Apnea, Respiration; Sleep Disorder, Respiratory Tract Disease, Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Sleep Disordered Breathing, Sleep Disorders, Intrinsic, Sleep Wake Disorders
Conditions
Keywords
CPAP, Titration, Obstructive Sleep Apnea, Telemonitoring, Telemedicine
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.
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.
Interventions
DEVICEAPAP 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.
DEVICEEZ 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.
Sponsors
Basque Health Service
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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 * Central apnea, Cheyne Stokes or similar * Important nasal insufficiency or malformation * Previous pharyngeal surgery * Shift work * Psychosocial disability * Refusal to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Titration pressure | 14-day maximum period | Titration pressure in any modality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Spain
Outcome results
None listed