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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2017-03-31

Brief Summary

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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.

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Detailed Description

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After agreement with the written informed consent, 30 volunteers (10 healthy volunteers and 20 patients with severe OSA), male and female, aged \> 21 years were recruited in the Sleep Laboratory of Hospital das Clínicas da Faculdade de Medicina (FMUSP). The volunteers were evaluated at the Sleep Laboratory (Incor) in two phases. First Phase: volunteers were assessed for breathing route awake and asleep (including respiratory events in OSA patients) and were indicated as nasal breathing and oronasal breathing. Second phase for OSA patients: two manual full-night CPAP titration with nasal and oronasal masks in a randomized order, 14 days apart. Data and fluids were analyzed before and after both titration studies comparing both masks including supine and lateral position during asleep and CPAP titration. Third phase for OSA patiens: patients were treated with the best interface found in CPAP titration study during 30 days and patients were assessed for sleep quality, excessive sonolence during the day, airway symptoms, airway defense mechanisms biomarkers (mucociliary clearance, mucus properties, citology, inflammation cytokines and adhesion molecules and others) and serum cytokines and miRNA.

Conditions

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Obstructive Sleep Apnea of Newborn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Nasal CPAP during titration

Group nasal mask: use of CPAP for one night whit wash out of two weeks

Group Type ACTIVE_COMPARATOR

Nasal CPAP

Intervention Type DEVICE

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

Oronasal CPAP during titration

Group oronasal mask: use of CPAP for one night with wash out of two weeks.

Group Type EXPERIMENTAL

Oronasal CPAP

Intervention Type DEVICE

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

Interventions

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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

Intervention Type 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

Intervention Type DEVICE

Other Intervention Names

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Nasal mask Oronasal mask

Eligibility Criteria

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Inclusion Criteria

* \>21 years
* moderate or severe obstructive sleep apnea
* nonsmokers
* ex smokers (cessation \>12 months)

Exclusion Criteria

* infection / acute respiratory inflammation (30 days after to study entry)
* history of fixed nasal obstruction
* nasal or upper airways surgery
* chronic diseases without optimized treatment

Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes