Comparison of Two Telemonitoring Auto-titrating Modalities in OSA Patients
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: EZ START Titration 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). |
Device: EZ START Titration
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.
Other Names:
Device: APAP Titration
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.
Other Names:
|
| Active Comparator: APAP Titration 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). |
Device: EZ START Titration
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.
Other Names:
Device: APAP Titration
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Titration pressure [14-day maximum period]
Titration pressure in any modality
Secondary Outcome Measures
- CPAP Adherence [14-day period]
Adjusted adherence: days of use (%) * hours of use (mean)
- CPAP Efficacy [14-day period]
Residual AHI (mean) in the period
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 18-80
-
OSA diagnosis
-
CPAP therapy indication
Exclusion Criteria:
-
Previous CPAP therapy
-
Severe COPD
-
Respiratory insufficiency
-
Obesity-hypoventilation syndrome
-
Cardiac failure
-
Recent cerebrovascular disease
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Central apnea, Cheyne Stokes or similar
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Important nasal insufficiency or malformation
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Previous pharyngeal surgery
-
Shift work
-
Psychosocial disability
-
Refusal to participate
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Universitario Araba | Vitoria-Gasteiz | Alava | Spain | 01004 |
Sponsors and Collaborators
- Basque Health Service
Investigators
- Principal Investigator: Mikel Azpiazu, MD, Basque Health Service
Study Documents (Full-Text)
None provided.More Information
Publications
- Ahmed O, Parthasarathy S. APAP and Alternative Titration Methods. Sleep Med Clin. 2010 Sep 1;5(3):361-368.
- 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.
- Masa JF, Jiménez A, Durán J, Capote F, Monasterio C, Mayos M, Terán J, Hernández L, Barbé F, Maimó 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. Epub 2004 Jul 28.
- 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.
- 2017-37