Comparison of Two Telemonitoring Auto-titrating Modalities in OSA Patients

Sleep Apnea, Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03734341
• Other study ID #: 2017-37
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: January 7, 2019

Study information

• Verified date: January 2019
• Source: Basque Health Service
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 7, 2019
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Disease
• Parasomnias
• Respiration; Sleep Disorder
• Respiratory Tract Disease
• Respiratory Tract Diseases
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleep Disordered Breathing
• Sleep Disorders, Intrinsic
• Sleep Wake Disorders

Intervention

Device:
• EZ START Titration
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.
• APAP Titration
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.

Locations

Country	Name	City	State
Spain	Hospital Universitario Araba	Vitoria-Gasteiz	Alava

Sponsors (1)

Lead Sponsor	Collaborator
Basque Health Service

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Ahmed O, Parthasarathy S. APAP and Alternative Titration Methods. Sleep Med Clin. 2010 Sep 1;5(3):361-368. — View Citation

Kushida CA, Chediak A, Berry RB, Brown LK, Gozal D, Iber C, Parthasarathy S, Quan SF, Rowley JA; Positive Airway Pressure Titration Task Force; American Academy of Sleep Medicine. Clinical guidelines for the manual titration of positive airway pressure in patients with obstructive sleep apnea. J Clin Sleep Med. 2008 Apr 15;4(2):157-71. — View Citation

Masa JF, Jiménez A, Durán J, Capote F, Monasterio C, Mayos M, Terán J, Hernández L, Barbé F, Maimó A, Rubio M, Montserrat JM. Alternative methods of titrating continuous positive airway pressure: a large multicenter study. Am J Respir Crit Care Med. 2004 Dec 1;170(11):1218-24. Epub 2004 Jul 28. — View Citation

McArdle N, Singh B, Murphy M, Gain KR, Maguire C, Mutch S, Hillman DR. Continuous positive airway pressure titration for obstructive sleep apnoea: automatic versus manual titration. Thorax. 2010 Jul;65(7):606-11. doi: 10.1136/thx.2009.116756. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Titration pressure	Titration pressure in any modality	14-day maximum period
Secondary	CPAP Adherence	Adjusted adherence: days of use (%) * hours of use (mean)	14-day period
Secondary	CPAP Efficacy	Residual AHI (mean) in the period	14-day period