Epidemiology and Intervention of Obstructive Sleep Apnea Based on Community

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

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

Study Overview

• Status: Completed
• Conditions: Quality of Life; Sleep Apnea, Obstructive; Hypertension; Obesity; Diabetes; Fatigue Syndrome, Chronic; Compliance, Patient; Insomnia Chronic; Economic Problems; Health Impairment; Hyperdiploid
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 103

Contacts and Locations

Study Locations

• China
  • Guangzhou, China, 510000
    • Community of Huanghua Road

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients would be recruited from Community of Huanghua Road.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital
• Investigators: Principal Investigator: Qiong Ou, M.D., Guangdong Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: August 14, 2017
• First Submitted That Met QC Criteria: September 12, 2017
• First Posted (Actual): September 13, 2017

Study Record Updates

• Last Update Posted (Actual): February 6, 2020
• Last Update Submitted That Met QC Criteria: February 5, 2020
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: obstructive sleep apnea; community; real world
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Virus Diseases; Infections; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Signs and Symptoms, Respiratory; Encephalomyelitis; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Fatigue Syndrome, Chronic
• Other Study ID Numbers: GDREC2016275H(R1)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Previous research plan submitted to the Ethics Committee has stated the participant information not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No