Comparison of Two Telemonitoring Auto-titrating Modalities in OSA Patients
Condition: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Disordered Breathing; Respiration; Sleep Disorder; Respiratory Tract Disease; Sleep Disorders, Intrinsic; Sleep Wake Disorders
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Respiratory Tract Diseases; Sleep Wake Disorders; Parasomnias; Sleep Disorders, Intrinsic
Study type: Interventional

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.
    

Intervention name(s): EZ START Titration; APAP Titration
Intervention type(s): Device; Device
Intervention description(s): 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.; 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 intervention name(s): DreamStation auto CPAP; Philips Respironics; EncoreAnywhere; DreamStation auto CPAP; Philips Respironics; EncoreAnywhere
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: CPAP; Titration; Obstructive Sleep Apnea; Telemonitoring; Telemedicine