The Endothelium Dysfunction in Patients of Obstructive Sleep Apnea Syndrome

NCT01699126 | Completed Phase 4 DMC

• 1 other identifier: 98-2167B
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

study Hypothesis: We hypothesize that CPAP could effectively improve the endothelial dysfunction by anti-inflammatory effect in patients of OSA,and compare to the effect of statin.

Conditions

Sleep Apnea, Obstructive

Keywords

Obstructive Sleep Apnea; CPAP; Endothelium dysfunction; Hypertension

Outcome Measures

Primary Outcomes (1)

• Flow-Mediated dilatation test(FMD)

  FMD is the most sensitive physical marker of endothelial function, we measure the FMD changes after treatment

  6 months

Secondary Outcomes (1)

• Blood pressure

  6 months

Other Outcomes (2)

• Hs-CRP

  6 months

• Inflammatory markers

  6 months

Study Arms (4)

CPAP, Hypertension

EXPERIMENTAL

evaluate the effect on FMD, blood pressure and inflammation after CPAP on OSA

Device: CPAP

CPAP and statin, Hypertension

ACTIVE COMPARATOR

evaluate the effect on FMD, blood pressure and inflammation after CPAP plus statin on OSA patients

Device: CPAP; Drug: Statin

OSA, statin, Hypertension

ACTIVE COMPARATOR

evaluate the effect on FMD, blood pressure and inflammation after statin treatment on OSA

Drug: Statin

Placebo

NO INTERVENTION

We will also measure the FMD, blood pressure and inflammation on patients with only life style modification as in all other patients

Interventions

CPAP DEVICE

Continuous Positive Airway Pressure is the routine treatment of OSA, patients will be randomly assigned into CPAP treatment group

CPAP and statin, Hypertension; CPAP, Hypertension

Statin DRUG

Statin is an lipid lowering medication with anti-inflammatory effect.

Also known as: rosuvastatin

CPAP and statin, Hypertension; OSA, statin, Hypertension

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 1.OSA with AHI\>30 2.Male patients with hypertension 3.LDL over 130 mg/dL without any lipid-lowering drug therapy in recent 6 months 4.Signed inform consent and cooperative

You may not qualify if:

• \- 1.Non-cooperative 2.Can't sign inform consent. 3.Had proven major cardiovascular complication such as AMI, CVA. 4.Major chronic disorders and inflammatory disorders: such as DM, ESRD, COPD or rheumatoid arthritis. 5.Under anti-inflammatory medication: such as aspirin, NSAID, steroids, theophylline etc. 6.Acute of chronic infection 1 weeks between blood drawing period will be discarded 7.Study medication will be discontinued among subjects who develop myopathy (CK ≥10 times ULN and muscle aches or weakness) or a persistent elevation in ALT (≥3 times ULN on 2 consecutive tests).

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gang Memorial Hospital

Taoyuan District, 333, Taiwan

Location

Related Publications (11)

• Luthje L, Andreas S. Obstructive sleep apnea and coronary artery disease. Sleep Med Rev. 2008 Feb;12(1):19-31. doi: 10.1016/j.smrv.2007.08.002. Epub 2007 Nov 1.

  PMID: 17936040 RESULT

• Bradley TD, Floras JS. Obstructive sleep apnoea and its cardiovascular consequences. Lancet. 2009 Jan 3;373(9657):82-93. doi: 10.1016/S0140-6736(08)61622-0. Epub 2008 Dec 26.

  PMID: 19101028 RESULT

• Atkeson A, Yeh SY, Malhotra A, Jelic S. Endothelial function in obstructive sleep apnea. Prog Cardiovasc Dis. 2009 Mar-Apr;51(5):351-62. doi: 10.1016/j.pcad.2008.08.002.

  PMID: 19249441 RESULT

• Jelic S, Padeletti M, Kawut SM, Higgins C, Canfield SM, Onat D, Colombo PC, Basner RC, Factor P, LeJemtel TH. Inflammation, oxidative stress, and repair capacity of the vascular endothelium in obstructive sleep apnea. Circulation. 2008 Apr 29;117(17):2270-8. doi: 10.1161/CIRCULATIONAHA.107.741512. Epub 2008 Apr 14.

  PMID: 18413499 RESULT

• Gozal D, Kheirandish-Gozal L. Cardiovascular morbidity in obstructive sleep apnea: oxidative stress, inflammation, and much more. Am J Respir Crit Care Med. 2008 Feb 15;177(4):369-75. doi: 10.1164/rccm.200608-1190PP. Epub 2007 Nov 1.

  PMID: 17975198 RESULT

• Gilmartin GS, Tamisier R, Curley M, Weiss JW. Ventilatory, hemodynamic, sympathetic nervous system, and vascular reactivity changes after recurrent nocturnal sustained hypoxia in humans. Am J Physiol Heart Circ Physiol. 2008 Aug;295(2):H778-85. doi: 10.1152/ajpheart.00653.2007. Epub 2008 Jun 6.

  PMID: 18539753 RESULT

• Iturriaga R, Rey S, Del Rio R. Cardiovascular and ventilatory acclimatization induced by chronic intermittent hypoxia: a role for the carotid body in the pathophysiology of sleep apnea. Biol Res. 2005;38(4):335-40. doi: 10.4067/s0716-97602005000400004.

  PMID: 16579514 RESULT

• Williams B. The year in hypertension. J Am Coll Cardiol. 2008 May 6;51(18):1803-17. doi: 10.1016/j.jacc.2008.03.010. No abstract available.

  PMID: 18452788 RESULT

• Campos-Rodriguez F. Screening for sleep apnea in patients with resistant hypertension. Am J Hypertens. 2008 Jul;21(7):728. doi: 10.1038/ajh.2008.193. No abstract available.

  PMID: 18584016 RESULT

• Haentjens P, Van Meerhaeghe A, Moscariello A, De Weerdt S, Poppe K, Dupont A, Velkeniers B. The impact of continuous positive airway pressure on blood pressure in patients with obstructive sleep apnea syndrome: evidence from a meta-analysis of placebo-controlled randomized trials. Arch Intern Med. 2007 Apr 23;167(8):757-64. doi: 10.1001/archinte.167.8.757.

  PMID: 17452537 RESULT

• Phillips CL, Yee B, Yang Q, Villaneuva AT, Hedner J, Berend N, Grunstein R. Effects of continuous positive airway pressure treatment and withdrawal in patients with obstructive sleep apnea on arterial stiffness and central BP. Chest. 2008 Jul;134(1):94-100. doi: 10.1378/chest.07-3121. Epub 2008 Mar 17.

  PMID: 18347202 RESULT

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Hypertension

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• WAN-CHING Ho, M.D.

  Taiwan Society of Cardiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2012
• First Posted: October 3, 2012
• Study Start: May 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: August 1, 2013
• Last Updated: February 1, 2018

Record last verified: 2018-01

Locations

TW (1)