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

April 17, 2018 updated by: Naomi Kondo Nakagawa, University of Sao Paulo

Nasal and Oronasal Mask During CPAP Titration on CPAP Level, Apnoea-hypopnoea Index, Airway Defense Biomarkers and Systemic Expression of mi RNA in Patients With Severe Obstructive Sleep Apnea and no History of Nasal Obstruction

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05403-900
        • Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
    • Sao Paulo
      • São Paulo, Sao Paulo, Brazil, 01246-903
        • Faculdade de Medicina da Universidade de Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Nasal CPAP during titration
Group nasal mask: use of CPAP for one night whit wash out of two weeks
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
Other Names:
  • Nasal mask
Experimental: Oronasal CPAP during titration
Group oronasal mask: use of CPAP for one night with wash out of two weeks.
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
Other Names:
  • Oronasal mask

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in Apnea-Hypopnea Index
Time Frame: Baseline (Time 0), after CPAP titration with nasal and oronasal mask (one night with wash out of two weeks) and after 30-day period of treatment
A full-night diagnostic polysomnography (PSG) was performed in each subject to determine the stages of sleep, an electroencephalogram, electro-oculogram and electromyogram of the submentalis muscle were obtained. Peripheric blood oxygenation was recorded with the use of a finger pulse oximeter. Thoracoabdominal excursions were measured qualitatively using respiratory effort sensors placed over the ribcage and abdomen. Snoring was detected with a vibration snore sensor and body posture with a body position sensor. Subjects used a molded single-piece translucent silicone rubber mask. During titration, a mask with CPAP was added and the procedure was performed according to AASM guidelines.
Baseline (Time 0), after CPAP titration with nasal and oronasal mask (one night with wash out of two weeks) and after 30-day period of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Airway inflammation by exhaled breath condensate pH
Time Frame: Participants will be assessed at baseline (Time 0), nasal CPAP, oronasal CPAP and after 30-day CPAP treatment (30 days)
The EBC sample was collected over 15 min of quiet and normal breathings (regular tidal volumes and respiratory rate) through a mouthpiece that was connected to a collector device. Participants were asked to avoid to eat green vegetables and canned or embebbed food the 24 hours before measurements. Ph measurements were performed after dearation with ultrapure argon gas (99.9%).
Participants will be assessed at baseline (Time 0), nasal CPAP, oronasal CPAP and after 30-day CPAP treatment (30 days)
Nasal mucociliary clearance by saccharine transit time
Time Frame: Participants were assessed at at baseline (Time 0), nasal CPAP, oronasal CPAP and after 30-day CPAP treatment (30 days)
We evaluate the nasal MCC by measuring nasal saccharine transport time (STT). The subject was asked to avoid alcohol, tea and coffee for 6 hours and to eat or drink nothing for 2 hours before the measurements. The STT assessment is performed in a quiet room at a temperature of 21-22ºC and relative humidity of 63-71%. Subjects sat in a chair and are asked to maintain regular breathing, to avoid deep breathing, coughing, sneezing, sniffing or talking during STT measurements. Twenty-five µg saccharin particles are deposited 2 cm from the anterior end of the non-obstructed nostril and the timer is stopped at the first perception of sweet taste. The maximum delay between the deposition and perception is set at 60 minutes for non-detection.
Participants were assessed at at baseline (Time 0), nasal CPAP, oronasal CPAP and after 30-day CPAP treatment (30 days)
Nasal inflammation by pH, citology and cytokines and adhesion molecules in nasal lavage
Time Frame: Participants were assessed at baseline (Time 0) and after nasal titration, oronasal titration and CPAP treatment (30 days)
TNF-α, IL-1beta, IL-6, IL-8, IL-10, IL-13, IL-17, MPO, MIPs, MMPs and cardiovascular panels (multiplex bead assay, Millipore, USA) using ELISA in nasal lavage.
Participants were assessed at baseline (Time 0) and after nasal titration, oronasal titration and CPAP treatment (30 days)
Sleep quality by Pittsburg Questionnaire
Time Frame: Participants will be assessed at at baseline (Time 0) and after CPAP treatment (30 days)
It is a questionnaire to assess the quality of sleep (basically 7 components) - cut off >5: the worst quality
Participants will be assessed at at baseline (Time 0) and after CPAP treatment (30 days)
Upper airways symptoms by SNOT20 questionnaire
Time Frame: Participants will be assessed at at baseline (Time 0) and CPAP treatment (30 days)
This is a questionnaire that aims to assess quality of life of patients with chronic upper airways symptoms
Participants will be assessed at at baseline (Time 0) and CPAP treatment (30 days)
Excessive sonolence during daytime by Epworth Sleepiness Scale
Time Frame: Participants will be assessed at at baseline (Time 0) and CPAP treatment (30 days)
This is a questionnaire about daytime sleepiness with 8 questions. Cut-off >10: yes
Participants will be assessed at at baseline (Time 0) and CPAP treatment (30 days)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cytokines, adhesion molecules and miRNAs in serum
Time Frame: Participants will be assessed at at baseline (Time 0) and CPAP treatment (30 days)
TNF-α, IL-1beta, IL-6, IL-8, IL-10, IL-13, IL-17, MPO, MIPs, MMPs and cardiovascular panels (multiplex bead assay, Millipore, USA) using ELISA in nasal lavage. For miRNA PCR analysis, RNA was extracted from the blood sample, quantified and analysed.
Participants will be assessed at at baseline (Time 0) and CPAP treatment (30 days)
adherence to CPAP
Time Frame: 1 and 12 months
we assessed the time use by CPAP device card
1 and 12 months
CPAP level
Time Frame: CPAP titration with nasal and oronasal mask (one full night for each mask )
Using two full-nights polysomnography for CPAP titration. To determine the appropriate CPAP level with nasal and oronasal masks
CPAP titration with nasal and oronasal mask (one full night for each mask )
PSG variables
Time Frame: At baseline and after CPAP titration with nasal and oronasal mask (one full night for each)
All variables were provided by the study with PSG according to AASM guidelines
At baseline and after CPAP titration with nasal and oronasal mask (one full night for each)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Sao Paulo

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Juliana A Nascimento, PhD, Faculdade de Medicina da Universidade de Sao Paulo
  • Study Director: Naomi K Nakagawa, PhD, Faculdade de Medicina da Universidade de Sao Paulo
  • Study Chair: Geraldo Lorenzi-Filho, PhD, Heart Institute - Hospital Das Clinicas Da Faculdade de Medicina Da Universidade de São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 24, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CEP 102/13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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