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Clinical Trials/NCT03734341
NCT03734341CompletedNot Applicable

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

Basque Health Service2 sites in 1 country50 target enrollmentStarted: April 1, 2018Last updated:
Conditions
Interventions

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

Experimental

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

Experimental

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

Active Comparator

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

Active Comparator

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

Sponsor
Basque Health Service
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Mikel Azpiazu

Principal Investigator

Basque Health Service

Study Sites (2)

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