Nasal and Oronasal Mask in Severe OSA Patients With Nasal Free Airflow of Obstruction
Condition: Obstructive Sleep Apnea of Newborn
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

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.
    

Intervention name(s): Nasal CPAP; Oronasal CPAP
Intervention type(s): Device; Device
Intervention description(s): 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; 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 intervention name(s): Nasal mask; Oronasal mask
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: obstructive sleep apnoea; nasal mask; oronasal mask; breathing route; CPAP