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Comparison of Two Telemonitoring Auto-titrating Modalities in OSA Patients

Primary Purpose

Apnea, Sleep Apnea Syndromes, Sleep Apnea, Obstructive

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
EZ START Titration
APAP Titration
Sponsored by
Basque Health Service
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Apnea focused on measuring CPAP, Titration, Obstructive Sleep Apnea, Telemonitoring, Telemedicine

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital Universitario Araba

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EZ START Titration

APAP Titration

Arm 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).

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).

Outcomes

Primary Outcome Measures

Titration pressure
Titration pressure in any modality

Secondary Outcome Measures

CPAP Adherence
Adjusted adherence: days of use (%) * hours of use (mean)
CPAP Efficacy
Residual AHI (mean) in the period

Full Information

First Posted
November 6, 2018
Last Updated
January 7, 2019
Sponsor
Basque Health Service
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1. Study Identification

Unique Protocol Identification Number
NCT03734341
Brief Title
Comparison of Two Telemonitoring Auto-titrating Modalities in OSA Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
September 1, 2018 (Actual)
Study Completion Date
January 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Basque Health Service

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apnea, Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Sleep Disordered Breathing, Respiration; Sleep Disorder, Respiratory Tract Disease, Sleep Disorders, Intrinsic, Sleep Wake Disorders
Keywords
CPAP, Titration, Obstructive Sleep Apnea, Telemonitoring, Telemedicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EZ START Titration
Arm Type
Experimental
Arm 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).
Arm Title
APAP Titration
Arm Type
Active Comparator
Arm 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).
Intervention Type
Device
Intervention Name(s)
EZ START Titration
Other Intervention Name(s)
DreamStation auto CPAP, Philips Respironics, EncoreAnywhere
Intervention Description
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
Intervention Name(s)
APAP Titration
Other Intervention Name(s)
DreamStation auto CPAP, Philips Respironics, EncoreAnywhere
Intervention Description
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.
Primary Outcome Measure Information:
Title
Titration pressure
Description
Titration pressure in any modality
Time Frame
14-day maximum period
Secondary Outcome Measure Information:
Title
CPAP Adherence
Description
Adjusted adherence: days of use (%) * hours of use (mean)
Time Frame
14-day period
Title
CPAP Efficacy
Description
Residual AHI (mean) in the period
Time Frame
14-day period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mikel Azpiazu, MD
Organizational Affiliation
Basque Health Service
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Araba
City
Vitoria-Gasteiz
State/Province
Alava
ZIP/Postal Code
01004
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18468315
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.
Results Reference
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PubMed Identifier
15282204
Citation
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.
Results Reference
background
PubMed Identifier
20627917
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.
Results Reference
background
PubMed Identifier
20806054
Citation
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.
Results Reference
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Comparison of Two Telemonitoring Auto-titrating Modalities in OSA Patients

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