NCT01854398

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

May 10, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 15, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

January 26, 2017

Status Verified

January 1, 2017

Enrollment Period

3.1 years

First QC Date

May 10, 2013

Last Update Submit

January 24, 2017

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive sleep apneaContinuous positive airway pressurediastolic function

Outcome Measures

Primary Outcomes (1)

  • The differences of supine bicycle exercise echocardiographic parameters and PWV before and after CPAP therapy, and between CPAP group and sham CPAP group.

    The differences of supine bicycle exercise echocardiogrphic parameters (diastolic function grade, mitral inflow parameters, mitral tissue doppler parameters, E/E') and PWV before and after CPAP therapy, and between CPAP group and sham CPAP group.

    after 3 months intervention (CPAP)

Study Arms (2)

CPAP group

EXPERIMENTAL
Device: CPAP group

sham-CPAP group

SHAM COMPARATOR
Device: sham-CPAP group

Interventions

CPAP groupDEVICE

Enrolled patients are randomized to CPAP group or sham-CPAP group by 1:1 ratio. The patients in each group will undergo CPAP or sham-CPAP for 3 months.

CPAP group
sham-CPAP groupDEVICE

Enrolled patients are randomized to CPAP group or sham-CPAP group by 1:1 ratio. The patients in each group will undergo CPAP or sham-CPAP for 3 months. Sham CPAP consists of a CPAP machine that is modified to include a large hidden leak in the exhaust port of the mask to disperse the therapeutic pressure.

sham-CPAP group

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine

Seoul, Seoul, 120-752, South Korea

Location

Related Publications (1)

  • Shim CY, Kim D, Park S, Lee CJ, Cho HJ, Ha JW, Cho YJ, Hong GR. Effects of continuous positive airway pressure therapy on left ventricular diastolic function: a randomised, sham-controlled clinical trial. Eur Respir J. 2018 Jan 31;51(2):1701774. doi: 10.1183/13993003.01774-2017. Print 2018 Feb.

    PMID: 29386335DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2013

First Posted

May 15, 2013

Study Start

May 1, 2013

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

January 26, 2017

Record last verified: 2017-01

Locations

KR(1)