Sleep Apnea, ObstructiveATMOSNCT04128930
Ambulatory CPAP Titration in Moderate Obstructive Sleep Apnea
A study testing PAP titration at home in people with Sleep Apnea, Obstructive, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
The aim of this trial is to compare two different ways of CPAP titration: CAP titration with fixed pressure vs. auto-titrating CPAP. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- PAP titration at home
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Oct 2019to 31 Dec 2021
- 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
- moderate OSA (obstructive AHI 15-30/u on initial PSG)
Who cannot join
- Presence of hypoventilation
- Presence of central sleep apnea (central AHI ≥ 15)
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this trial is to compare two different ways of CPAP titration:
CAP titration with fixed pressure vs. auto-titrating CPAP.
Read the detailed description
Continuous positive airway pressure (CPAP) for the treatment of moderate obstructive sleep apnea (OSA) is only reimbursed in Belgium after in-laboratory overnight titration. Nevertheless, in a recent clinical practice guideline of the AASM, it is recommended that PAP therapy can be initiated using either in-laboratory titration or auto-titrating CPAP (APAP) at home in OSA patients without significant comorbidities. Indeed, several studies evaluated the impact of titration with APAP at home in these patients and showed that the outcome is comparable with in-hospital titration. Up to now, evidence for home titration with fixed CPAP (and follow-up via telemonitoring) is very limited. The use of sleep laboratory space is costly and limits access for diagnostic studies. This study aims to evaluate whether CPAP titration at home with fixed CPAP produces outcomes equal to those following APAP titration.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- PAP titration at home
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAP titration at homeDevice
Fixed CPAP or APAP titration at home
| Study group | Role | What they receive |
|---|---|---|
| Fixed CPAP titration at home | Experimental | Patients will start CPAP treatment with a pressure that is calculated by the following formula (predicted pressure = (0.13 x BMI) + (0.16x neck circumference in cm) + (0.04 x AHI)) with a maximal pressure of 10 cmH2O. After 3 nights and after 7 nights, CPAP data will be remotely evaluated and pressure will be adapted based on the following rules:
* After 3 nights: median obstructive AHI<5/h: decrease pressure with 2 cmH2O; median obstructive AHI>5/h: increase with 2cmH2O
* After 7 nights: median obstructive AHI>5/h of 4 nights after last adaptation: increase with 2 cmH2O Receives: Device: PAP titration at home |
| APAP titration at home | Active comparator | Patients will start CPAP treatment with an auto-adjusting CPAP device with pressure levels between 4 and 12 cmH2O. After 7 nights of titration, the optimal pressure will be determined by analyzing the median of the nightly pressure that included 95% of the periods (percentile 95). CPAP treatment will be continued with this fixed optimal pressure. Receives: Device: PAP titration at home |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPAP adherence
Usage of the device (mean number of hours/day)
Measured: 3 months
Secondary outcomes (10)
Effective pressure level
Optimal pressure of CPAP therapy
Measured: 2 weeks
Residual apnea/hypopnea index
Residual respiratory events during treatment with optimal CPAP pressure during PSG
Measured: 2 weeks
Mask leaks
Objective leaks (L/min) during CPAP treatment
Measured: 2 weeks
Proportion of good titration
Number of patients with residual AHI < 10 (objectivated with PSG)
Measured: 2 weeks
Residual device AHI
Residual AHI as determined from device data
Measured: 3 months
Epworth Sleepiness Scale
Daytime sleepiness (range: 0-24 - higher score means worse outcome)
Measured: 3 months
Blood pressure
Blood pressure measurement
Measured: 3 months
Pittsburgh Sleep Quality Index (PSQI)
Sleep quality (range: 0-21 - higher score means worse outcome)
Measured: 3 months
36-Item Short Form Health Survey
Quality of life (range: 0-100 - higher score means better outcome)
Measured: 3 months
Hospital contacts
Number of contacts with the hospital
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start14 Oct 2019
- Primary completion1 Oct 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dries Testelmans, MD, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04128930
- Sponsor's protocol ID
- S62965
- Acronym
- ATMOS
- Status last verified
- Jul 2024
- First submitted
- 14 Oct 2019
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- Ambulatory CPAP Titration in Moderate Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT04128930
- Acronym / sponsor ID
- ATMOS / S62965
- Conditions
- Sleep Apnea, Obstructive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 14 Oct 2019 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 16 Oct 2019 (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 this trial is to compare two different ways of CPAP titration:
CAP titration with fixed pressure vs. auto-titrating CPAP.
Detailed description
Continuous positive airway pressure (CPAP) for the treatment of moderate obstructive sleep apnea (OSA) is only reimbursed in Belgium after in-laboratory overnight titration. Nevertheless, in a recent clinical practice guideline of the AASM, it is recommended that PAP therapy can be initiated using either in-laboratory titration or auto-titrating CPAP (APAP) at home in OSA patients without significant comorbidities. Indeed, several studies evaluated the impact of titration with APAP at home in these patients and showed that the outcome is comparable with in-hospital titration. Up to now, evidence for home titration with fixed CPAP (and follow-up via telemonitoring) is very limited. The use of sleep laboratory space is costly and limits access for diagnostic studies. This study aims to evaluate whether CPAP titration at home with fixed CPAP produces outcomes equal to those following APAP titration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fixed CPAP titration at home | Experimental | Device: PAP titration at homePatients will start CPAP treatment with a pressure that is calculated by the following formula (predicted pressure = (0.13 x BMI) + (0.16x neck circumference in cm) + (0.04 x AHI)) with a maximal pressure of 10 cmH2O. After 3 nights and after 7 nights, CPAP data will be remotely evaluated and pressure will be adapted based on the following rules: * After 3 nights: median obstructive AHI<5/h: decrease pressure with 2 cmH2O; median obstructive AHI>5/h: increase with 2cmH2O * After 7 nights: median obstructive AHI>5/h of 4 nights after last adaptation: increase with 2 cmH2O |
| APAP titration at home | Active comparator | Device: PAP titration at homePatients will start CPAP treatment with an auto-adjusting CPAP device with pressure levels between 4 and 12 cmH2O. After 7 nights of titration, the optimal pressure will be determined by analyzing the median of the nightly pressure that included 95% of the periods (percentile 95). CPAP treatment will be continued with this fixed optimal pressure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- moderate OSA (obstructive AHI 15-30/u on initial PSG)
Key exclusion criteria (2 listed)
- Presence of hypoventilation
- Presence of central sleep apnea (central AHI ≥ 15)
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 |
|---|---|---|
| PAP titration at homeFixed CPAP or APAP titration at home | Device | APAP titration at home, Fixed CPAP titration at home |
Primary outcome
CPAP adherence
Time frame: 3 months
Usage of the device (mean number of hours/day)
10 secondary outcomes
Effective pressure level
Time frame: 2 weeks
Residual apnea/hypopnea index
Time frame: 2 weeks
Mask leaks
Time frame: 2 weeks
Proportion of good titration
Time frame: 2 weeks
Residual device AHI
Time frame: 3 months
Epworth Sleepiness Scale
Time frame: 3 months
Blood pressure
Time frame: 3 months
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 3 months
36-Item Short Form Health Survey
Time frame: 3 months
Hospital contacts
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Sleep Apnea, Obstructive
Not yet recruitingObservational study
Heart and Brain Blood Flow in Obstructive Sleep Apnea
Obstructive Sleep Apnea (OSA)
RecruitingObservational study
Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
Pediatric Obstructive Sleep Apnea
Not yet recruitingPhase 3
UBT251 Injection Phase Ⅲ Study (OSA-NPAP)
Obstructive Sleep Apnea, Obesity
Not yet recruitingObservational study
Orthognathic Surgery and Obstructive Sleep Apnea Assessed by Mandibular Jaw Movement Monitoring (SUNRISE-ORTHO)
Obstructive Sleep Apnea, Sleep Apnea, Obstructive
RecruitingObservational study
Functional Capacity in Obstructive Sleep Apnea
Obstructive Sleep Apnea
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.
Dries Testelmans, MD, PhD principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAP titration at home in people with Sleep Apnea, Obstructive, 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 1 inclusion and 2 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
CPAP adherence (time frame: 3 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 3 Jul 2024.