Endothelial Dysfunction, Monocyte Activation, and Vasculopathy in Patients With Obstructive Sleep Apnea (OSA) and Effect of 6-month CPAP Treatment

NCT01312168 | Unknown DMC

• 1 other identifier: 201012085RB
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This purpose of this study is to

1. 1.Determine the change in endothelial dependent vascular reactivity and vascular properties
2. 2.Determine the changes in monocytes activation
3. 3.Determine the change in pro-inflammatory status
4. 4.Investigate the effect of six-month CPAP therapy on the above changes in patients with OSA

Conditions

Sleep Apnea, Obstructive; Continuous Positive Airway Pressure; Endothelium; Inflammation; Vascular Function

Keywords

Cardiovascular disease; Continuous positive airway pressure; Endothelium; Vascular function; Inflammation; Sleep Apnea; Obstructive

Outcome Measures

Primary Outcomes (1)

• vascular reactivity of brachial artery and pulse wave velocity

  six months

Secondary Outcomes (2)

• percentage of adhesion molecule expression on monocytes

  six months

• levels of extra and intracellular cytokine

  six months

Study Arms (3)

Healthy non-OSA control

NO INTERVENTION

OSA receiving therapeutic CPAP

EXPERIMENTAL

Device: Therapeutic CPAP

OSA receiving subtherapeutic CPAP

SHAM COMPARATOR

Device: Subtherapeutic CPAP

Interventions

Therapeutic CPAP DEVICE

CPAP ventilator, optimal pressure decided by CPAP manual titration, daily use at sleep, six months

OSA receiving therapeutic CPAP

Subtherapeutic CPAP DEVICE

Subtherapeutic CPAP ventilator, pressure \<3 cmH2O, daily use at sleep, six months

OSA receiving subtherapeutic CPAP

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male patients aged 30 to 65 year who have daytime sleepiness (ESS\>=10)
• newly diagnosed OSA (AHI\>30/hr) by overnight PSG but never been treated

You may not qualify if:

• unwilling or unable to perform testing procedure
• past or current smoking history
• medical condition (including cardiovascular disease, chronic pulmonary disease, diabetes, endocrinologic disease, chronic renal failure, and psychiatric disease)
• systemic inflammatory conditions (system lupus erythematosus, rheumatoid arthritis, sarcoidosis, Crohn's disease, and ulcerative colitis)
• active neurologic event
• active infection two weeks prior to screening
• enrolled in other trials in the study period
• other sleep disorders
• sleepy driver
• using maintenance medications
• Control subjects
• Age-, sex-, body weight-, height-matched subjects with enrolled OSA patients
• non-sleepy
• no OSA confirmed by home sleep study (AHI\<5/hr)
• unwilling or unable to perform testing procedure

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• China Medical University, China: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Inflammation; Cardiovascular Diseases; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Peilin Lee, M.D.

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 8, 2011
• First Posted: March 10, 2011
• Study Start: March 1, 2011
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: December 14, 2016

Record last verified: 2016-12

Locations

TW (1)