Diaphragmatic Function and Respiratory Drive in OSA and COPD
ConditionObstructive Sleep Apnea
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorNanjing Medical University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial 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.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Diaphragmatic Ultrasound and EMG Assessment
Other interventionNon-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.
Treatment groups
80 Participants
are divided into 4 treatment groupsGroup A: Normal Group1 intervention
Group B: OSA Group1 intervention
Group C: COPD Group1 intervention
Group D: Overlap Group1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (at enrollment)2
Diaphragmatic EMG during maximal inspiration (EMGdi-max)
To assess maximal inspiratory diaphragmatic EMG activity (µV) using voluntary effort tests with surface and esophageal EMG.
Time frame
Baseline (at enrollment)3
Relative inspiratory EMG effort (EMGdi%max)
To calculate the ratio of EMGdi-rest to EMGdi-max as a percentage, reflecting the relative inspiratory effort.
Time frame
Baseline (at enrollment)Secondary outcomes
1
Diaphragmatic excursion measured by ultrasound during deep breathing
To evaluate diaphragmatic mobility (cm) during deep breathing using standardized ultrasound protocols.
Time frame
Baseline (at enrollment)2
Respiratory impedance parameter R5
To compare small airway resistance (kPa·s·L-¹) between groups using impulse oscillometry.
Time frame
Baseline (at enrollment)3
Respiratory resistance at 20 Hz (R20)
To compare central airway resistance (kPa·s·L-¹) using impulse oscillometry.
Time frame
Baseline (at enrollment)4
Difference in resistance (R5-R20)
To evaluate small airway dysfunction by calculating the difference between R5 and R20 (kPa·s·L-¹) .
Time frame
Baseline (at enrollment)Sponsors and contacts
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Source ClinicalTrials.gov