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Completed

NCT Number: NCT03280914

Epidemiology and Intervention of Obstructive Sleep Apnea Based on Community

This observational study in a real-world community was designed to perform epidemiological investigation and assess effect of CPAP intervention of obstructive sleep apnea.

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Key information

Conditions

Sleep Apnea, Obstructive Apnea Behavior Body Weight Cardiovascular Diseases Chronic Disease Compliance, Patient Diabetes Diabetes Mellitus Disease Attributes Dyssomnias Economic Problems Encephalomyelitis Endocrine System Diseases Fatigue Syndrome, Chronic Glucose Metabolism Disorders Health Behavior Health Impairment Hyperdiploid Hypertension Insomnia Chronic Mental Disorders Metabolic Diseases Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Quality of Life Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Treatment Adherence and Compliance Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Community of Huanghua Road

Guangzhou, 510000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Auto-CPAP

Device

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

Primary outcomes

  1. Health assessment

    Time frame: From 1st Aug 2017 to 31st Dec 2020

    Health assessment would be performed by 36-Item Short-Form Health Survey.

  2. Sleep quality

    Time frame: From 1st Aug 2017 to 31st Dec 2020

    Sleep quality would be performed by Pittsburgh Sleep Quality Index.

  3. Psychological assessment

    Time frame: From 1st Aug 2017 to 31st Dec 2020

    Psychological assessment would be performed by Hospital Anxiety and Depression Scale.

  4. Control rate of hypertension

    Time frame: From 1st Aug 2017 to 31st Dec 2020

Secondary outcomes

  1. Incidence of chronic diseases

    Time frame: From 1st Aug 2017 to 31st Dec 2025

    Chronic diseases include hypertension, coronary heart disease, stroke and diabetes.

  2. Death from all-cause

    Time frame: From 1st Aug 2017 to 31st Dec 2025

  3. Medical cost

    Time frame: From 1st Aug 2017 to 31st Dec 2025

    Medical fee, annually time of outpatient visit and hospitalization

Sponsors and collaborators

Lead sponsor

Guangdong Provincial People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 13, 2017
Registry last updated
Feb 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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