NCT04186078

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
249mo left

Started Nov 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress24%
Nov 2019Dec 2046

Study Start

First participant enrolled

November 11, 2019

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 27, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 4, 2019

Completed
26 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2045

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2046

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

26.1 years

First QC Date

November 27, 2019

Last Update Submit

April 21, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • The number of deaths

    Median follow up of 15 years

  • The cause of death

    Median follow up of 15 years

Other Outcomes (1)

  • Change of FEV1 and FVC in patients with OSA

    Median follow up of 5 years

Study Arms (3)

obstructive sleep apnea (OSA)

5 or more predominantly obstructive respiratory events \[obstructive and mixed apneas, hypopneas or respiratory effort-related arousals (RERAs)\] per hour of sleep during a PSG or per hour of monitoring (respiratory polygraphy)

central sleep apnea (CSA)

PSG shows all of the following: 1. 5 or more central apneas and/or central hypopneas per hour of sleep. 2. The number of central and/or central hypopneas is \> 50% of the total number of apneas and hypopneas.

control

apnea-hypopnea index \< 5 per hour of sleep during a PSG or per hour of monitoring (respiratory polygraphy)

Eligibility Criteria

Age19 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

For only participants with the informed consent of donating blood, their blood samples (serum, plasma, and buffy coat) will be collected and stored in the Seoul National University Hospital-Human Biobank (SNUH-HUB).

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Jaeyoung Cho, M.D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaeyoung Cho, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 27, 2019

First Posted

December 4, 2019

Study Start

November 11, 2019

Primary Completion (Estimated)

December 1, 2045

Study Completion (Estimated)

December 1, 2046

Last Updated

April 24, 2026

Record last verified: 2026-04

Locations