Obstructive Sleep Apnea
Conditions
Keywords
Obstructive Sleep Apnea, CPAP, hypoxia, sleep, translational science, gene expression
Brief 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).
Interventions
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
Sponsors
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Fundação de Amparo à Pesquisa do Estado de São Paulo
Associacao Fundo de Incentivo a Psicofarmcologia
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
MALE
Age
30 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Male subjects aged between 30 and 60 years old * Normal range of laboratory tests complete blood count (CBC), glucose, total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL) and very low-density lipoprotein (LDL), triglycerides * Body Mass Index (BMI) \< 35kg/m2
Exclusion criteria
* Presence of clinical diseases (chronic obstructive pulmonary disease, asthma, interstitial lung diseases, neuromuscular diseases, heart failure, thyroid disease, rheumatologic and psychiatric) and other sleep disorders * Smoking status * Participants who had current or historical treatment with CPAP or any other treatment for OSA * Presence of anatomical obstructive upper airway, tonsil grade III and IV septal deviation and grade III (severe) that may affect the outcome of CPAP * Alcoholism * Use of sleep-inducing medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea/Hypopnea Index | 6 months after the basal evaluation | Polysomnographic date of sleep stages percentages, sleep efficiency, arousals, apnea-hypopnea index, oxyhemoglobin saturation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gene expression | 6 months after the basal evaluation | A total of 84 genes are evaluated using the Hypoxia Signaling Pathway PCR Array (SA Biosciences, EUA), C-reactive protein (CRP), and biochemical parameters |
Countries
Brazil
Contacts
Primary ContactJuliana C Perry, PhD
Backup ContactSilverio A Garbuio, Master
Outcome results
None listed