Clinical Trials Directory

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UnknownNCT01392339

Obstructive Sleep Apnea and Genes Expression

Sleep Apnea: Interface Between Basic and Clinical Research

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
35 (estimated)
Sponsor
Associacao Fundo de Incentivo a Psicofarmcologia · Academic / Other
Sex
Male
Age
30 Years – 60 Years
Healthy volunteers
Accepted

Summary

Obstructive sleep apnea is a multi-component disease. This study will test the hypotheses that hypoxia per se modulates gene expression in animal model of sleep apnea and these results may be translated with alterations that occur in apneic patients. Thus, we aim to integrate basic and clinical research to shed light on novel candidate genes involved in sleep apnea.

Detailed description

Twenty-four male rats were exposed to chronic intermittent hypoxia (5% O2) or normoxia for 6 wks. Following chronic intermittent hypoxia, a group of 8 rats were removed from the chronic intermittent hypoxia protocol and allowed to normoxic conditions over a period of 2 wks. For the clinical protocol, the AHI measured by overnight polysomnography will be use to select individuals with sleep-related breathing disorders, and controls (30-60 years, Body Mass Index (BMI) \< 35kg/m2). Moreover, the investigators will evaluate the subjective sleep parameters (sleep disorders questionnaire, the Epworth Sleepiness Scale, sleep diaries). After standard CPAP titration, men with severe obstructive sleep apnea will be assigned for the CPAP protocol for future assessment of the influence of 6 months obstructive sleep apnea treatment. A total of 84 genes are evaluated using the Hypoxia Signaling Pathway PCR Array (SA Biosciences, EUA).

Conditions

Interventions

TypeNameDescription
PROCEDUREContinuous Positive Airway Pressure (CPAP)Continuous Positive Airway Pressure (CPAP) is a method of respiratory ventilation used primarily in the treatment of obstructive sleep apnea

Timeline

Start date
2011-02-01
Primary completion
2011-07-01
Completion
2011-10-01
First posted
2011-07-12
Last updated
2011-07-12

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT01392339. Inclusion in this directory is not an endorsement.