Diaphragmatic Function and Respiratory Drive in OSA and COPD
NCT ID: NCT07003399
Last Updated: 2025-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
80 participants
OBSERVATIONAL
2025-01-01
2025-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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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.
Diaphragmatic Ultrasound and EMG Assessment
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.
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.
Diaphragmatic Ultrasound and EMG Assessment
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
Patients diagnosed with chronic obstructive pulmonary disease (COPD) based on GOLD guidelines, assessed for diaphragmatic morphofunction and respiratory drive.
Diaphragmatic Ultrasound and EMG Assessment
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.
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.
Diaphragmatic Ultrasound and EMG Assessment
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.
Interventions
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Diaphragmatic Ultrasound and EMG Assessment
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.
Eligibility Criteria
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Inclusion Criteria
2. For OSA Group: Diagnosed obstructive sleep apnea with AHI ≥ 5 events/hour based on overnight polysomnography.
3. For COPD Group: Diagnosed chronic obstructive pulmonary disease based on GOLD guidelines.
4. For Overlap Group: Diagnosed both OSA (AHI ≥ 5) and COPD.
5. For Control Group: Healthy volunteers with no known respiratory diseases or sleep disorders.
6. Ability and willingness to provide informed consent for participation in the study.
Exclusion Criteria
2. Severe hepatic or renal insufficiency.
3. Neuromuscular diseases affecting respiratory muscles.
4. Recent upper airway or thoracic surgery (within 3 months).
5. Pregnancy or breastfeeding.
6. Participants who cannot complete assessments due to cognitive impairment or poor cooperation.
18 Years
80 Years
ALL
Yes
Sponsors
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Nanjing Medical University
OTHER
Responsible Party
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Ning Ding
Principal Investigator
Locations
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The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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2021-SR-347
Identifier Type: -
Identifier Source: org_study_id
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