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.

Study Overview

• Status: Recruiting
• Conditions: Obstructive Sleep Apnea

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• Hong Kong
  • Please Select
    • Hong Kong, Please Select, Hong Kong
      • Recruiting
      • Chinese University of Hong
      • Contact: Susanna SS Ng, MBChB; Phone Number: (852) 35053493; Email: ssng@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients are recruited from the Respiratory Clinic at the Prince of Wales Hospital with clinical suspicion of sleep-disordered breathing. The Respiratory Clinic receives referral from hospital specialists and general practitioners. The clinical evaluation procedure includes an interview by a respiratory specialist followed by either an inpatient polysomnography or home polygraphic study according to the patients' clinical characteristics and preference in concordance of the guidelines from the American Academy of Sleep Medicine (AASM). Sleep records will be scored based on standardized criteria of AASM.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
incidence of Cardiovascular disease	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Montreal Cognitive Assessment score (MoCA)	MoCA scores range between 0 and 30. Higher scores mean a better cognitive function.	5 years
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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2020
• Primary Completion (Estimated): August 29, 2028
• Study Completion (Estimated): August 29, 2028

Study Registration Dates

• First Submitted: August 31, 2020
• First Submitted That Met QC Criteria: December 7, 2020
• First Posted (Actual): December 9, 2020

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 18, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: cognitive function
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: PrOSA study/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No