NCT02127177

Brief Summary

The increased risk of atherosclerotic morbidity and mortality in patients with obstructive sleep apnea (OSA) has been linked to hypertension, insulin resistance, dyslipidemia, and systemic inflammation. The relationship regarding obstructive sleep apnea (OSA) and lipidemia and systemic inflammation is far from conclusion for obesity as a strong confounding factor.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 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

January 1, 2010

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 30, 2014

Completed
Last Updated

April 30, 2014

Status Verified

April 1, 2014

Enrollment Period

3.9 years

First QC Date

April 24, 2014

Last Update Submit

April 28, 2014

Conditions

Obstructive Sleep ApneaCoronary Heart Disease

Keywords

obstructive sleep apneacoronary heart diseasecontinuous positive airway pressurelipid profileshigh-sensitivity C-reactive protein

Outcome Measures

Primary Outcomes (1)

  • lipid profiles

    plasma fasting lipid profiles were measured at baseline, 6months，and 12months.

    baseline, Change from baseline lipids at 6 months，Change from baseline lipids at 12 months

Secondary Outcomes (1)

  • High-sensitivity C-reactive protein

    baseline,Change from baseline high-sensitivity C-reactive protein at 6 months,Change from baseline high-sensitivity C-reactive protein at 12 months

Study Arms (2)

Cpap

EXPERIMENTAL
Device: Continuous Positive Airway Pressure Ventilator

No Cpap

NO INTERVENTION

Interventions

Continuous Positive Airway Pressure VentilatorDEVICE

CPAP group received fixed-level CPAP titration using an automated pressure setting device for one night. The optimal CPAP pressure for each patient in the CPAP group was set at the minimum pressure required to abolish snoring, obstructive respiratory events, and airflow limitation for 95% of the night, according to a previous validation by our study.

Also known as: Continuous Positive Airway Pressure(CPAP)
Cpap

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants diagnosed with a confirmation of CHD and moderate to severe

You may not qualify if:

  • A body mass index (BMI) ≥ 25 kg/m2
  • Established hypertension, diabetes mellitus, predominantly central sleep apnea, hypothyroidism
  • A history of smoking, chronic obstructive pulmonary disease, atopy, rhinitis, arthritis
  • Pharmacological treatment that could affect lipids and hs-CRP levels
  • Epworth Sleepiness Scale (ESS) ≥15
  • Diagnosed with malignant cancer with a life expectancy of less than 1 years
  • Severe psychiatric disease, sustained excessive alcohol use, New York Heart Association Class III-IV degree
  • Declined to participate or were unable to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

center of pulmonary vascular disease, Fuwai hospital

Beijing, 100037, China

Location

Related Publications (1)

  • Huang Z, Liu Z, Zhao Z, Zhao Q, Luo Q, Tang Y. Effects of Continuous Positive Airway Pressure on Lipidaemia and High-sensitivity C-reactive Protein Levels in Non-obese Patients with Coronary Artery Disease and Obstructive Sleep Apnoea. Heart Lung Circ. 2016 Jun;25(6):576-83. doi: 10.1016/j.hlc.2015.10.021. Epub 2016 Jan 4.

    PMID: 26804247DERIVED

MeSH Terms

Conditions

Sleep Apnea, ObstructiveCoronary Disease

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2014

First Posted

April 30, 2014

Study Start

January 1, 2010

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

April 30, 2014

Record last verified: 2014-04

Locations

CN(1)