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Obstructive Sleep Apnea of NewbornNCT02274194

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

A study testing Nasal CPAP and Oronasal CPAP in people with Obstructive Sleep Apnea of Newborn, run by University of Sao Paulo at 2 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Obstructive Sleep Apnea of Newborn
What is being tested?
Nasal CPAP and Oronasal CPAP
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
2 sitesBrazil
Study dates
Apr 2013to Mar 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Brazil2 sites

  • Faculdade de Medicina da Universidade de Sao Paulo

    São Paulo, São Paulo, 01246-903

  • Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

    São Paulo, 05403-900

Other trials in Brazil

About this study

Official title: 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.

Read the 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.

Being tested
Nasal CPAP, Oronasal CPAP
Keywords
obstructive sleep apnoea, nasal mask, oronasal mask, breathing route, CPAP
Medical subject headings
Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nasal CPAPDevice

    Also called Nasal mask

    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 CPAPDevice

    Also called Oronasal mask

    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

Study groups in NCT02274194
Study groupRoleWhat they receive
Nasal CPAP during titrationActive comparatorGroup nasal mask: use of CPAP for one night whit wash out of two weeks
Receives: Device: Nasal CPAP
Oronasal CPAP during titrationExperimentalGroup oronasal mask: use of CPAP for one night with wash out of two weeks.
Receives: Device: Oronasal CPAP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in Apnea-Hypopnea Index

    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.

    Measured: 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 outcomes (6)

  1. Airway inflammation by exhaled breath condensate pH

    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%).

    Measured: Participants will be assessed at baseline (Time 0), nasal CPAP, oronasal CPAP and after 30-day CPAP treatment (30 days)

  2. Nasal mucociliary clearance by saccharine transit time

    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.

    Measured: Participants were assessed at at baseline (Time 0), nasal CPAP, oronasal CPAP and after 30-day CPAP treatment (30 days)

  3. Nasal inflammation by pH, citology and cytokines and adhesion molecules in nasal lavage

    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.

    Measured: Participants were assessed at baseline (Time 0) and after nasal titration, oronasal titration and CPAP treatment (30 days)

  4. Sleep quality by Pittsburg Questionnaire

    It is a questionnaire to assess the quality of sleep (basically 7 components) - cut off >5: the worst quality

    Measured: Participants will be assessed at at baseline (Time 0) and after CPAP treatment (30 days)

  5. Upper airways symptoms by SNOT20 questionnaire

    This is a questionnaire that aims to assess quality of life of patients with chronic upper airways symptoms

    Measured: Participants will be assessed at at baseline (Time 0) and CPAP treatment (30 days)

  6. Excessive sonolence during daytime by Epworth Sleepiness Scale

    This is a questionnaire about daytime sleepiness with 8 questions. Cut-off >10: yes

    Measured: Participants will be assessed at at baseline (Time 0) and CPAP treatment (30 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2014 (estimated)
  2. Study startApr 2013
  3. Primary completionDec 2016
  4. Study completionMar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02274194
Sponsor's protocol ID
CEP 102/13
Status last verified
Apr 2018
First submitted
30 Sep 2014
Last updated
19 Apr 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Nasal CPAP and Oronasal CPAP in people with Obstructive Sleep Apnea of Newborn, run by University of Sao Paulo at 2 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02274194.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2018.

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