Clinical trial NCT02274194: Nasal and Oronasal Mask in Severe OSA Patients With Nasal Free Airflow of Obstruction
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea of Newborn
Keywords: obstructive sleep apnoea
nasal mask
oronasal mask
breathing route
CPAP
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2014-10-24
Enrollment: 25
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Apnea-Hypopnea Index
timeFrame: 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:
measure: Airway inflammation by exhaled breath condensate pH
timeFrame: Participants will be assessed at baseline (Time 0), nasal CPAP, oronasal CPAP and after 30-day CPAP treatment (30 days)
measure: Nasal mucociliary clearance by saccharine transit time
timeFrame: Participants were assessed at at baseline (Time 0), nasal CPAP, oronasal CPAP and after 30-day CPAP treatment (30 days)
measure: Nasal inflammation by pH, citology and cytokines and adhesion molecules in nasal lavage
timeFrame: Participants were assessed at baseline (Time 0) and after nasal titration, oronasal titration and CPAP treatment (30 days)
measure: Sleep quality by Pittsburg Questionnaire
timeFrame: Participants will be assessed at at baseline (Time 0) and after CPAP treatment (30 days)
measure: Upper airways symptoms by SNOT20 questionnaire
timeFrame: Participants will be assessed at at baseline (Time 0) and CPAP treatment (30 days)
measure: Excessive sonolence during daytime by Epworth Sleepiness Scale
timeFrame: Participants will be assessed at at baseline (Time 0) and CPAP treatment (30 days)
Other outcomes:
measure: Cytokines, adhesion molecules and miRNAs in serum
timeFrame: Participants will be assessed at at baseline (Time 0) and CPAP treatment (30 days)
measure: adherence to CPAP
timeFrame: 1 and 12 months
measure: CPAP level
timeFrame: CPAP titration with nasal and oronasal mask (one full night for each mask )
measure: PSG variables
timeFrame: At baseline and after CPAP titration with nasal and oronasal mask (one full night for each)
Locations:
city: São Paulo
country: Brazil
facility: Faculdade de Medicina da Universidade de Sao Paulo
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Study officials:
affiliation: Faculdade de Medicina da Universidade de Sao Paulo
name: Juliana A Nascimento, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculdade de Medicina da Universidade de Sao Paulo
name: Naomi K Nakagawa, PhD
role: STUDY_DIRECTOR
affiliation: Heart Institute - Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
name: Geraldo Lorenzi-Filho, PhD
role: STUDY_CHAIR
References: