Nasal and Oronasal Mask in Severe OSA Patients With Nasal Free Airflow of Obstruction

Summary

The obstructive sleep apnea (OSA) affects between 10% to 25% of the adults. Continuous positive airway pressure (CPAP) is the first choice of treatment in severe OSA. However, the adherence to CPAP varies, and the interface between patient and the CPAP may interfere with adherence, comfort and efficiency as well as in sleep variables. Objectives: (1) to determine if self-reported airflow route (nasal or oronasal airflow) is the same as the route determined in a laboratory analysis in controls (healthy subjects) and severe OSA patients with nasal free airflow of obstruction during asleep and awake, (2) to compare the effects of nasal and oronasal CPAP titration (randomized order of masks, 14 days apart) on apnoea-hypopnoea index, CPAP level, PSG variables - including analysis for body positioning, the airway defense mechanisms (nasal mucociliary clearance, mucus properties, citology and inflammation in nasal lavage fluid) and systemic effects (serum miRNA expression and cytokines), (3) CPAP adherence after 1 month and 12 months.

Conditions

• Obstructive Sleep Apnea of Newborn

Interventions

DEVICE

Nasal CPAP

use of nasal mask to titrate CPAP during a manual full night: if nasal mask is the best interface during titration compared with oronasal mask - patients will go 30-day period of treatment

DEVICE

Oronasal CPAP

use of oronasal mask to titrate CPAP during a manual full night: if oronasal mask is the best interface during titration compared with nasal mask - patients will go 30-day period of treatment

Sponsors & Collaborators

• Fundação de Amparo à Pesquisa do Estado de São Paulo

  collaborator OTHER_GOV

• Conselho Nacional de Desenvolvimento Científico e Tecnológico

  collaborator OTHER_GOV

• University of Sao Paulo

  lead OTHER

Principal Investigators

• Juliana A Nascimento, PhD · Faculdade de Medicina da Universidade de Sao Paulo

• Naomi K Nakagawa, PhD · Faculdade de Medicina da Universidade de Sao Paulo

• Geraldo Lorenzi-Filho, PhD · Heart Institute - Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

21 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-04-30

Primary Completion

2016-12-31

Completion

2017-03-31

Countries

• Brazil

Study Locations