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

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Obstructive Sleep Apnea; Surveys and Questionnaires; Exhaled Breath Condensate

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.

• Study Type: Observational
• Enrollment (Actual): 1270

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100034
    • Jing Ma, Pro.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The volunteers were recruited residents from the Shi Cha Hai community of Beijing, China.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between risk for OSA and inflammation	The levels of EBC IL-6 and plasma SP-D were detected by ELISA. The levels of EBC IL-6 and plasma SP-D between the high- and low-OSA risk groups were compared.	through study completion, an average of 3 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comorbidities, inflammation and risk of sleep apnea	The prevalence of hypertension, coronary heart disease, and diabetes in the high-risk group for OSA than in the low-risk group were explored.	through study completion, an average of 3 year

Collaborators and Investigators

• Sponsor: Peking University First Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2009
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: March 28, 2021
• First Submitted That Met QC Criteria: April 1, 2021
• First Posted (Actual): April 6, 2021

Study Record Updates

• Last Update Posted (Actual): October 22, 2024
• Last Update Submitted That Met QC Criteria: October 21, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Inflammation; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 2021-116

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No