Diaphragmatic Function and Respiratory Drive in OSA and COPD
Recruiting · NCT07003399 · Observational (researchers observe without assigning treatment) · Lead sponsor: Nanjing Medical University
View the official record on ClinicalTrials.gov →Interventions studied
Diaphragmatic Ultrasound and EMG Assessment
What this trial is about
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.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where it is running
1 location listed.
- The First Affiliated Hospital of Nanjing Medical University - Nanjing, Jiangsu, China