OSANCT06916858
Prevalence of OSA and Diagnostic Accuracy of Type 3 Home Sleep Test in Difficult-to-treat Asthma
A study testing home sleep test in people with OSA, run by Chulalongkorn University at 1 site in Thailand.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- OSA
- What is being tested?
- home sleep test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteThailand
- Study dates
- 7 Feb 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- difficult-to-treat asthma .
- Patients aged 18 years or older
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- OSA
- Being tested
- home sleep test
- Keywords
- asthma, OSA, HSAT, home sleep test
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home sleep testDevice
Also called polysonography
Apnealink air
| Study group | Role | What they receive |
|---|---|---|
| difficult to treat asthma | Other | difficult to treat asthma run HST and PSG Receives: Device: home sleep test |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of OSA in patients with difficult-to-treat asthma
prevalence of OSA in patients with difficult-to-treat asthma
Measured: up to 4 months
Secondary outcomes (1)
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
Measured: up to 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start7 Feb 2024
- Primary completion30 Jun 2024
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OSAStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06916858
- Sponsor's protocol ID
- 0722/66
- Status last verified
- Mar 2025
- First submitted
- 7 Feb 2024
- Last updated
- 25 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of OSA and Diagnostic Accuracy of Type 3 Home Sleep Test in Difficult-to-treat Asthma
- ClinicalTrials.gov ID
- NCT06916858
- Acronym / sponsor ID
- 0722/66
- Conditions
- OSA
- Keywords
- asthma, OSA, HSAT, home sleep test
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 8 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| difficult to treat asthma | Other | Device: home sleep testdifficult to treat asthma run HST and PSG |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- difficult-to-treat asthma .
- Patients aged 18 years or older
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| home sleep testAlso: polysonographyApnealink air | Device | difficult to treat asthma |
Primary outcome
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
1 secondary outcome
assess the accuracy of type 3 home sleep apnea test (HSAT)
Time frame: up to 1 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing home sleep test in people with OSA, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of OSA in patients with difficult-to-treat asthma (time frame: up to 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.