Clinical Characteristics of Patients With Sleep Apnea in Korea

Sleep Apnea Syndromes Clinical Trial

Official title:

Clinical Characteristics of Patients With Sleep Apnea in Korea: a Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04186078
• Other study ID #: 19071511050
• Status: Recruiting
• Start date: November 11, 2019
• Est. completion date: December 2046

Study information

• Verified date: November 2023
• Source: Seoul National University Hospital
• Contact: Jaeyoung Cho, M.D.
• Phone: +82-2-2072-2503
• Email: apricot6[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Sleep-disordered breathing including obstructive sleep apnea (OSA) is an extremely common medical disorder associated with important morbidity. The purpose of this study is to understand the clinical features and course of patients with sleep apnea in Korea. Participants who are suspected of sleep apnea due to symptoms such as snoring, witnessed apneas, waking up with a choking sensation, excessive sleepiness, non-restorative sleep, difficulty initiating or maintaining sleep, fatigue or tiredness, and morning headache will be prospectively recruited at the outpatient clinic of Seoul National University Hospital. After polysomnography (PSG) or respiratory polygraphy, patients with sleep apnea including OSA and central sleep apnea (CSA) will be followed regularly. Participants not having sleep apnea (apnea-hypopnea index < 5/hour) will only have a baseline visit. For only participants with the informed consent of donating blood, their blood samples will be collected and stored in the Seoul National University Hospital-Human Biobank (SNUH-HUB).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2046
• Est. primary completion date: December 2045
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Participants who are suspected of sleep apnea due to symptoms such as snoring, witnessed apneas, waking up with a choking sensation, excessive sleepiness, non-restorative sleep, difficulty initiating or maintaining sleep, fatigue or tiredness, and morning headache

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of FEV1 and FVC in patients with OSA	Change of forced expiratory volume in 1 s (FEV1) and forced vital capacity (FVC) in patients with OSA	Median follow up of 5 years
Primary	The number of participants with adherence to positive airway pressure (PAP) therapy	PAP adherence is defined as the use of PAP therapy for =4 h/night on =70% of nights	Median follow up of 2 years
Secondary	The number of deaths	The number of deaths	Median follow up of 15 years
Secondary	The cause of death	The cause of death	Median follow up of 15 years