A Community Study of the Risk for Obstructive Sleep Apnea and Respiratory Inflammation in an Adult Chinese Population

NCT ID: NCT04832711

Last Updated: 2024-10-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1270 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2020-12-31

Brief Summary

We aimed to investigate the relationship between obstructive sleep apnea (OSA) risk and respiratory inflammation evaluated by the exhaled breath condensate （EBC）interleukin-6 IL-6 and plasma SP-D, based on the Berlin questionnaire (BQ) screening values in an adult, urban community in Beijing, China.

Volunteers aged >40 years were recruited from the Shichahai community of central Beijing. Their general information and disease history were recorded. OSA risk was assessed using the BQ. IL-6 in EBC and plasma SP-D were detected by enzyme-linked immunoassay (ELISA)through specimens collected on fasting. The differences in IL-6 and SP-D contents between high-risk and low-risk groups for OSA were compared, and the factors affecting their contents were analyzed.

Detailed Description

Subjects

The volunteers were recruited residents from the Shi Cha Hai community of Beijing, China. The inclusion criteria included individuals aged ≥40 years who had stayed in the community for at least 3 years and who had provided informed consent.

In contrast, the exclusion criteria were patients with known severe diseases who could not cooperate with the study, such as severe psychiatric diseases, chronic liver disease, heart failure, autoimmune disease, and chronic kidney disease; a history of pulmonary lobectomy or lung transplantation; and drug abuse or alcohol addiction.

Questionnaire survey and physical examination Community volunteers were surveyed for general information (name, sex, age, height, weight, etc.), history of previous common diseases, medication use, history of smoking, history of alcohol consumption, and occupation. All surveys were filled in the case report form of the study. A Chinese translation of the BQ was used to classify participants as high risk and low risk for OSA. COPD were diagnosed by a portable spirometer (Vitalograph copd-6). Other investigated diseases were self-reported by participants based on previous diagnosis. Physical examination included blood pressure, height, and weight measurements.

Sample collection and storage Venous blood and EBC were collected between 9 AM and 12 AM after fasting for >10 hours. The plasma collected in EDTA anticoagulated blood collection tubes was separated by centrifugation at 2,000 g for 15 min and stored at -80℃. The EBC collection was performed using an EBC collector (model number, EBC-5; patent number, ZL 2019 2 1297152.7, China).

The EBC collection was conducted as follows: After resting for 15 minutes and cleaning the oral cavity with water, participants were instructed to wear a nose clip and breathe calmly through a mouthpiece with a one-way valve, which was connected to an electrical condenser. Participants were asked to breathe through the device for 15 minutes to obtain between 0.5 and 1.5 ml of condensate. After being pre-processed with argon flow of 0.25 L/min for 10 minutes, the condensate was immediately fractional packed and transferred to special tubes and stored at -80℃. EBC equipment, collection procedures, and preservation complied with European Respiratory Society standards on breath analyses .

Measurement of biomarkers Enzyme-linked immunosorbent assay (ELISA) kits were used to measure the biomarkers in both EBC and plasma.

Conditions

Obstructive Sleep Apnea; Inflammation; Exhaled Breath Condensate; Surveys and Questionnaires

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

the low-risk group for OSA

A Chinese translation of the BQ was used to classify subjects into high risk and low risk for OSA.

No interventions assigned to this group

the high-risk group for OSA

A Chinese translation of the BQ was used to classify subjects into high risk and low risk for OSA.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria:

• The inclusion criteria included individuals aged ≥40 years who had stayed in the community for at least 3 years and who had provided informed consent.

Exclusion Criteria:

• the exclusion criteria were patients with known severe diseases who could not cooperate in the study, such as severe psychiatric diseases, chronic liver disease, heart failure, autoimmune disease, and chronic kidney disease, and a history of pulmonary lobectomy or lung transplantation and drug abuse or alcohol addiction.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Peking University First Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jing MA

Prof.&MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jing Ma, Pro.

Beijing, , China

Countries

China

Other Identifiers

2021-116

Identifier Type: -

Identifier Source: org_study_id