Epidemiology and Intervention of Obstructive Sleep Apnea Based on Community
1 other identifier
observational
103
1 country
1
Brief Summary
This observational study in a real-world community was designed to perform epidemiological investigation and assess effect of CPAP intervention of obstructive sleep apnea.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2017
CompletedFirst Submitted
Initial submission to the registry
August 14, 2017
CompletedFirst Posted
Study publicly available on registry
September 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedFebruary 6, 2020
June 1, 2018
2.4 years
August 14, 2017
February 5, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Health assessment
Health assessment would be performed by 36-Item Short-Form Health Survey.
From 1st Aug 2017 to 31st Dec 2020
Sleep quality
Sleep quality would be performed by Pittsburgh Sleep Quality Index.
From 1st Aug 2017 to 31st Dec 2020
Psychological assessment
Psychological assessment would be performed by Hospital Anxiety and Depression Scale.
From 1st Aug 2017 to 31st Dec 2020
Control rate of hypertension
From 1st Aug 2017 to 31st Dec 2020
Secondary Outcomes (3)
Incidence of chronic diseases
From 1st Aug 2017 to 31st Dec 2025
Death from all-cause
From 1st Aug 2017 to 31st Dec 2025
Medical cost
From 1st Aug 2017 to 31st Dec 2025
Study Arms (2)
CPAP group
Automatic Continuous Positive Airway Pressure treatment and usual care
Usual care group
Usual care without Continuous Positive Airway Pressure treatment
Interventions
Automatic Continuous Positive Airway Pressure treatment is the first-line treatment of obstructive sleep apnea
Eligibility Criteria
Patients would be recruited from Community of Huanghua Road.
You may qualify if:
- \) AHI \>= 5 events/h
You may not qualify if:
- Any condition which in the opinion of researched makes the eligible participants unsuitable for this study, such as severe COPD, heart failure in NYHA class III to IV, and others
- Any condition potentially precluding follow-up visits, such as sereve insomnia, cognitive behavioral disorder, and others
- Patients receiving CPAP treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Community of Huanghua Road
Guangzhou, 510000, China
Biospecimen
Serum lipid, glucose.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Qiong Ou, M.D.
Guangdong Provincial People's Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2017
First Posted
September 13, 2017
Study Start
August 1, 2017
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
February 6, 2020
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will not share
Previous research plan submitted to the Ethics Committee has stated the participant information not be shared.