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

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chinese University of Hong

Hong Kong, Please Select

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Primary outcomes

incidence of Cardiovascular disease

Time frame: 5 years

Secondary outcomes

Change of Montreal Cognitive Assessment score (MoCA)

Time frame: 5 years

MoCA scores range between 0 and 30. Higher scores mean a better cognitive function.
Change of Epworth Sleepiness Score

Time frame: 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.

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Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start: 2020
Primary completion: 2028
Study completion: 2028
First posted: Dec 9, 2020
Registry last updated: Feb 20, 2024

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.

Published trials that share one or more normalized conditions with this study.

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