Clinical trial NCT03734341: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Basque Health Service
Sponsor class: OTHER_GOV
First posted: 2018-11-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Titration pressure
timeFrame: 14-day maximum period
Secondary outcomes:
measure: CPAP Adherence
timeFrame: 14-day period
measure: CPAP Efficacy
timeFrame: 14-day period
Other outcomes:
Locations:
city: Vitoria-Gasteiz
country: Spain
facility: Hospital Universitario Araba
state: Alava
Study officials:
affiliation: Basque Health Service
name: Mikel Azpiazu, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.