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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03280914
Other study ID # GDREC2016275H(R1)
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2017
Est. completion date December 31, 2019

Study information

Verified date June 2018
Source Guangdong Provincial People's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Patients with obstructive sleep apnea receiving CPAP or not would be observed in years. Primarily Impact of CPAP on health assessment andx control rate of hypertension would evaluated.


Recruitment information / eligibility

Status Completed
Enrollment 103
Est. completion date December 31, 2019
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

1) AHI >= 5 events/h

Exclusion Criteria:

1. 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

2. Any condition potentially precluding follow-up visits, such as sereve insomnia, cognitive behavioral disorder, and others

3. Patients receiving CPAP treatment

Study Design


Intervention

Device:
Auto-CPAP
Automatic Continuous Positive Airway Pressure treatment is the first-line treatment of obstructive sleep apnea

Locations

Country Name City State
China Community of Huanghua Road Guangzhou

Sponsors (1)

Lead Sponsor Collaborator
Guangdong Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Health assessment Health assessment would be performed by 36-Item Short-Form Health Survey. From 1st Aug 2017 to 31st Dec 2020
Primary Sleep quality Sleep quality would be performed by Pittsburgh Sleep Quality Index. From 1st Aug 2017 to 31st Dec 2020
Primary Psychological assessment Psychological assessment would be performed by Hospital Anxiety and Depression Scale. From 1st Aug 2017 to 31st Dec 2020
Primary Control rate of hypertension From 1st Aug 2017 to 31st Dec 2020
Secondary Incidence of chronic diseases Chronic diseases include hypertension, coronary heart disease, stroke and diabetes. From 1st Aug 2017 to 31st Dec 2025
Secondary Death from all-cause From 1st Aug 2017 to 31st Dec 2025
Secondary Medical cost Medical fee, annually time of outpatient visit and hospitalization From 1st Aug 2017 to 31st Dec 2025
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