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

Obstructive Sleep Apnea of Newborn Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02274194
• Other study ID #: CEP 102/13
• Status: Completed
• Phase: N/A
• First received: September 30, 2014
• Last updated: April 17, 2018
• Start date: April 2013
• Est. completion date: March 2017

Study information

• Verified date: April 2018
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea of Newborn
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Nasal CPAP
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 CPAP
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

Locations

Country	Name	City	State
Brazil	Instituto do Coração - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo	Sao Paulo
Brazil	Faculdade de Medicina da Universidade de Sao Paulo	São Paulo	Sao Paulo

Sponsors (3)

Lead Sponsor	Collaborator
University of Sao Paulo	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cytokines, adhesion molecules and miRNAs in serum	TNF-a, 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. For miRNA PCR analysis, RNA was extracted from the blood sample, quantified and analysed.	Participants will be assessed at at baseline (Time 0) and CPAP treatment (30 days)
Other	adherence to CPAP	we assessed the time use by CPAP device card	1 and 12 months
Other	CPAP level	Using two full-nights polysomnography for CPAP titration. To determine the appropriate CPAP level with nasal and oronasal masks	CPAP titration with nasal and oronasal mask (one full night for each mask )
Other	PSG variables	All variables were provided by the study with PSG according to AASM guidelines	At baseline and after CPAP titration with nasal and oronasal mask (one full night for each)
Primary	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	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%).	Participants will be assessed at baseline (Time 0), nasal CPAP, oronasal CPAP and after 30-day CPAP treatment (30 days)
Secondary	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.	Participants were assessed at at baseline (Time 0), nasal CPAP, oronasal CPAP and after 30-day CPAP treatment (30 days)
Secondary	Nasal inflammation by pH, citology and cytokines and adhesion molecules in nasal lavage	TNF-a, 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.	Participants were assessed at baseline (Time 0) and after nasal titration, oronasal titration and CPAP treatment (30 days)
Secondary	Sleep quality by Pittsburg Questionnaire	It is a questionnaire to assess the quality of sleep (basically 7 components) - cut off >5: the worst quality	Participants will be assessed at at baseline (Time 0) and after CPAP treatment (30 days)
Secondary	Upper airways symptoms by SNOT20 questionnaire	This is a questionnaire that aims to assess quality of life of patients with chronic upper airways symptoms	Participants will be assessed at at baseline (Time 0) and CPAP treatment (30 days)
Secondary	Excessive sonolence during daytime by Epworth Sleepiness Scale	This is a questionnaire about daytime sleepiness with 8 questions. Cut-off >10: yes	Participants will be assessed at at baseline (Time 0) and CPAP treatment (30 days)