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Completed

NCT Number: NCT03734341

Comparison of Two Telemonitoring Auto-titrating Modalities in OSA Patients

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: DreamStation auto CPAP, Philips Respironics, EncoreAnywhere

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.

Other names: DreamStation auto CPAP, Philips Respironics, EncoreAnywhere

Primary outcomes

  1. Titration pressure

    Time frame: 14-day maximum period

    Titration pressure in any modality

Secondary outcomes

  1. CPAP Adherence

    Time frame: 14-day period

    Adjusted adherence: days of use (%) * hours of use (mean)

  2. CPAP Efficacy

    Time frame: 14-day period

    Residual AHI (mean) in the period

Sponsors and collaborators

Lead sponsor

Basque Health Service

Other Gov

Registry information

Official study title

A Telemonitoring Crossover Study Comparing a New Incremental Fixed Pressure Titration Modality Versus Auto-adjustable Titration for CPAP-naïve Obstructive Sleep Apnea Patients

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Nov 7, 2018
Registry last updated
Jan 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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