Prevalence of OSA and Diagnostic Accuracy of Type 3 Home... | NCT06916858

Studies
Prevalence of OSA and Diagnostic Accuracy of Type 3 Home Sleep Test in Difficult-to-treat Asthma

NCT06916858

Sponsor

Chulalongkorn University

Status

Active, not recruiting

Last Update Posted

Jun 25, 2025Actual

Enrollment

37Estimated

Phase

Not Applicable

Conditions

Interventions

home sleep test

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 7, 2024Actual

Primary Completion Date

Jun 30, 2024Actual

Completion Date

Jun 30, 2025Estimated

First Submitted Date

Feb 7, 2024

First Submission Date that Met QC Criteria

Apr 1, 2025

First Posted Date

Apr 8, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 20, 2025

Last Update Posted Date

Jun 25, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

cross sectional cohort study enroll Patients diagnosed with difficult-to-treat asthma, aged over 18 years, and experiencing persistent symptoms as assessed by the Asthma Control Test (ACT) underwent type 1 in-laboratory polysomnography and type 3 HSAT within 1 month apart

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

37Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
difficult to treat asthma	Other	difficult to treat asthma run HST and PSG	Device: home sleep test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
home sleep test	Device	Apnealink air	difficult to treat asthma	polysonography

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
prevalence of OSA in patients with difficult-to-treat asthma	prevalence of OSA in patients with difficult-to-treat asthma	up to 4 months

Secondary Outcomes

Measure	Description	Time Frame
assess the accuracy of type 3 home sleep apnea test (HSAT)	number of participant who have same diagnosed OSA with type 3 HSAT compare to type 1 sleep test AHI ODI	up to 1 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

difficult-to-treat asthma .
Patients aged 18 years or older

Exclusion Criteria:

Patients or volunteers unable to undergo type 1 and type 3 sleep studies,
Patients with symptoms compatible with other sleep disorders,
Patients with a history of or current stroke or transient ischemic attack and Other chronic respiratory diseases.
Patients diagnosed with obstructive sleep apnea

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided