NCT03885440

Brief Summary

By clinical record review, this retrospective study aims to compare the different age groups of patients with obstructive sleep apnea, who were diagnosed and treated in Taipei Veterans General Hospital, Taiwan.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 21, 2019

Completed
18 days until next milestone

Study Start

First participant enrolled

April 8, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

April 9, 2019

Status Verified

April 1, 2019

Enrollment Period

3 months

First QC Date

March 16, 2019

Last Update Submit

April 8, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Apnea-hypopnea index(AHI)

    Counts of apnea/hypopnea events per hour

    through study completion, an average of 1 year

Secondary Outcomes (6)

  • Body mass index(BMI)

    through study completion, an average of 1 year

  • Posterior airway space (PAS)

    through study completion, an average of 1 year

  • Number of participants with comorbidities

    through study completion, an average of 1 year

  • Sleep efficiency

    through study completion, an average of 1 year

  • arousal index

    through study completion, an average of 1 year

  • +1 more secondary outcomes

Study Arms (4)

Young adult, without OSAS

20\<=Age\<40 years old, apnea-hypopnea index(AHI)\<5

Other: Age

Young adult, with OSAS

20\<=Age\<40 years old, AHI\>=5

Other: AgeOther: OSA

older adult, without OSAS

Age\>=40 years old, AHI\<5

older adult, with OSAS

Age\>=40 years old, AHI\>=5

Other: OSA

Interventions

AgeOTHER

Age\<40 years old is chosen as the cutoff value.

Young adult, with OSASYoung adult, without OSAS
OSAOTHER

The diagnosis of OSA (obstructive sleep apnea) relies on polysomnographic data showing an apnea-hypopnea index at least 5/hr with compatible symptoms.

Young adult, with OSASolder adult, with OSAS

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with sleep complaints

You may qualify if:

  • Patients with sleep complaints and received PSG in sleep center in Taipei Veterans General Hospital

You may not qualify if:

  • Patients who ever received treatment for OSA
  • Patients cannot tolerate PSG examination
  • Patients cannot complete the questionnaires before and after PSG examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chest department, Taipei Veteran General Hospital

Taipei, 112, Taiwan

RECRUITING

Related Publications (1)

  • Chiu HY, Chou KT, Su KC, Lin FC, Liu YY, Shiao TH, Chen YM. Obstructive sleep apnea in young Asian adults with sleep-related complaints. Sci Rep. 2022 Nov 29;12(1):20582. doi: 10.1038/s41598-022-25183-5.

MeSH Terms

Interventions

Aging

Intervention Hierarchy (Ancestors)

Growth and DevelopmentPhysiological Phenomena

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Medical Doctor

Study Record Dates

First Submitted

March 16, 2019

First Posted

March 21, 2019

Study Start

April 8, 2019

Primary Completion

June 30, 2019

Study Completion

September 30, 2019

Last Updated

April 9, 2019

Record last verified: 2019-04

Locations