Prospective Study on Patients With Obstructive Sleep Apnea in Hong Kong (PrOSA)

Obstructive Sleep Apnea Clinical Trial

Official title:

Prospective Study on Patients With Obstructive Sleep Apnea in Hong Kong (PrOSA)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04659291
• Other study ID #: PrOSA study/2020
• Status: Recruiting
• Start date: August 30, 2020
• Est. completion date: August 29, 2028

Study information

• Verified date: February 2024
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Obstructive sleep apnea syndrome (OSAS) is a common disorder with prevalence rates of at least 4% among the middle-aged male Caucasians and Hong Kong (HK) Chinese populations. It is characterized by repetitive episodes of upper airway obstruction, causing intermittent hypoxia, sleep fragmentation, disabling daytime sleepiness, impaired cognitive function and poor health status. OSAS patients are at increased risks of non-fatal and fatal cardiovascular morbidity and mortality including sudden death, in addition to being more prone to road traffic accidents. However, there is no long term follow up of patients with OSAS on the incidence of cardiovascular disease, compliance on the therapy and the impact of the quality of life. The study is aimed to carry out a prospective observational study assessing the role of OSAS as a possible cause of increased cardiovascular risk and cognitive decline.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: August 29, 2028
• Est. primary completion date: August 29, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• suspected obstructive sleep apnea syndrome

• aged 18 or above

• must be able to speak, read and understand Chinese or English

• possess the ability to respond to questions and follow instructions.

Exclusion Criteria:

• already treated sleep apnea,

• a limited life expectancy due to illness unrelated to sleep apnea

• human immunodeficiency virus (HIV),

• advanced renal disease,

• uncontrolled malignancies

• documented alcohol or drug abuse up to 1 year prior to inclusion in the study.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
Hong Kong	Chinese University of Hong	Hong Kong	Please Select

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of Cardiovascular disease		5 years
Secondary	Change of Montreal Cognitive Assessment score (MoCA)	MoCA scores range between 0 and 30. Higher scores mean a better cognitive function.	5 years
Secondary	Change of Epworth Sleepiness Score	The Epworth Sleepiness Scale can be used to assess daytime sleepiness. The scores range between 0 and 24. Higher scores mean more sleepiness.	5 years