Effect of Continuous Positive Airway Pressure (CPAP) on Systemic Blood Pressure, Coagulability and Carotid Intima-media Thickness in Patients With Sleep Apnea

NCT00300599 | Completed

• 1 other identifier: Resp/hui/2006/001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Sleep-disordered breathing (SDB) briefly means cessation of breathing during sleep at least 5 times per hour. Sleep-disordered breathing affects 9 to 24% of the middle-aged and overall 4% of the middle-aged males suffers from Obstructive sleep apnea syndrome (OSAS) i.e. SDB with associated daytime sleepiness. Several major epidemiological studies have shown that SDB is not only an independent risk factor for systemic hypertension but it is also associated with cardiovascular complications such as heart failure, stroke, and sudden death. The mechanisms for the linkage between Sleep-disordered breathing and cardiovascular diseases are not fully determined but surges in sympathetic nerve activity are seen at the end of each apneic episode accompanied by large rises in systemic arterial blood pressure (BP). The increased levels of muscle sympathetic nerve activity are diminished by nasal continuous positive airway pressure (CPAP) therapy. Numerous studies have found a hypercoagulable state in terms of increased clotting factor and platelet activities, and impaired fibrinolysis in coronary artery disease, ischaemic stroke, and sleep-disordered breathing. Common carotid artery intima-media thickness (IMT) has been shown to correlate with traditional vascular risk factors and may predict the likelihood of acute coronary events and stroke. Recently, carotid artery intima-media thickness has been shown to have positive correlations with the severity of sleep disordered breathing. Despite robust evidence showing improvement of symptoms, cognitive function and quality of life in patients with obstructive sleep apnea treated with nasal continuous positive airway pressure, there are conflicting short-term data whether continuous positive airway pressure can reduce blood pressure in patients with obstructive sleep apnea. This randomized controlled study aims to assess the long-term effects of nasal continuous positive airway pressure on 1) 24 hr systemic blood pressure; 2) Coagulation state; and 3) Carotid artery intimal media thickness.

Conditions

Obstructive Sleep Apnoea

Outcome Measures

Primary Outcomes (1)

• Blood Pressure measurement

  6 and 12 months

Secondary Outcomes (3)

• Changes in systolic and diastolic Blood pressure between the 2 groups at 6 & 12 months

  6 and 12 months

• serial changes of carotid intimal media thickness between the two treatment groups over 12 months

  12 months

• serial changes in haemostatic assays

  6 and 12 months

Study Arms (2)

A

ACTIVE COMPARATOR

Continue positive airway pressure

Device: Continuous Positive Airway pressure

B

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Continuous Positive Airway pressure DEVICE

Continuous positive pressure device with a time clock

A

Placebo OTHER

Placebo

B

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
• Apnoea Hypopnea index ≥5/hr on Polysomnography with Epworth Sleepiness Scale ≥10

You may not qualify if:

• Predominantly central sleep apnoea
• Recent myocardial infarction 3 months before the study
• Unstable angina
• Underlying malignancy
• Professional drivers and those handling dangerous machinery
• Patients will be considered dropouts if anti-hypertensive medication is accidentally changed by the patients or their general practitioners

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, 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: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: March 8, 2006
• First Posted: March 9, 2006
• Study Start: January 1, 2006
• Primary Completion: February 6, 2018
• Study Completion: August 6, 2019
• Last Updated: July 22, 2022

Record last verified: 2022-07

Locations

HK (1)