Ignite Creation Date:
2024-05-06 @ 3:59 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04832711
Status:
COMPLETED
Last Update Posted:
2021-04-06
First Post:
2021-03-28
Brief Title:
A Community Study of the Risk for Obstructive Sleep Apnea and Respiratory Inflammation in an Adult Chinese Population
Sponsor:
Peking University First Hospital
Organization:
Peking University First Hospital
Study Overview
Official Title:
A Community Study of the Risk for Obstructive Sleep Apnea and Respiratory Inflammation in an Adult Chinese Population
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We aimed to investigate the relationship between obstructive sleep apnea OSA risk and respiratory inflammation evaluated by the exhaled breath condensate EBCinterleukin-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 ELISAthrough 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
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 ELISAthrough 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 2000 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 12971527 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 05 and 15 ml of condensate After being pre-processed with argon flow of 025 Lmin 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
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 2000 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 12971527 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 05 and 15 ml of condensate After being pre-processed with argon flow of 025 Lmin 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None