ApneaNCT03734341
Comparison of Two Telemonitoring Auto-titrating Modalities in OSA Patients
A study testing EZ START Titration and APAP Titration in people with Apnea and Sleep Apnea Syndromes, run by Basque Health Service at 1 site in Spain.
Trial summary
This study compares the titration pressures achieved through two auto-titrating modalities, a new incremental fixed pressure mode versus routine auto-adjusting pressure mode, in CPAP-naïve obstructive sleep apnea patients. The aim of the study is to verify that this new modality achieves a lower titration pressure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Apnea, Sleep Apnea Syndromes, Sleep Apnea, Obstructive
- What is being tested?
- EZ START Titration and APAP Titration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2018to 7 Jan 2019
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80
- OSA diagnosis
- CPAP therapy indication
Who cannot join
- Previous CPAP therapy
- Severe COPD
- Respiratory insufficiency
- Obesity-hypoventilation syndrome
- Cardiac failure
- Recent cerebrovascular disease
Show all 12Show fewer
- Central apnea, Cheyne Stokes or similar
- Important nasal insufficiency or malformation
- Previous pharyngeal surgery
- Shift work
- Psychosocial disability
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Telemonitoring Crossover Study Comparing a New Incremental Fixed Pressure Titration Modality Versus Auto-adjustable Titration for CPAP-naïve Obstructive Sleep Apnea Patients
This study compares the titration pressures achieved through two auto-titrating modalities, a new incremental fixed pressure mode versus routine auto-adjusting pressure mode, in CPAP-naïve obstructive sleep apnea patients.
The aim of the study is to verify that this new modality achieves a lower titration pressure.
Read the detailed description
In patients with obstructive sleep apnea (OSA) on CPAP treatment, a CPAP titration test is usually performed to achieve the optimal pressure to maintain upper airway patency, abolish obstructive respiratory events and reduce the occurrence of adverse events. This pressure is called titration pressure.
Until now, we used to perform, after an adaptation period, a single-night outpatient test with an automated device preset on auto-adjusting pressure modality (APAP).
The incremental fixed pressure modality (EZ START) was initially developed to ease patients into having a positive sleep therapy experience from the very beginning. This mode gradually increases air pressure night-by-night until the preset therapeutic pressure is reached. In each good therapy session, the device performs in fixed pressure overnight and we get a real residual apnea-hypopnea index (rAHI).
For this study, we will use the same device (DreamStation auto CPAP, Philips Respironics, Murrysville, PA, USA), a web-based system to telemonitor patient therapy (EncoreAnywhere) and perform for each individual patient the two modalities in a telemonitoring crossover randomized single-blind (patient) way.
- Conditions
- Apnea, Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Sleep Disordered Breathing, Respiration; Sleep Disorder, Respiratory Tract Disease
- Being tested
- EZ START Titration, APAP Titration
- Keywords
- CPAP, Titration, Obstructive Sleep Apnea, Telemonitoring, Telemedicine
- Medical subject headings
- Apnea, Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Respiratory Aspiration, Sleep Wake Disorders, Respiratory Tract Diseases, Sleep Disorders, Intrinsic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EZ START TitrationDevice
Also called DreamStation auto CPAP, Philips Respironics, EncoreAnywhere
The auto CPAP device gradually increases air pressure night-by-night until the preset therapeutic pressure is reached.
Pressure range: from 5 to 14 cmH2O. Ramp: 4cmH2O, 20 minutes. Mask: nasal (if no contraindication).
Titration pressure: fixed pressure that reduces rAHI below 10, mask leak below 10% of the session, time session above 4 hours.
APAP TitrationDevice
Also called DreamStation auto CPAP, Philips Respironics, EncoreAnywhere
The auto CPAP device continuously adjusts the pressure in real time to the minimum pressure needed to maintain upper airway patency at any moment. Pressure range: 5 to 14 cm H2O. Ramp: 4cmH2O, 20 minutes. Mask: nasal (if no contraindication).
Titration pressure: visual analysis pressure that reduces rAHI below 10 during 90% of the session, mask leak below 10% of the session, therapeutic session above 4 hours.
| Study group | Role | What they receive |
|---|---|---|
| EZ START Titration | Experimental | CPAP titration test performed with an auto CPAP device preset on incremental fixed pressure modality. If the titration pressure is achieved (in a 14-day maximum period) the device will be immediately and remotely preset in CPAP modality with EZ START pressure (if any) for a 14-day period to check the titration pressure performance in a short-time period.
Afterwards, the device will be remotely preset on the next modality: auto-adjusting pressure (no wash-out period). Receives: Device: EZ START Titration; Device: APAP Titration |
| APAP Titration | Active comparator | CPAP titration test performed with an auto CPAP device preset on auto-adjusting pressure modality. If the titration pressure is achieved (in a 14-day maximum period) the device will be immediately and remotely preset in CPAP modality with APAP pressure (if any) for a 14-day period to check the titration pressure performance in a short-time period.
Afterwards, the device will be remotely preset on the next modality: incremental fixed pressure (no wash-out period). Receives: Device: EZ START Titration; Device: APAP Titration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Titration pressure
Titration pressure in any modality
Measured: 14-day maximum period
Secondary outcomes (2)
CPAP Adherence
Adjusted adherence: days of use (%) * hours of use (mean)
Measured: 14-day period
CPAP Efficacy
Residual AHI (mean) in the period
Measured: 14-day period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start1 Apr 2018
- Primary completion1 Sep 2018
- Study completion7 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ApneaStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Basque Health Service
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mikel Azpiazu, Basque Health Service
- Investigators
- Mikel Azpiazu, MD, Principal investigator, Basque Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734341
- Sponsor's protocol ID
- 2017-37
- Status last verified
- Jan 2019
- First submitted
- 6 Nov 2018
- Last updated
- 9 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kushida CA, Chediak A, Berry RB, Brown LK, Gozal D, Iber C, Parthasarathy S, Quan SF, Rowley JA; Positive Airway Pressure Titration Task Force; American Academy of Sleep Medicine. Clinical guidelines for the manual titration of positive airway pressure in patients with obstructive sleep apnea. J Clin Sleep Med. 2008 Apr 15;4(2):157-71.
PubMed 18468315Masa JF, Jimenez A, Duran J, Capote F, Monasterio C, Mayos M, Teran J, Hernandez L, Barbe F, Maimo A, Rubio M, Montserrat JM. Alternative methods of titrating continuous positive airway pressure: a large multicenter study. Am J Respir Crit Care Med. 2004 Dec 1;170(11):1218-24. doi: 10.1164/rccm.200312-1787OC. Epub 2004 Jul 28.
PubMed 15282204McArdle N, Singh B, Murphy M, Gain KR, Maguire C, Mutch S, Hillman DR. Continuous positive airway pressure titration for obstructive sleep apnoea: automatic versus manual titration. Thorax. 2010 Jul;65(7):606-11. doi: 10.1136/thx.2009.116756.
PubMed 20627917Ahmed O, Parthasarathy S. APAP and Alternative Titration Methods. Sleep Med Clin. 2010 Sep 1;5(3):361-368. doi: 10.1016/j.jsmc.2010.05.010.
PubMed 20806054
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Telemonitoring Crossover Study Comparing a New Incremental Fixed Pressure Titration Modality Versus Auto-adjustable Titration for CPAP-naïve Obstructive Sleep Apnea Patients
- ClinicalTrials.gov ID
- NCT03734341
- Acronym / sponsor ID
- 2017-37
- Conditions
- Apnea, Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Sleep Disordered Breathing, Respiration; Sleep Disorder, Respiratory Tract Disease
- Keywords
- CPAP, Titration, Obstructive Sleep Apnea, Telemonitoring, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Basque Health ServiceOther government
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 7 Jan 2019 (actual)
- First posted
- 7 Nov 2018 (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.
This study compares the titration pressures achieved through two auto-titrating modalities, a new incremental fixed pressure mode versus routine auto-adjusting pressure mode, in CPAP-naïve obstructive sleep apnea patients.
The aim of the study is to verify that this new modality achieves a lower titration pressure.
Detailed description
In patients with obstructive sleep apnea (OSA) on CPAP treatment, a CPAP titration test is usually performed to achieve the optimal pressure to maintain upper airway patency, abolish obstructive respiratory events and reduce the occurrence of adverse events. This pressure is called titration pressure.
Until now, we used to perform, after an adaptation period, a single-night outpatient test with an automated device preset on auto-adjusting pressure modality (APAP).
The incremental fixed pressure modality (EZ START) was initially developed to ease patients into having a positive sleep therapy experience from the very beginning. This mode gradually increases air pressure night-by-night until the preset therapeutic pressure is reached. In each good therapy session, the device performs in fixed pressure overnight and we get a real residual apnea-hypopnea index (rAHI).
For this study, we will use the same device (DreamStation auto CPAP, Philips Respironics, Murrysville, PA, USA), a web-based system to telemonitor patient therapy (EncoreAnywhere) and perform for each individual patient the two modalities in a telemonitoring crossover randomized single-blind (patient) way.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EZ START Titration | Experimental | Device: EZ START Titration, Device: APAP TitrationCPAP titration test performed with an auto CPAP device preset on incremental fixed pressure modality. If the titration pressure is achieved (in a 14-day maximum period) the device will be immediately and remotely preset in CPAP modality with EZ START pressure (if any) for a 14-day period to check the titration pressure performance in a short-time period. Afterwards, the device will be remotely preset on the next modality: auto-adjusting pressure (no wash-out period). |
| APAP Titration | Active comparator | Device: EZ START Titration, Device: APAP TitrationCPAP titration test performed with an auto CPAP device preset on auto-adjusting pressure modality. If the titration pressure is achieved (in a 14-day maximum period) the device will be immediately and remotely preset in CPAP modality with APAP pressure (if any) for a 14-day period to check the titration pressure performance in a short-time period. Afterwards, the device will be remotely preset on the next modality: incremental fixed pressure (no wash-out period). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-80
- OSA diagnosis
- CPAP therapy indication
Key exclusion criteria (12 listed)
- Previous CPAP therapy
- Severe COPD
- Respiratory insufficiency
- Obesity-hypoventilation syndrome
- Cardiac failure
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 |
|---|---|---|
| EZ START TitrationAlso: DreamStation auto CPAP, Philips Respironics, EncoreAnywhereThe auto CPAP device gradually increases air pressure night-by-night until the preset therapeutic pressure is reached. Pressure range: from 5 to 14 cmH2O. Ramp: 4cmH2O, 20 minutes. Mask: nasal (if no contraindication). Titration pressure: fixed pressure that reduces rAHI below 10, mask leak below 10% of the session, time session above 4 hours. | Device | APAP Titration, EZ START Titration |
| APAP TitrationAlso: DreamStation auto CPAP, Philips Respironics, EncoreAnywhereThe auto CPAP device continuously adjusts the pressure in real time to the minimum pressure needed to maintain upper airway patency at any moment. Pressure range: 5 to 14 cm H2O. Ramp: 4cmH2O, 20 minutes. Mask: nasal (if no contraindication). Titration pressure: visual analysis pressure that reduces rAHI below 10 during 90% of the session, mask leak below 10% of the session, therapeutic session above 4 hours. | Device | APAP Titration, EZ START Titration |
Primary outcome
Titration pressure
Time frame: 14-day maximum period
Titration pressure in any modality
2 secondary outcomes
CPAP Adherence
Time frame: 14-day period
CPAP Efficacy
Time frame: 14-day period
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 9 Jan 2019.
- Background: PubMed 18468315Kushida CA, Chediak A, Berry RB, Brown LK, Gozal D, Iber C, Parthasarathy S, Quan SF, Rowley JA; Positive Airway Pressure Titration Task Force; American Academy of Sleep Medicine. Clinical guidelines for the manual titration of positive airway pressure in patients with obstructive sleep apnea. J Clin Sleep Med. 2008 Apr 15;4(2):157-71.
- Background: PubMed 15282204Masa JF, Jimenez A, Duran J, Capote F, Monasterio C, Mayos M, Teran J, Hernandez L, Barbe F, Maimo A, Rubio M, Montserrat JM. Alternative methods of titrating continuous positive airway pressure: a large multicenter study. Am J Respir Crit Care Med. 2004 Dec 1;170(11):1218-24. doi: 10.1164/rccm.200312-1787OC. Epub 2004 Jul 28.
- Background: PubMed 20627917McArdle N, Singh B, Murphy M, Gain KR, Maguire C, Mutch S, Hillman DR. Continuous positive airway pressure titration for obstructive sleep apnoea: automatic versus manual titration. Thorax. 2010 Jul;65(7):606-11. doi: 10.1136/thx.2009.116756.
- Background: PubMed 20806054Ahmed O, Parthasarathy S. APAP and Alternative Titration Methods. Sleep Med Clin. 2010 Sep 1;5(3):361-368. doi: 10.1016/j.jsmc.2010.05.010.
- 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.
Mikel Azpiazu, MD principal investigator
Basque Health Service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EZ START Titration and APAP Titration in people with Apnea and Sleep Apnea Syndromes, run by Basque Health Service 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 3 inclusion and 12 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 9 Jan 2019. 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?
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?
Titration pressure (time frame: 14-day maximum period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03734341, which also lists 4 linked publications.
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 9 Jan 2019.