Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EZ START Titration | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Titration pressure | Titration pressure in any modality | 14-day maximum period |
| Measure | Description | Time Frame |
|---|---|---|
| CPAP Adherence | Adjusted adherence: days of use (%) * hours of use (mean) | 14-day period |
| CPAP Efficacy | Residual AHI (mean) in the period |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Mikel Azpiazu, MD | Basque Health Service | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Araba | Vitoria-Gasteiz | Alava | 01004 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18468315 | Background | 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. | |
| 15282204 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| APAP Titration | Device | 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. |
|
|
| 14-day period |
| Masa 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. |
| 20627917 | Background | McArdle 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. |
| 20806054 | Background | Ahmed 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. |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012891 | Sleep Apnea Syndromes |
| D020181 | Sleep Apnea, Obstructive |
| D053120 | Respiratory Aspiration |
| D012893 | Sleep Wake Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020920 | Dyssomnias |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D009461 | Neurologic Manifestations |
| D001523 | Mental Disorders |
Not provided
Not provided