Epidemiology and Intervention of Obstructive Sleep Apnea Based on Community

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03280914
• Other study ID #: GDREC2016275H(R1)
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Apnea
• Compliance, Patient
• Diabetes
• Economic Problems
• Fatigue
• Fatigue Syndrome, Chronic
• Health Impairment
• Hyperdiploid
• Hypertension
• Insomnia Chronic
• Obesity
• Quality of Life
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

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