Comparison of Two Telemonitoring Auto-titrating Modalities in OSA Patients

Not Applicable

Completed

• Conditions: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Disordered Breathing; Sleep Disorders, Intrinsic; Sleep Wake Disorders; Apnea; Respiration; Sleep Disorder; Respiratory Tract Disease
• Interventions: Device: EZ START Titration; Device: APAP Titration

• Registration Number: NCT03734341
• Lead Sponsor: Basque Health Service

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 Timeline

• Study Start: 2018-04-01
• Primary Completion: 2018-09-01
• Study First Submitted: 2018-11-06
• Study First Submitted QC: 2018-11-06
• Study First Posted: 2018-11-07
• Status Verified: 2019-01
• Study Completion: 2019-01-07
• Last Update Submitted: 2019-01-07
• Last Update Posted: 2019-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
EZ START Titration	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).
EZ START Titration	APAP 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).
APAP Titration	EZ START 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).
APAP Titration	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).

Primary Outcome Measures

Name	Time	Method
Titration pressure	14-day maximum period	Titration pressure in any modality

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital Universitario Araba; 🇪🇸 Vitoria-Gasteiz, Alava, Spain