An observational study in Chronic Obstructive Pulmonary Disease (COPD), sponsored by Klinikum Dortmund Wirbelsäulenchirurgie. Not yet recruiting at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Klinikum Dortmund Wirbelsäulenchirurgie · Observational
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.
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.
4,252 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.
This study's planned enrollment of 20 is below the median of 183 across 1,099 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →This is the only study on the registry with Klinikum Dortmund Wirbelsäulenchirurgie as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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.
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Exclusion Criteria:
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.
Device: Nasal High Flow · Device: Continuous Positive Airway Pressure
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.
Device: Nasal High Flow · Device: Continuous Positive Airway Pressure
Nasal high flow applied at flow rates of 30 and 60 L/min during MRI and physiological assessment.
Continuous positive airway pressure applied at pressure levels of 4 and 12 cmH₂O during MRI and physiological assessment.
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.
Time frame: At baseline and at each NHF and CPAP condition
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.
Time frame: At baseline and at each NHF and CPAP condition
Respiratory physiological responses
Assessment of respiratory physiological responses under the respective study conditions.
Time frame: At baseline and at each NHF and CPAP condition
Plan to share: No — Aggregated or non-identifiable study data may be made available upon reasonable request, subject to applicable ethical, legal, and data protection requirements.
Start is estimated for Oct 2026; primary completion for Dec 2027, 14 months later.
Of 330 non-industry observational studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 86. This study's planned 14 months is below that.
Counting every sponsor, half of 429 studies reached it within 28 months; a quarter within 16 and three quarters within 62.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive →