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

NCT04659291 | Recruiting DMC

• 1 other identifier: PrOSA study/2020
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

cognitive function

Outcome Measures

Primary Outcomes (1)

• incidence of Cardiovascular disease

  5 years

Secondary Outcomes (2)

• Change of Montreal Cognitive Assessment score (MoCA)

  5 years

• Change of Epworth Sleepiness Score

  5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• already treated sleep apnea,
• a limited life expectancy due to illness unrelated to sleep apnea
• human immunodeficiency virus (HIV),
• advanced renal disease,
• uncontrolled malignancies

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Chinese University of Hong

Hong Kong, Please Select, Hong Kong

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 31, 2020
• First Posted: December 9, 2020
• Study Start: August 30, 2020
• Primary Completion (Estimated): August 29, 2028
• Study Completion (Estimated): August 29, 2028
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)