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The Effect of Continuous Positive Airway Pressure on Diastolic Function in Patients With Obstructive Sleep Apnea

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Yonsei University

Status

Completed

Conditions

Obstructive Sleep Apnea

Treatments

Device: CPAP group
Device: sham-CPAP group

Study type

Interventional

Funder types

Other

Identifiers

NCT01854398
1-2013-0021

Details and patient eligibility

About

The association of obstructive sleep apnea (OSA) and cardiac diastolic dysfunction have been reported, and improvement of diastolic function after continuous positive airway pressure (CPAP) in OSA patients was observed. However, more detailed analysis of diastolic function by supine bicycle exercise echocardiography is lacking. The investigators hypothesized that 3 months of CPAP therapy in OSA patients will significantly improve diastolic functional parameters measured by exercise stress echocardiography. Patients with severe OSA (Apnea-hypopnea index > 30) will be included in this study, and randomized to CPAP versus sham-CPAP group by 1:1 ratio. Supine bicycle exercise echocardiography, pulse wave velocity, 24 hours ambulatory blood pressure (BP), central BP will be checked before and after CPAP therapy and parameters will be compared.

Enrollment

60 patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patietns≥20 and ≤75 years-old
  • Patients who diagnosed as obstructive sleep apnea and AHI>30 on polysomnography

Exclusion criteria

  • Age < 20 years-old
  • Left ventricular dysfunction (LVEF<50%) or structural heart disease on transthoracic echocardiography
  • Diabetes mellitus
  • Significant cardiac valvular disease (≥moderate)
  • Severe hypertension (>180/110mmHg)
  • Moderate or severe kidney disease (eGFR < 60 mL/min )
  • Clinically significant liver disease
  • History of coronary artery disease
  • malignancy or autoimmune disease
  • Acute/chronic infection status
  • Pregnant status
  • Patients taking anxiolytics or sedatives

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups

CPAP group
Experimental group
Treatment:
Device: CPAP group
sham-CPAP group
Sham Comparator group
Treatment:
Device: sham-CPAP group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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