Epidemiology and Intervention of Obstructive Sleep Apnea Based on Community

Completed

• Conditions: Hypertension; Obesity; Health Impairment; Quality of Life; Sleep Apnea, Obstructive; Hyperdiploid; Insomnia Chronic; Economic Problems; Compliance, Patient; Diabetes
• Interventions: Device: Auto-CPAP

• Registration Number: NCT03280914
• Lead Sponsor: Guangdong Provincial People's Hospital

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.

Detailed 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.

Study Timeline

• Study Start: 2017-08-01
• Study First Submitted: 2017-08-14
• Study First Submitted QC: 2017-09-12
• Study First Posted: 2017-09-13
• Status Verified: 2018-06
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Last Update Submitted: 2020-02-05
• Last Update Posted: 2020-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CPAP group	Auto-CPAP	Automatic Continuous Positive Airway Pressure treatment and usual care

Primary Outcome Measures

Name	Time	Method
Control rate of hypertension	From 1st Aug 2017 to 31st Dec 2020
Sleep quality	From 1st Aug 2017 to 31st Dec 2020	Sleep quality would be performed by Pittsburgh Sleep Quality Index.
Health assessment	From 1st Aug 2017 to 31st Dec 2020	Health assessment would be performed by 36-Item Short-Form Health Survey.
Psychological assessment	From 1st Aug 2017 to 31st Dec 2020	Psychological assessment would be performed by Hospital Anxiety and Depression Scale.

Secondary Outcome Measures

Name	Time	Method
Death from all-cause	From 1st Aug 2017 to 31st Dec 2025
Incidence of chronic diseases	From 1st Aug 2017 to 31st Dec 2025	Chronic diseases include hypertension, coronary heart disease, stroke and diabetes.
Medical cost	From 1st Aug 2017 to 31st Dec 2025	Medical fee, annually time of outpatient visit and hospitalization

Trial Locations

Locations (1)

Community of Huanghua Road; 🇨🇳 Guangzhou, China