Epidemiology and Intervention of Obstructive Sleep Apnea Based on Community

Sponsor

Guangdong Provincial People's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03280914

Collaborator

(none)

103

Enrollment

Location

Actual Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea, Obstructive Hypertension Obesity Diabetes Hyperdiploid Fatigue Syndrome, Chronic Insomnia Chronic Quality of Life Economic Problems Compliance, Patient Health Impairment	Device: Auto-CPAP

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 Design

Study Type:

Observational

Actual Enrollment :

103 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Epidemiology and Intervention of Obstructive Sleep Apnea Based on Community: a Real World Study

Actual Study Start Date :

Aug 1, 2017

Actual Primary Completion Date :

Dec 31, 2019

Actual Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
CPAP group Automatic Continuous Positive Airway Pressure treatment and usual care	Device: Auto-CPAP Automatic Continuous Positive Airway Pressure treatment is the first-line treatment of obstructive sleep apnea
Usual care group Usual care without Continuous Positive Airway Pressure treatment

Arm

Intervention/Treatment

CPAP group

Automatic Continuous Positive Airway Pressure treatment and usual care

Device: Auto-CPAP

Automatic Continuous Positive Airway Pressure treatment is the first-line treatment of obstructive sleep apnea

Usual care group

Usual care without Continuous Positive Airway Pressure treatment

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

AHI >= 5 events/h

Exclusion Criteria:

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