Obstructive Sleep Apnea and Genes Expression (HIP)

Associacao Fundo de Incentivo a Psicofarmcologia

Status: Unknown

Conditions: Obstructive Sleep Apnea

Treatments: Procedure: Continuous Positive Airway Pressure (CPAP)

Study type: Interventional

Funder types: Other

Identifiers

NCT01392339

0985/08

Details and patient eligibility

About

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.

Full 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).

Enrollment: 35 estimated patients

Sex: Male

Ages: 30 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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35 participants in 1 patient group

CPAP

Experimental group

Description:

CPAP - Continuous Positive Airway Pressure, gold standard treatment to Obstructive Sleep Apnea

Treatment:

Procedure: Continuous Positive Airway Pressure (CPAP)