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

NCT02274194 | Completed DMC

• 1 other identifier: CEP 102/13
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

obstructive sleep apnoea; nasal mask; oronasal mask; breathing route; CPAP

Outcome Measures

Primary Outcomes (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.

  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)

• Airway inflammation by exhaled breath condensate pH

  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

  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

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

• Sleep quality by Pittsburg Questionnaire

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

• Upper airways symptoms by SNOT20 questionnaire

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

Other Outcomes (4)

• Cytokines, adhesion molecules and miRNAs in serum

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

• adherence to CPAP

  1 and 12 months

• CPAP level

  CPAP titration with nasal and oronasal mask (one full night for each mask )

Study Arms (2)

Nasal CPAP during titration

ACTIVE COMPARATOR

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

Device: Nasal CPAP

Oronasal CPAP during titration

EXPERIMENTAL

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

Device: Oronasal CPAP

Interventions

Nasal CPAP 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

Also known as: Nasal mask

Nasal CPAP during titration

Oronasal CPAP 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

Also known as: Oronasal mask

Oronasal CPAP during titration

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (2)

Faculdade de Medicina da Universidade de Sao Paulo

São Paulo, São Paulo, 01246-903, Brazil

Location

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

São Paulo, 05403-900, Brazil

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Juliana A Nascimento, PhD

  Faculdade de Medicina da Universidade de Sao Paulo

  PRINCIPAL INVESTIGATOR

• Naomi K Nakagawa, PhD

  Faculdade de Medicina da Universidade de Sao Paulo

  STUDY DIRECTOR

• Geraldo Lorenzi-Filho, PhD

  Heart Institute - Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Physiotherapy

Study Record Dates

• First Submitted: September 30, 2014
• First Posted: October 24, 2014
• Study Start: April 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: April 19, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)