Comparison of Two Telemonitoring Auto-titrating Modalities in OSA Patients

NCT ID: NCT03734341

Last Updated: 2019-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2019-01-07

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

EZ START Titration

Intervention Type: 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.

APAP Titration

Intervention Type: 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.

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).

Group Type: ACTIVE_COMPARATOR

EZ START Titration

Intervention Type: 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.

APAP Titration

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Other Intervention Names

DreamStation auto CPAP; Philips Respironics; EncoreAnywhere; DreamStation auto CPAP; Philips Respironics; EncoreAnywhere

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Basque Health Service

OTHER_GOV

Sponsor Role: lead

Responsible Party

Mikel Azpiazu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mikel Azpiazu, MD

Role: PRINCIPAL_INVESTIGATOR

Basque Health Service

Locations

Hospital Universitario Araba

Vitoria-Gasteiz, Alava, Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 18468315 (View on PubMed)

Masa JF, Jimenez A, Duran J, Capote F, Monasterio C, Mayos M, Teran J, Hernandez L, Barbe F, Maimo 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. doi: 10.1164/rccm.200312-1787OC. Epub 2004 Jul 28.

Reference Type: BACKGROUND

PMID: 15282204 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20627917 (View on PubMed)

Ahmed O, Parthasarathy S. APAP and Alternative Titration Methods. Sleep Med Clin. 2010 Sep 1;5(3):361-368. doi: 10.1016/j.jsmc.2010.05.010.

Reference Type: BACKGROUND

PMID: 20806054 (View on PubMed)

Other Identifiers

2017-37

Identifier Type: -

Identifier Source: org_study_id