NCT06916858

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

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

February 7, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

February 7, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
9 months until next milestone

First Posted

Study publicly available on registry

April 8, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

June 25, 2025

Status Verified

March 1, 2025

Enrollment Period

5 months

First QC Date

February 7, 2024

Last Update Submit

June 20, 2025

Conditions

OSA

Keywords

asthmaOSAHSAThome sleep test

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • assess the accuracy of type 3 home sleep apnea test (HSAT)

    up to 1 months

Study Arms (1)

difficult to treat asthma

OTHER

difficult to treat asthma run HST and PSG

Device: home sleep test

Interventions

home sleep testDEVICE

Apnealink air

Also known as: polysonography
difficult to treat asthma

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tidarat Somreusean

Bangkok, Thailand

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
mask the result of home sleep test and Polysonography
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2024

First Posted

April 8, 2025

Study Start

February 7, 2024

Primary Completion

June 30, 2024

Study Completion

June 30, 2025

Last Updated

June 25, 2025

Record last verified: 2025-03

Locations

TH(1)