Markers in Exhaled Breath Condensate in Obstructive Sleep Apnoea (OSA) Patients

NCT00287638 | Completed

• 1 other identifier: Resp/ko/2006/002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with obstructive sleep apnoea (OSA) have repetitive episodes of partial or complete upper airway obstruction during sleep. This leads to sleep fragmentation and symptoms like excessive daytime sleepiness and impaired psychosocial well-being. More evidence now suggested OSA is associated with cardiovascular diseases like hypertension, myocardial infarction, pulmonary hypertension and stroke. The upper airway structure and function are altered in OSA. Some studies suggested that an increase in the levels of systemic biomarkers of inflammation and oxidative stress in patients with OSA. So far, there is only very limited data on non-invasive monitoring of inflammation involved in the upper airway of OSA patients. The inflammatory mechanisms involved in the upper airway may give some insights to the systemic effect, like cardiovascular complications, of OSA. Measurement of the constituents of exhaled breath and exhaled breath condensate (EBC) is a non-invasive method to assess the degree of inflammation of the airway. Exhaled nitric oxide (eNO) can be measured with the subject exhaling to a mouthpiece connected to a machine measuring real-time eNO level. With the subject exhaling to a cooling unit, EBC can be collected as liquid is formed as a result of condensation. This study will assess the eNO in exhaled breath, oxidative stress marker (8-isoprostane) and cellular inflammatory markers (eotaxin, monocyted derived chemokine, growth related oncogene- alpha, monocyte chemoattractant protein-1) in the EBC and blood of OSA patients before and after 1 night and 3 months of continuous positive airway pressure treatment.

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive sleep apnea

Outcome Measures

Primary Outcomes (1)

• Changes in the biomarkers in breath over a period of time in subjects with CPAP and no CPAP treatment for the OSA

  3 months

Study Arms (2)

1

ACTIVE COMPARATOR

CPAP

Device: CPAP

2

PLACEBO COMPARATOR

no CPAP

Device: placebo

Interventions

CPAP DEVICE

Continuous positive pressure device with a time clock

1

placebo DEVICE

no CPAP

2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients will be recruited upon admission for sleep study under the Division of Respiratory Medicine, Prince of Wales Hospital.
• Patients who are aged 18 to 60 will be recruited.

You may not qualify if:

• Known history of respiratory disease that will affect inflammatory markers in EBC like asthma, chronic obstructive pulmonary disease and bronchiectasis.
• Upper or lower respiratory tract infection within 6 weeks from the study.
• Current smokers, or ex-smoker who quitted for less than a year.
• Pregnant subjects.
• Any form of malignancies or serious medical illness that will affect the survival of the subject significantly in 1 year period.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, N.T., 000, Hong Kong

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Fanny WS Ko, MBChB

  CUHK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 6, 2006
• First Posted: February 7, 2006
• Study Start: January 1, 2006
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: January 22, 2010

Record last verified: 2010-01

Locations

HK (1)