Effect of Nasal Continuous Positive Airway Pressure (CPAP) Blood Pressure and Vascular Endothelial Growth Factor in Obstructive Sleep Apnea Syndrome

NCT00300872 | Completed DMC

• 1 other identifier: Resp/hui/2006/002
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Sleep-disordered breathing (SDB) briefly means cessation of breathing during sleep at least 5 times per hour. SDB is a common disorder affecting 9 to 24% of the middle-aged and overall 4% of the middle-aged male population suffers from the Obstructive sleep apnea syndrome (OSA) i.e. Sleep-disordered breathing (SDB) with associated daytime sleepiness. Several major epidemiological studies have shown that SDB is not only an independent risk factor for hypertension but it is also strongly associated with heart failure and stroke. The mechanism for the linkage between SDB and cardiovascular consequences is not fully determined. Vascular endothelial growth factor (VEGF) is a soluble 34-46 kD angiogenic heparin-binding glycoprotein. This cytokine regulates multiple endothelial cell functions including vascular permeability and vascular tone and some data suggest that it may contribute to the atherosclerotic process. Recent studies have shown increased plasma and serum concentrations of Vascular endothelial growth factor (VEGF) in patients with OSA and there were correlations between VEGF concentrations and the severity of OSA, as indexed by the minimum oxygen saturation level and the frequency of the upper airway obstruction per hour of sleep. A recent non-randomized study with a small sample size has shown a significant decrease in Vascular endothelial growth factor (VEGF) concentrations in patients in whom nocturnal hypoxia improved after 1 year of nasal continuous positive airway pressure (CPAP) therapy. Despite robust evidence showing improvement of symptoms, cognitive function and quality of life in obstructive sleep apnea (OSA) patients treated with nasal CPAP, there are nevertheless conflicting data whether Continuous positive airway pressure (CPAP) can reduce daytime blood pressure (BP) in patients with OSA. Two randomized placebo controlled studies have shown reduction of 24-hr systolic and diastolic blood pressure (BP) in obstructive sleep apnea (OSA) patients after 1 month of nasal continuous positive airway pressure (CPAP) therapy while other investigators have shown no such benefit. This randomized, sham-placebo controlled study aims to assess 1) the effect of nasal continuous positive airway pressure (CPAP) over a period of 3 months on 24 hr blood pressure (BP); and 2) whether any change in BP and plasma Vascular endothelial growth factor (VEGF) is related to the baseline severity of obstructive sleep apnea (OSA) and continuous positive airway pressure (CPAP) compliance.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Change in 24 hr mean blood pressure at 3 months

  baseline and 3 months

Secondary Outcomes (3)

• Changes in systolic and diastolic blood pressure, changes in mean blood pressure awake and asleep, change in plasma Vascular endothelia growth factor (VEGF) at 3 months

  baseline and 3 months

• Whether any change in blood pressure or vascular endothelial growth factor (VEGF) is related to the baseline severity of obstructive sleep apnea (OSA) and continuous positive airway pressure (CPAP) compliance over 3 months

  baseline and 3 months

• Epworth Sleepiness Scale (ESS) and Calgary Sleep Apnea Quality of Life Index (SAQLI) at 1 month and 3 months.

  baseline and 3 months

Study Arms (2)

1

ACTIVE COMPARATOR

Continuous positive airway pressure (CPAP)

Device: Continuous positive airway pressure (CPAP)

2

SHAM COMPARATOR

Sham Continuous positive airway pressure (CPAP)

Device: Sham Continuous positive airway pressure (CPAP)

Interventions

Continuous positive airway pressure (CPAP) DEVICE

Continuous positive airway pressure (CPAP) - Horizon LT 8001 Continuous positive airway pressure (CPAP) device.

1

Sham Continuous positive airway pressure (CPAP) DEVICE

Sham Continuous positive airway pressure (CPAP) - Continuous positive airway pressure (CPAP) units set to the lowest pressure (4 cm of water pressure) and 6 extra 4mm holes will be inserted in the collar of the main tubing at the end of the mask to allow air escape and to prevent carbon dioxide rebreathing.

2

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 20 to 80 yrs
• Apnea hypopnea index (AHI) \> 10/hr on Polysomnograph (PSG) with symptoms of obstructive sleep apnea (OSA) as described previously
• Epworth Sleepiness Scale (ESS) \>10
• Patients with hypertension will still be eligible to enter and continue the study as long as there is no alteration of anti-hypertensive medications during the study period

You may not qualify if:

• Patients having problems staying awake during driving, shift work
• Recent myocardial infarction
• Unstable angina
• Underlying malignancy

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Shatin, New Territories, Hong Kong

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• David S Hui, MD

  Chinese University of Hong Kong

  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: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: March 8, 2006
• First Posted: March 10, 2006
• Study Start: January 1, 2005
• Primary Completion: August 6, 2019
• Study Completion: August 6, 2019
• Last Updated: January 27, 2021

Record last verified: 2021-01

Locations

HK (1)