₂O. NHF and CPAP are applied in randomized order. Receives: Device: Nasal High Flow; Device: Continuous Positive Airway Pressure | |
| Patients with COPD | Patients with COPD undergo the same study procedures as the healthy volunteer cohort, including baseline MRI and physiological assessment followed by repeated measurements under graded NHF at 30 and 60 L/min and CPAP at 4 and 12 cmH₂O. NHF and CPAP are applied in randomized order. Receives: Device: Nasal High Flow; Device: Continuous Positive Airway Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retropalatal posterior airway space volume
Change in total retropalatal posterior airway space volume (cm³) from baseline under graded NHF and CPAP conditions, assessed by MRI.
Measured: At baseline and at each NHF and CPAP condition
Secondary outcomes (1)
Retropalatal upper airway cross-sectional area
Change in retropalatal upper airway cross-sectional area (mm²) from baseline under graded NHF and CPAP conditions, assessed by MRI.
Measured: At baseline and at each NHF and CPAP condition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Klinikum Dortmund Wirbelsäulenchirurgie
- Sponsor type
- University, hospital or other
- Collaborators
- Fisher & Paykel Healthcare
- Responsible party
- Principal investigator, Prof. Georg Nilius, MD, Klinikum Dortmund Wirbelsäulenchirurgie
- Investigators
- Georg Nilius, Principal investigator, Klinikum Dortmund
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07886502
- Sponsor's protocol ID
- AIR-MRI-132/2026
- Acronym
- AIR-MRI
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Aggregated or non-identifiable study data may be made available upon reasonable request, subject to applicable ethical, legal, and data protection requirements.
Publications
Ryan CF, Lowe AA, Li D, Fleetham JA. Magnetic resonance imaging of the upper airway in obstructive sleep apnea before and after chronic nasal continuous positive airway pressure therapy. Am Rev Respir Dis. 1991 Oct;144(4):939-44. doi: 10.1164/ajrccm/144.4.939.
PubMed 1928972Schwab RJ, Gefter WB, Hoffman EA, Gupta KB, Pack AI. Dynamic upper airway imaging during awake respiration in normal subjects and patients with sleep disordered breathing. Am Rev Respir Dis. 1993 Nov;148(5):1385-400. doi: 10.1164/ajrccm/148.5.1385.
PubMed 8239180Kuna ST, Bedi DG, Ryckman C. Effect of nasal airway positive pressure on upper airway size and configuration. Am Rev Respir Dis. 1988 Oct;138(4):969-75. doi: 10.1164/ajrccm/138.4.969.
PubMed 3059886Nilius G, Domanski U, Khalaf M, Schroeder M, Tatkov S. Enhancing Respiratory Support in COPD Patients with Nasal High Flow Using an Asymmetrical Cannula Interface: A Randomized Cross-Over Study. Int J Chron Obstruct Pulmon Dis. 2026 Mar 10;21:528199. doi: 10.2147/COPD.S528199. eCollection 2026.
PubMed 41836030Nagata K, Horie T, Chohnabayashi N, Jinta T, Tsugitomi R, Shiraki A, Tokioka F, Kadowaki T, Watanabe A, Fukui M, Kitajima T, Sato S, Tsuda T, Kishimoto N, Kita H, Mori Y, Nakayama M, Takahashi K, Tsuboi T, Yoshida M, Hataji O, Fuke S, Kagajo M, Nishine H, Kobayashi H, Nakamura H, Okuda M, Tachibana S, Takata S, Osoreda H, Minami K, Nishimura T, Ishida T, Terada J, Takeuchi N, Kohashi Y, Inoue H, Nakagawa Y, Kikuchi T, Tomii K. Home High-Flow Nasal Cannula Oxygen Therapy for Stable Hypercapnic COPD: A Randomized Clinical Trial. Am J Respir Crit Care Med. 2022 Dec 1;206(11):1326-1335. doi: 10.1164/rccm.202201-0199OC.
PubMed 35771533Macrea M, Oczkowski S, Rochwerg B, Branson RD, Celli B, Coleman JM 3rd, Hess DR, Knight SL, Ohar JA, Orr JE, Piper AJ, Punjabi NM, Rahangdale S, Wijkstra PJ, Yim-Yeh S, Drummond MB, Owens RL. Long-Term Noninvasive Ventilation in Chronic Stable Hypercapnic Chronic Obstructive Pulmonary Disease. An Official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2020 Aug 15;202(4):e74-e87. doi: 10.1164/rccm.202006-2382ST.
PubMed 32795139
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Graded Positive Airway Pressure and Nasal High Flow Interfaces on Upper Airway Morphology and Breathing Physiology in Healthy Volunteers and COPD Patients: A Controlled MRI Study
- ClinicalTrials.gov ID
- NCT07886502
- Acronym / sponsor ID
- AIR-MRI / AIR-MRI-132/2026
- Keywords
- COPD, Nasal high flow, Positive airway pressure, Magnetic resonance imaging, Upper airway volume, Upper airway morphology, Breathing physiology
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Klinikum Dortmund WirbelsäulenchirurgieUniversity, hospital or other
- Collaborators
- Fisher & Paykel Healthcare
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 21 Oct 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.
This study investigates the effects of graded nasal high flow (NHF) and continuous positive airway pressure (CPAP) on upper airway morphology and respiratory physiology in healthy volunteers and patients with COPD. Participants undergo baseline MRI and physiological assessment followed by NHF at 30 and 60 L/min and CPAP at 4 and 12 cmH₂O. The primary aim is to determine whether graded NHF and CPAP induce dose-dependent changes in upper airway morphology, including upper airway volume and cross-sectional area, during MRI scans.
Detailed description
Background: Nasal and oronasal masks are the gold standard when applying non-invasive ventilation in chronic hypercapnic respiratory failure, providing effective pressure support and CO2 clearance. Nasal high flow (NHF) offers a less invasive alternative with modest positive pressure, but its effect on upper airway anatomy remain largely unknown.
The positive airway pressure can influence airway calibre, dynamics, and upper airway closure, but the effects of nasal high flow (NHF) on upper airway morphology have not been directly investigated by MRI.
Aims: This study investigates the effects of NHF at different flow rates compared to continuous positive airway pressure (CPAP) on upper airway morphology and respiratory physiology in healthy volunteers and patients with COPD. The primary aim is to determine whether graded NHF and CPAP induce measurable, dose-dependent changes in upper airway volume and cross-sectional area assessed by MRI.
Methods: After baseline MRI and physiological assessment, each participant will undergo repeated measurements under two respiratory support modalities: NHF at 30 and 60 L/min and CPAP at 4 and 12 cmH₂O. The two modalities will be applied in randomized order, while both graded settings within each modality will be assessed. MRI will be used to assess changes in upper airway morphology. Respiratory physiology will be assessed under each condition by measuring tidal volume, respiratory rate, minute ventilation, inspiratory and expiratory times, transcutaneous CO₂, inspiratory effort, and work of breathing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | Device: Nasal High Flow, Device: Continuous Positive Airway PressureHealthy adult volunteers undergo baseline MRI and physiological assessment followed by repeated measurements under graded nasal high flow (NHF) at 30 and 60 L/min and continuous positive airway pressure (CPAP) at 4 and 12 cmH₂O. NHF and CPAP are applied in randomized order. |
| Patients with COPD | – | Device: Nasal High Flow, Device: Continuous Positive Airway PressurePatients with COPD undergo the same study procedures as the healthy volunteer cohort, including baseline MRI and physiological assessment followed by repeated measurements under graded NHF at 30 and 60 L/min and CPAP at 4 and 12 cmH₂O. NHF and CPAP are applied in randomized order. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study includes healthy adult volunteers and patients with COPD. All participants are adults aged ≥18 years with a BMI ≤30 kg/m² and undergo MRI and respiratory physiological assessments under graded nasal high flow and continuous positive airway pressure.
Key inclusion criteria (3 listed)
- Written informed consent
- Age ≥18 years
- BMI ≤30 kg/m²
Key exclusion criteria (7 listed)
- Inability or refusal to provide informed consent
- Contraindications to MRI (e.g., claustrophobia or ferromagnetic implants)
- Contraindications to mask-based positive airway pressure or nasal high flow
- Pregnancy
- Physical or mental conditions limiting study participation or compliance, as judged by the investigator
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 |
|---|---|---|
| Nasal High FlowNasal high flow applied at flow rates of 30 and 60 L/min during MRI and physiological assessment. | Device | Healthy Volunteers, Patients with COPD |
| Continuous Positive Airway PressureContinuous positive airway pressure applied at pressure levels of 4 and 12 cmH₂O during MRI and physiological assessment. | Device | Healthy Volunteers, Patients with COPD |
Primary outcome
Retropalatal posterior airway space volume
Time frame: At baseline and at each NHF and CPAP condition
Change in total retropalatal posterior airway space volume (cm³) from baseline under graded NHF and CPAP conditions, assessed by MRI.
1 secondary outcome
Retropalatal upper airway cross-sectional area
Time frame: At baseline and at each NHF and CPAP condition
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 21 Oct 2026.
- Background: PubMed 1928972Ryan CF, Lowe AA, Li D, Fleetham JA. Magnetic resonance imaging of the upper airway in obstructive sleep apnea before and after chronic nasal continuous positive airway pressure therapy. Am Rev Respir Dis. 1991 Oct;144(4):939-44. doi: 10.1164/ajrccm/144.4.939.
- Background: PubMed 8239180Schwab RJ, Gefter WB, Hoffman EA, Gupta KB, Pack AI. Dynamic upper airway imaging during awake respiration in normal subjects and patients with sleep disordered breathing. Am Rev Respir Dis. 1993 Nov;148(5):1385-400. doi: 10.1164/ajrccm/148.5.1385.
- Background: PubMed 3059886Kuna ST, Bedi DG, Ryckman C. Effect of nasal airway positive pressure on upper airway size and configuration. Am Rev Respir Dis. 1988 Oct;138(4):969-75. doi: 10.1164/ajrccm/138.4.969.
- Background: PubMed 41836030Nilius G, Domanski U, Khalaf M, Schroeder M, Tatkov S. Enhancing Respiratory Support in COPD Patients with Nasal High Flow Using an Asymmetrical Cannula Interface: A Randomized Cross-Over Study. Int J Chron Obstruct Pulmon Dis. 2026 Mar 10;21:528199. doi: 10.2147/COPD.S528199. eCollection 2026.
- Background: PubMed 35771533Nagata K, Horie T, Chohnabayashi N, Jinta T, Tsugitomi R, Shiraki A, Tokioka F, Kadowaki T, Watanabe A, Fukui M, Kitajima T, Sato S, Tsuda T, Kishimoto N, Kita H, Mori Y, Nakayama M, Takahashi K, Tsuboi T, Yoshida M, Hataji O, Fuke S, Kagajo M, Nishine H, Kobayashi H, Nakamura H, Okuda M, Tachibana S, Takata S, Osoreda H, Minami K, Nishimura T, Ishida T, Terada J, Takeuchi N, Kohashi Y, Inoue H, Nakagawa Y, Kikuchi T, Tomii K. Home High-Flow Nasal Cannula Oxygen Therapy for Stable Hypercapnic COPD: A Randomized Clinical Trial. Am J Respir Crit Care Med. 2022 Dec 1;206(11):1326-1335. doi: 10.1164/rccm.202201-0199OC.
- Background: PubMed 32795139Macrea M, Oczkowski S, Rochwerg B, Branson RD, Celli B, Coleman JM 3rd, Hess DR, Knight SL, Ohar JA, Orr JE, Piper AJ, Punjabi NM, Rahangdale S, Wijkstra PJ, Yim-Yeh S, Drummond MB, Owens RL. Long-Term Noninvasive Ventilation in Chronic Stable Hypercapnic Chronic Obstructive Pulmonary Disease. An Official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2020 Aug 15;202(4):e74-e87. doi: 10.1164/rccm.202006-2382ST.
- Website of the Department of Pulmonology providing information on current and completed research projects.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Aggregated or non-identifiable study data may be made available upon reasonable request, subject to applicable ethical, legal, and data protection requirements.
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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.
Georg Nilius principal investigator
Klinikum Dortmund
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 Obstructive Pulmonary Disease (COPD), run by Klinikum Dortmund Wirbelsäulenchirurgie at 1 site in Germany.
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 7 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: opening soon, as of the sponsor's last update on 21 Oct 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 Germany. 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 Maik F Schröder (0049 (0)152 023 985 43, maik.schroeder@klinikumdo.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retropalatal posterior airway space volume (time frame: At baseline and at each NHF and CPAP condition). 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 NCT07886502, which also lists 6 linked publications.
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 21 Oct 2026.