Comparison of Two Telemonitoring Auto-titrating Modalities in OSA Patients

Basque Health Service

Status: Completed

Conditions: Sleep Apnea Syndromes; Respiration; Sleep Disorder; Apnea; Sleep Disordered Breathing; Sleep Disorders, Intrinsic; Sleep Apnea, Obstructive; Respiratory Tract Disease; Sleep Wake Disorders

Treatments: Device: APAP Titration; Device: EZ START Titration

Study type: Interventional

Funder types: Other

Identifiers

NCT03734341

2017-37

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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50 participants in 2 patient groups

EZ START Titration

Experimental group

Description:

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).

Treatment:

Device: EZ START Titration

Device: APAP Titration

APAP Titration

Active Comparator group

Description:

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).

Treatment:

Device: EZ START Titration

Device: APAP Titration