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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04659291

Enrollment

1000

Registered

2020-12-09

Start date

2020-08-30

Completion date

2028-08-29

Last updated

2024-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

cognitive function

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
incidence of Cardiovascular disease	5 years

Secondary

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

Countries

Hong Kong

Outcome results