Obstructive Sleep Apnea and Genes Expression

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-10-31

Brief Summary

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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.

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Detailed Description

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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

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Obstructive Sleep Apnea

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Investigators

Study Groups

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CPAP

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

Group Type EXPERIMENTAL

Continuous Positive Airway Pressure (CPAP)

Intervention Type PROCEDURE

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

Interventions

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Continuous Positive Airway Pressure (CPAP)

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes