A Telemonitoring Crossover Study Comparing a New Incremental Fixed Pressure Titration Modality Versus Auto-adjustable Titration for CPAP-naïve Obstructive Sleep Apnea Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Titration pressure
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
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).
Intervention: EZ START Titration (Device)
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).
Intervention: APAP Titration (Device)
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).
Intervention: EZ START Titration (Device)
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).
Intervention: APAP Titration (Device)
Outcomes
Primary Outcomes
Titration pressure
Time Frame: 14-day maximum period
Titration pressure in any modality
Secondary Outcomes
- CPAP Efficacy(14-day period)
- CPAP Adherence(14-day period)
Investigators
Mikel Azpiazu
Principal Investigator
Basque Health Service