Obstructive Sleep ApneaNCT06314477
Effect of CPAP Treatment in Patients With Severe Uncontrolled Asthma: The ASTHMA-SLEEP Trial
A study testing CPAP treatment and Hygienic and dietary advice in people with Obstructive Sleep Apnea and Asthma, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
The aim of the study is to evaluate the impact of CPAP treatment on asthma control in patients with severe uncontrolled asthma and obstructive sleep apnea (OSA) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Asthma
- What is being tested?
- CPAP treatment and Hygienic and dietary advice
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteSpain
- Study dates
- 29 Feb 2024to Dec 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- Diagnosis of severe uncontrolled asthma according to the criteria of the Spanish Asthma Management Guide (GEMA) or the Global Initiative for Asthma (GINA) and no hospitalizations the month prior to inclusion in the study.
- Apnea hypopnea rate greater than or equal to 15/hour
- Punctuation in the Epworth Sleepiness Scale ≤10
- Obtaining informed consent.
Who cannot join
- Previous treatment with CPAP
- Patient with central sleep apnea or Cheyne-Stokes respiration
- Other sleep disorders: narcolepsy, restless leg syndrome, chronic insomnia,
- Resistant hypertension
- Active Smoking
- Unstable comorbidities or medications may interfere with asthma control
Show all 9Show fewer
- Pregnancy
- Any process that reduces life expectancy to <1 year,
- Any medical or social factor that may limit CPAP compliance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Clinic Barcelona
Barcelona, Spain, 08036
About this study
Official title: Effect of CPAP Treatment on Asthma Control in Patients With Severe Uncontrolled Asthma and Obstructive Sleep Apnea: The ASTHMA-SLEEP Study
The aim of the study is to evaluate the impact of CPAP treatment on asthma control in patients with severe uncontrolled asthma and obstructive sleep apnea (OSA)
Read the detailed description
Background: The prevalence of obstructive sleep apnea (OSA) is high in patients with severe uncontrolled asthma and can worsen asthma control. Previous observational studies demonstrated that CPAP treatment could improve control in patients with mild-moderate asthma. Nevertheless, there are no studies in patients with severe uncontrolled asthma.
Primary objective: To evaluate the impact of CPAP treatment on asthma control in patients with severe uncontrolled asthma and OSA.
Methodology: Multicenter, prospective, randomized, controlled clinical trial with parallel groups in subjects with severe uncontrolled asthma who are older than 18 years and without sleepiness (Epworth sleepiness scale score ≤10). All included subjects will undergo conventional polysomnography and those with an apnea-hypopnea index (AHI) ≥15/hour will be randomized in a 1:1 ratio to receive conservative treatment or conservative treatment plus CPAP. Monitoring will be carried out during12 months. Patients will be evaluated at inclusion, at 1 month, 6 and 12 months.
- Conditions
- Obstructive Sleep Apnea, Asthma
- Being tested
- CPAP treatment, Hygienic and dietary advice
- Medical subject headings
- Sleep Apnea, Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP treatmentDevice
Subjects allocated to this arm will receive continuous positive airway pressure (CPAP)
Hygienic and dietary adviceOther
Subjects allocated to this arm will receive hygienic and dietary counselling
| Study group | Role | What they receive |
|---|---|---|
| Conservative treatment | Active comparator | Subjects allocated to this arm will receive hygienic and dietary measures counselling Receives: Other: Hygienic and dietary advice |
| CPAP treatment | Experimental | Subjects allocated to this arm will receive treatment with continuous positive airway pressure (CPAP) Receives: Device: CPAP treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma control questionnaire
To evaluate the impact of CPAP treatment on asthma control based on the Asthma control questionnaire (ACQ)
Measured: 12 months
Asthma control test
To evaluate the impact of CPAP treatment on asthma control based on the Asthma control test (ACT)
Measured: 12 months
Secondary outcomes (6)
Lung function- forced expiratory volume in the first second (FEV1) in spirometry
To evaluate the impact of CPAP treatment on FEV1 (ml) on spirometry
Measured: 12 months
Lung function-forced vital capacity (FVC) in spriometry
To evaluate the impact of CPAP treatment on FVC (ml) on spirometry
Measured: 12 months
Prevalence of OSA in severe uncontrolled asthma
Determine the prevalence of OSA in patients with severe uncontrolled asthma
Measured: Baseline
Inflammatory profile
Plasma proteins from peripheral blood samples will be used to analyze an inflammatory panel using a high-throughput, multiplex immunoassay technology based on Proximity Extension Assays (PEA) at baseline and after CPAP treatment
Measured: Baseline, 6 and 12 months
Quality of life (Abbreviated Asthma Quality of life Questionnaire- mini-AQLQ questionnaire)
Study whether OSA ans its treatment affects quality of life in subjects with severe uncontrolled asthma based on the punctuation obtained in the mini-AQLQ questionnaire. Higher scores indicate better quality of life
Measured: 12 months
Exacerbations
Number of excarbations the year before starting the study and at 12-month of treatment in both arms
Measured: From enrollment to the end of the study at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start29 Feb 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mireia Dalmases, Hospital Clinic of Barcelona
- Investigators
- Mireia Dalmases, MD, Principal investigator, Hospital Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314477
- Sponsor's protocol ID
- HCB/2022/1204
- Status last verified
- Sep 2026
- First submitted
- 25 Feb 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized IPD will be available upon reasonable request following publication of the study results. Requests will be valuated by the study team and be subject to applicable ethical, legal and data portection requeriments.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of CPAP Treatment on Asthma Control in Patients With Severe Uncontrolled Asthma and Obstructive Sleep Apnea: The ASTHMA-SLEEP Study
- ClinicalTrials.gov ID
- NCT06314477
- Acronym / sponsor ID
- HCB/2022/1204
- Conditions
- Obstructive Sleep Apnea, Asthma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Mar 2024 (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.
The aim of the study is to evaluate the impact of CPAP treatment on asthma control in patients with severe uncontrolled asthma and obstructive sleep apnea (OSA)
Detailed description
Background: The prevalence of obstructive sleep apnea (OSA) is high in patients with severe uncontrolled asthma and can worsen asthma control. Previous observational studies demonstrated that CPAP treatment could improve control in patients with mild-moderate asthma. Nevertheless, there are no studies in patients with severe uncontrolled asthma.
Primary objective: To evaluate the impact of CPAP treatment on asthma control in patients with severe uncontrolled asthma and OSA.
Methodology: Multicenter, prospective, randomized, controlled clinical trial with parallel groups in subjects with severe uncontrolled asthma who are older than 18 years and without sleepiness (Epworth sleepiness scale score ≤10). All included subjects will undergo conventional polysomnography and those with an apnea-hypopnea index (AHI) ≥15/hour will be randomized in a 1:1 ratio to receive conservative treatment or conservative treatment plus CPAP. Monitoring will be carried out during12 months. Patients will be evaluated at inclusion, at 1 month, 6 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative treatment | Active comparator | Other: Hygienic and dietary adviceSubjects allocated to this arm will receive hygienic and dietary measures counselling |
| CPAP treatment | Experimental | Device: CPAP treatmentSubjects allocated to this arm will receive treatment with continuous positive airway pressure (CPAP) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >18 years
- Diagnosis of severe uncontrolled asthma according to the criteria of the Spanish Asthma Management Guide (GEMA) or the Global Initiative for Asthma (GINA) and no hospitalizations the month prior to inclusion in the study.
- Apnea hypopnea rate greater than or equal to 15/hour
- Punctuation in the Epworth Sleepiness Scale ≤10
- Obtaining informed consent.
Key exclusion criteria (9 listed)
- Previous treatment with CPAP
- Patient with central sleep apnea or Cheyne-Stokes respiration
- Other sleep disorders: narcolepsy, restless leg syndrome, chronic insomnia,
- Resistant hypertension
- Active Smoking
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 |
|---|---|---|
| CPAP treatmentSubjects allocated to this arm will receive continuous positive airway pressure (CPAP) | Device | CPAP treatment |
| Hygienic and dietary adviceSubjects allocated to this arm will receive hygienic and dietary counselling | Other | Conservative treatment |
Primary outcome
Asthma control questionnaire
Time frame: 12 months
To evaluate the impact of CPAP treatment on asthma control based on the Asthma control questionnaire (ACQ)
Asthma control test
Time frame: 12 months
To evaluate the impact of CPAP treatment on asthma control based on the Asthma control test (ACT)
6 secondary outcomes
Lung function- forced expiratory volume in the first second (FEV1) in spirometry
Time frame: 12 months
Lung function-forced vital capacity (FVC) in spriometry
Time frame: 12 months
Prevalence of OSA in severe uncontrolled asthma
Time frame: Baseline
Inflammatory profile
Time frame: Baseline, 6 and 12 months
Quality of life (Abbreviated Asthma Quality of life Questionnaire- mini-AQLQ questionnaire)
Time frame: 12 months
Exacerbations
Time frame: From enrollment to the end of the study at 12 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 21 Sep 2026.
- Individual participant dataSharing planned: Yes. Anonymized IPD will be available upon reasonable request following publication of the study results. Requests will be valuated by the study team and be subject to applicable ethical, legal and data portection requeriments.
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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.
Mireia Dalmases, MD principal investigator
Hospital Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP treatment and Hygienic and dietary advice in people with Obstructive Sleep Apnea and Asthma, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 21 Sep 2026. 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 Spain. 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?
Contact Mireia Dalmases, MD (+34932275746, mdalmase@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma control questionnaire (time frame: 12 months). The study lists 2 primary outcomes in all. 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 21 Sep 2026.