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

June 20, 2025 updated by: Chulalongkorn University
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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand
        • Tidarat Somreusean

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: difficult to treat asthma
difficult to treat asthma run HST and PSG
Device: home sleep test
Apnealink air
Other Names:
  • polysonography

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assess the accuracy of type 3 home sleep apnea test (HSAT)
Time Frame: up to 1 months

number of participant who have same diagnosed OSA with type 3 HSAT compare to type 1 sleep test

  • AHI
  • ODI
up to 1 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2024

Primary Completion (Actual)

June 30, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

February 7, 2024

First Submitted That Met QC Criteria

April 1, 2025

First Posted (Actual)

April 8, 2025

Study Record Updates

Last Update Posted (Estimated)

June 25, 2025

Last Update Submitted That Met QC Criteria

June 20, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0722/66

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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