Analysis of the cardiac frequency and oxygenation during sleep in patients with the Obstructive Sleep Apnea Syndrome

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-3jdm6d
• Date of registration: 24/04/2012
• Primary sponsor: Universidade Federal de São Carlos - São Carlos, SP, Brazil
• Public title: Analysis of the cardiac frequency and oxygenation during sleep in patients with the Obstructive Sleep Apnea Syndrome
• Scientific title: Study of autonomic cardiac behavior and oxygen saturation during sleep in patients with the Obstructive Sleep Apnea Syndrome
• Date of first enrolment: 01/01/2011
• Target sample size: 150
• Recruitment status: recruiting
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-3jdm6d/
• Study design: Cross-Sectional trial.

Countries of recruitment

Brazil

Contacts

• Name: Renata Trimer
• Affiliation: Universidade Federal de São Carlos

• Name: Renata Trimer
• Affiliation: Universidade Federal de São Carlos

Key inclusion & exclusion criteria

Inclusion criteria: Individuals of both sexes;
Aged 18-80 years;
With suspicion diagnosis of obstructive sleep apnea;
Who underwent full polysomnography in sleep Institute of San Carlos;
Technical data could be analyzed;
Exclusion criteria: Patients who underwent polysomnography, but whose data are not technically acceptable.

Age minimum: 18Y
Age maximum: 80Y
Gender: -

Health Condition(s) or Problem(s) studied

Obstructive Sleep Apnea
C08.618.085.852.850

Intervention(s)

Will be recruited 150 subjects with suspected obstructive sleep apnea and will be evaluated by clinical interview and the questionnaire of daytime sleepiness Epworth. Participants will undergo a single assessment which will consist of a pulse oximetry and polysomnography during a full night's sleep at the Sleep Institute of San Carlos. Recruitment of participants will be from January 2011 to 2014.

Primary Outcome(s)

Presence of subclasses of individuals according to clinical parameters and in different stages of sleep. Measurements: Analysis of oxygen saturation variability and heart rate variability, combined with the other existing methods for analysis of the severity of obstructive sleep apnea, such as the index apnea / hypopnea per hour of sleep, the time of the saturation oxygen spent below 90% and the oxygen desaturation index per hour of sleep.

Secondary Outcome(s)

Increase in the correlation of the variability of oxygen saturation with the heart rate variability in different degrees of severity of obstructive sleep apnea and were considered mild apnea subjects with apnea / hypopnea index between 5 and 15 events per hour of sleep apnea moderate 16 to 30 events and severe apnea more than 30 events per hour of sleep.

Secondary ID(s)

2570.0.000.135-10

401/2010

Source(s) of Monetary Support

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES) - Brasília, DF, Brazil

Secondary Sponsor(s)

Universidade Federal de São Carlos - São Carlos, SP, Brazil