Diaphragmatic Function and Respiratory Drive in OSA and COPD

NCT ID: NCT07003399

Last Updated: 2025-06-25

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-01

Study Completion Date

2025-08-31

Brief Summary

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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.

Detailed Description

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This is a single-center cross-sectional study designed to compare the diaphragmatic morphofunction and respiratory drive among four groups: OSA, COPD, overlap syndrome (patients with both OSA and COPD), and healthy controls. Participants will undergo overnight polysomnography (PSG), spirometry, impulse oscillometry, and diaphragm ultrasound combined with surface EMGdi measurements. The study will analyze group differences in diaphragmatic thickness, excursion, thickening fraction, and EMGdi parameters including EMGdi-rest, EMGdi-max, and EMGdi%max. The relationships between diaphragmatic indicators and respiratory parameters (FEV1, FVC, AHI, R5-R20, etc.) will also be assessed. This study aims to provide objective evidence for diaphragmatic dysfunction characterization in OSA and COPD, as well as to explore its diagnostic utility in overlap syndrome.

Conditions

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Obstructive Sleep Apnea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type 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.

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

Intervention Type 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

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

Diaphragmatic Ultrasound and EMG Assessment

Intervention Type 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.

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

Intervention Type 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.

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Patients aged between 18 and 80 years.
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

1. Severe cardiovascular diseases (e.g., unstable angina, heart failure NYHA III/IV).
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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Ning Ding

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ding Ning, doctor

Role: CONTACT

86-25-68136723

Facility Contacts

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Ding Ning, doctor

Role: primary

86-25-68136723

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.

Reference Type BACKGROUND
PMID: 35034195 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26312873 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27807016 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32836084 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26795460 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35861594 (View on PubMed)

Other Identifiers

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2021-SR-347

Identifier Type: -

Identifier Source: org_study_id

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