RecruitingNot Applicable

Diaphragmatic Function and Respiratory Drive in OSA and COPD

China80 participantsStarted 2025-01-01

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Diaphragmatic electromyography (EMGdi-rest) at baseline

Timeframe: Baseline (at enrollment)

Diaphragmatic EMG during maximal inspiration (EMGdi-max)

Timeframe: Baseline (at enrollment)

Relative inspiratory EMG effort (EMGdi%max)

Timeframe: Baseline (at enrollment)

Trial details

NCT IDNCT07003399

SponsorNanjing Medical University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-08-31

Contact for this trial

Ding Ning, doctor

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

View on ClinicalTrials.gov More Obstructive Sleep Apnea trials

Plain-language summary

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.