Upper Airway Morphology and Physiology During Graded Positive Pressure and Nasal High Flow: An MRI Study

NCT07886502 | Not Yet Recruiting

• 1 other identifier: AIR-MRI-132/2026
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD; Nasal high flow; Positive airway pressure; Magnetic resonance imaging; Upper airway volume; Upper airway morphology; Breathing physiology

Outcome Measures

Primary Outcomes (1)

• 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.

  At baseline and at each NHF and CPAP condition

Secondary Outcomes (1)

• Retropalatal upper airway cross-sectional area

  At baseline and at each NHF and CPAP condition

Other Outcomes (1)

• Respiratory physiological responses

  At baseline and at each NHF and CPAP condition

Study Arms (2)

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.

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.

Device: Nasal High Flow; Device: Continuous Positive Airway Pressure

Interventions

Nasal High Flow DEVICE

Nasal high flow applied at flow rates of 30 and 60 L/min during MRI and physiological assessment.

Healthy Volunteers; Patients with COPD

Continuous Positive Airway Pressure DEVICE

Continuous positive airway pressure applied at pressure levels of 4 and 12 cmH₂O during MRI and physiological assessment.

Healthy Volunteers; Patients with COPD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Written informed consent
• Age ≥18 years
• BMI ≤30 kg/m²

You may not qualify if:

• 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

Sponsors & Collaborators

• Klinikum Dortmund Wirbelsäulenchirurgie: lead
• Fisher & Paykel Healthcare: collaborator

Study Sites (1)

Klinikum Dortmund

Dortmund, 44145, Germany

Location

Related Publications (6)

• 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.

  PMID: 1928972 BACKGROUND

• Schwab 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.

  PMID: 8239180 BACKGROUND

• Kuna 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.

  PMID: 3059886 BACKGROUND

• Nilius 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.

  PMID: 41836030 BACKGROUND

• Nagata 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.

  PMID: 35771533 BACKGROUND

• Macrea 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.

  PMID: 32795139 BACKGROUND

Related Links

• Website of the Department of Pulmonology providing information on current and completed research projects.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Georg Nilius

  Klinikum Dortmund

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maik F Schröder

CONTACT

0049 (0)152 023 985 43; maik.schroeder@klinikumdo.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of Pulmonology

Study Record Dates

• First Submitted: October 1, 2026
• First Posted: October 21, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)