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

NCT04832711 | Completed DMC

• 1 other identifier: 2021-116
• Study Type: observational
• Target: 1,270
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Comorbidities, inflammation and risk of sleep apnea

  through study completion, an average of 3 year

Study Arms (2)

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.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Jing Ma, Pro.

Beijing, 100034, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

exhaled breath condensate; plasma

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Inflammation

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.&MD

Study Record Dates

• First Submitted: March 28, 2021
• First Posted: April 6, 2021
• Study Start: May 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2020
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)