Diaphragmatic Function and Respiratory Drive in OSA and COPD

NCT07003399 | Recruiting DMC

• 1 other identifier: 2021-SR-347
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This cross-sectional observational study aims to assess the diaphragmatic morphofunction and respiratory drive characteristics among patients with obstructive sleep apnea (OSA), chronic obstructive pulmonary disease (COPD), overlap syndrome (OS), and healthy controls. Using ultrasound imaging and surface diaphragm electromyography (EMGdi), the study will explore group differences in diaphragmatic morphology, function, and respiratory drive indicators, and evaluate their clinical significance in disease differentiation and severity assessment.

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep Apnea; Chronic Obstructive Pulmonary Disease; Overlap Syndrome

Outcome Measures

Primary Outcomes (3)

• Diaphragmatic electromyography (EMGdi-rest) at baseline

  To assess resting diaphragmatic electromyographic activity (µV) across OSA, COPD, Overlap, and control groups using surface and esophageal EMG.

  Baseline (at enrollment)

• Diaphragmatic EMG during maximal inspiration (EMGdi-max)

  To assess maximal inspiratory diaphragmatic EMG activity (µV) using voluntary effort tests with surface and esophageal EMG.

  Baseline (at enrollment)

• Relative inspiratory EMG effort (EMGdi%max)

  To calculate the ratio of EMGdi-rest to EMGdi-max as a percentage, reflecting the relative inspiratory effort.

  Baseline (at enrollment)

Secondary Outcomes (11)

• Diaphragmatic excursion measured by ultrasound during deep breathing

  Baseline (at enrollment)

• Respiratory impedance parameter R5

  Baseline (at enrollment)

• Respiratory resistance at 20 Hz (R20)

  Baseline (at enrollment)

• Difference in resistance (R5-R20)

  Baseline (at enrollment)

• Forced expiratory volume in 1 second (FEV1)

  Baseline (at enrollment)

Study Arms (4)

Normal Group

Healthy subjects with no known respiratory diseases or sleep disorders, serving as the control group for baseline comparison of diaphragmatic function and respiratory drive.

Other: Diaphragmatic Ultrasound and EMG Assessment

OSA Group

Patients diagnosed with obstructive sleep apnea (OSA) based on polysomnography criteria (AHI ≥ 5 events/hour), evaluated for diaphragmatic function and respiratory drive using ultrasound and EMG.

Other: Diaphragmatic Ultrasound and EMG Assessment

COPD Group

Patients diagnosed with chronic obstructive pulmonary disease (COPD) based on GOLD guidelines, assessed for diaphragmatic morphofunction and respiratory drive.

Other: Diaphragmatic Ultrasound and EMG Assessment

Overlap Group

Patients with overlap syndrome (coexisting OSA and COPD), evaluated for diaphragmatic function and respiratory drive using ultrasound and EMG to explore combined disease impact.

Other: Diaphragmatic Ultrasound and EMG Assessment

Interventions

Diaphragmatic Ultrasound and EMG Assessment OTHER

Non-invasive assessment of diaphragmatic morphofunction and respiratory drive using ultrasound imaging and diaphragm electromyography (EMG). This evaluation will be performed once per participant without any therapeutic intervention.

COPD Group; Normal Group; OSA Group; Overlap Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with obstructive sleep apnea, chronic obstructive pulmonary disease, overlap syndrome (OSA and COPD), and healthy volunteers from a single center. Subjects will be evaluated for diaphragmatic morphofunction and respiratory drive using ultrasound and EMG.

You may qualify if:

• Patients aged between 18 and 80 years.
• For OSA Group: Diagnosed obstructive sleep apnea with AHI ≥ 5 events/hour based on overnight polysomnography.
• For COPD Group: Diagnosed chronic obstructive pulmonary disease based on GOLD guidelines.
• For Overlap Group: Diagnosed both OSA (AHI ≥ 5) and COPD.
• For Control Group: Healthy volunteers with no known respiratory diseases or sleep disorders.
• Ability and willingness to provide informed consent for participation in the study.

You may not qualify if:

• Severe cardiovascular diseases (e.g., unstable angina, heart failure NYHA III/IV).
• Severe hepatic or renal insufficiency.
• Neuromuscular diseases affecting respiratory muscles.
• Recent upper airway or thoracic surgery (within 3 months).
• Pregnancy or breastfeeding.
• Participants who cannot complete assessments due to cognitive impairment or poor cooperation.

Sponsors & Collaborators

• Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

Related Publications (6)

• Domnik NJ, Phillips DB, James MD, Ayoo GA, Taylor SM, Scheeren RE, Di Luch AT, Milne KM, Vincent SG, Elbehairy AF, Crinion SJ, Driver HS, Neder JA, O'Donnell DE. Compensatory responses to increased mechanical abnormalities in COPD during sleep. Eur J Appl Physiol. 2022 Mar;122(3):663-676. doi: 10.1007/s00421-021-04869-0. Epub 2022 Jan 16.

  PMID: 35034195 BACKGROUND

• Jolley C, Luo Y, Steier J, Sylvester K, Man W, Rafferty G, Polkey M, Moxham J. Neural respiratory drive and symptoms that limit exercise in chronic obstructive pulmonary disease. Lancet. 2015 Feb 26;385 Suppl 1:S51. doi: 10.1016/S0140-6736(15)60366-X.

  PMID: 26312873 BACKGROUND

• He BT, Lu G, Xiao SC, Chen R, Steier J, Moxham J, Polkey MI, Luo YM. Coexistence of OSA may compensate for sleep related reduction in neural respiratory drive in patients with COPD. Thorax. 2017 Mar;72(3):256-262. doi: 10.1136/thoraxjnl-2016-208467. Epub 2016 Nov 2.

  PMID: 27807016 BACKGROUND

• Zhang N, Luo Y, Yang L, Liu Z, Qiu Z, Huang Q, Zhang Y. Novel method for evaluating the upper airway resistance using the ratio of neural respiratory drive to flow in OSA. Sleep Med. 2020 Sep;73:162-169. doi: 10.1016/j.sleep.2020.05.006. Epub 2020 May 15.

  PMID: 32836084 BACKGROUND

• Ramsook AH, Koo R, Molgat-Seon Y, Dominelli PB, Syed N, Ryerson CJ, Sheel AW, Guenette JA. Diaphragm Recruitment Increases during a Bout of Targeted Inspiratory Muscle Training. Med Sci Sports Exerc. 2016 Jun;48(6):1179-86. doi: 10.1249/MSS.0000000000000881.

  PMID: 26795460 BACKGROUND

• James MD, Phillips DB, Vincent SG, Abdallah SJ, Donovan AA, de-Torres JP, Neder JA, Smith BM, Jensen D, O'Donnell DE; Canadian Respiratory Research Network. Exertional dyspnoea in patients with mild-to-severe chronic obstructive pulmonary disease: neuromechanical mechanisms. J Physiol. 2022 Sep;600(18):4227-4245. doi: 10.1113/JP283252. Epub 2022 Aug 5.

  PMID: 35861594 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ding Ning, doctor

CONTACT

86-25-68136723; dr.ningding@live.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: June 4, 2025
• Study Start: January 1, 2025
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)