Central Sleep ApneaNCT02919930
Interface Selection for Adaptive Servo Ventilation
A study testing Switch from oronasal to nasal mask during ASV treatment and Switch from nasal to oronasal mask during ASV treatment in people with Central Sleep Apnea and ASV, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The purpose of this study is to compare the effects of nasal and oronasal interfaces during ASV treatment on sleep efficiency and sleep architecture. Therefore, patients starting treatment with ASV, will be randomized between two groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Sleep Apnea, ASV
- What is being tested?
- Switch from oronasal to nasal mask during ASV treatment and Switch from nasal to oronasal mask during ASV treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2015to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients with central sleep apnea, not responding to treatment with CPAP
- Indication for treatment with ASV
Who cannot join
- Patients < 18 years old
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven, 3000
Dries Testelmans, MD, PhD, 00 32 16 342522, dries.testelmans@uzleuven.be
Bart Vrijsen, MSc, PT
About this study
Official title: Interface Selection for Adaptive Servo Ventilation: A Randomized Controlled Study
The purpose of this study is to compare the effects of nasal and oronasal interfaces during ASV treatment on sleep efficiency and sleep architecture. Therefore, patients starting treatment with ASV, will be randomized between two groups. In the first group, patients will use a nasal interface during the first night and an oronasal interface during the second night. In the second group, patients will use an oronasal mask first and a nasal mask during the second night. The results of this trial will have major impact on future clinical practice as it would deliver prediction rules to choose the correct interface immediately.
- Conditions
- Central Sleep Apnea, ASV
- Being tested
- Switch from oronasal to nasal mask during ASV treatment, Switch from nasal to oronasal mask during ASV treatment
- Medical subject headings
- Sleep Apnea, Central
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Switch from oronasal to nasal mask during ASV treatmentDevice
One night of ASV treatment with oronasal mask followed by one night of ASV treatment with nasal mask.
Switch from nasal to oronasal mask during ASV treatmentDevice
One night of ASV treatment with nasal mask followed by one night of ASV treatment with oronasal mask.
| Study group | Role | What they receive |
|---|---|---|
| Oronasal - Nasal | Other | Patients undergo polysomnography with oronasal mask during the first night and nasal mask during the second night. Receives: Device: Switch from oronasal to nasal mask during ASV treatment |
| Nasal - Oronasal | Other | Patients undergo polysomnography with nasal mask during the first night and oronasal mask during the second night. Receives: Device: Switch from nasal to oronasal mask during ASV treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea/hypopnea index
Effect on respiratory events
Measured: Two nights
Secondary outcomes (4)
Mask comfort VAS
Subjective mask comfort
Measured: Two nights
Device leaks data
Evaluation of leaks (data of ASV device)
Measured: Two nights
Sleep efficiency
polysomnographic evaluation
Measured: Two nights
Sleep architecture
Polysomnographic evaluation of different sleep stages
Measured: Two nights
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2016 (estimated)
- Study startFeb 2015
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02919930
- Sponsor's protocol ID
- S57607
- Status last verified
- Jul 2024
- First submitted
- 30 Jun 2016
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interface Selection for Adaptive Servo Ventilation: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02919930
- Acronym / sponsor ID
- S57607
- Conditions
- Central Sleep Apnea, ASV
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 30 Sep 2016 (estimated)
- 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 purpose of this study is to compare the effects of nasal and oronasal interfaces during ASV treatment on sleep efficiency and sleep architecture. Therefore, patients starting treatment with ASV, will be randomized between two groups. In the first group, patients will use a nasal interface during the first night and an oronasal interface during the second night. In the second group, patients will use an oronasal mask first and a nasal mask during the second night. The results of this trial will have major impact on future clinical practice as it would deliver prediction rules to choose the correct interface immediately.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oronasal - Nasal | Other | Device: Switch from oronasal to nasal mask during ASV treatmentPatients undergo polysomnography with oronasal mask during the first night and nasal mask during the second night. |
| Nasal - Oronasal | Other | Device: Switch from nasal to oronasal mask during ASV treatmentPatients undergo polysomnography with nasal mask during the first night and oronasal mask during the second night. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with central sleep apnea, not responding to treatment with CPAP
- Indication for treatment with ASV
Key exclusion criteria (1 listed)
- Patients < 18 years old
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 |
|---|---|---|
| Switch from oronasal to nasal mask during ASV treatmentOne night of ASV treatment with oronasal mask followed by one night of ASV treatment with nasal mask. | Device | Oronasal - Nasal |
| Switch from nasal to oronasal mask during ASV treatmentOne night of ASV treatment with nasal mask followed by one night of ASV treatment with oronasal mask. | Device | Nasal - Oronasal |
Primary outcome
Apnea/hypopnea index
Time frame: Two nights
Effect on respiratory events
4 secondary outcomes
Mask comfort VAS
Time frame: Two nights
Device leaks data
Time frame: Two nights
Sleep efficiency
Time frame: Two nights
Sleep architecture
Time frame: Two nights
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Switch from oronasal to nasal mask during ASV treatment and Switch from nasal to oronasal mask during ASV treatment in people with Central Sleep Apnea and ASV, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 1 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: status not confirmed, as of the sponsor's last update on 3 Jul 2024. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dries Testelmans, MD, PhD (00 32 16 342522, dries.testelmans@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea/hypopnea index (time frame: Two nights). 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 3 Jul 2024.