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

University of Sao Paulo

Status: Completed

Conditions: Obstructive Sleep Apnea of Newborn

Treatments: Device: Nasal CPAP; Device: Oronasal CPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT02274194

CEP 102/13

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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25 participants in 2 patient groups

Nasal CPAP during titration

Active Comparator group

Description:

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

Treatment:

Device: Nasal CPAP

Oronasal CPAP during titration

Experimental group

Description:

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

Treatment:

Device: Oronasal CPAP