Obstructive Sleep Apnea and Genes Expression

Not Applicable

• Conditions: Obstructive Sleep Apnea
• Interventions: Procedure: Continuous Positive Airway Pressure (CPAP)

• Registration Number: NCT01392339
• Lead Sponsor: Associacao Fundo de Incentivo a Psicofarmcologia

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).

Study Timeline

• Study Start: 2011-02
• Status Verified: 2011-03
• Primary Completion: 2011-07
• Study First Submitted: 2011-07-07
• Study First Submitted QC: 2011-07-11
• Last Update Submitted: 2011-07-11
• Study First Posted: 2011-07-12
• Last Update Posted: 2011-07-12
• Study Completion: 2011-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CPAP	Continuous Positive Airway Pressure (CPAP)	CPAP - Continuous Positive Airway Pressure, gold standard treatment to Obstructive Sleep Apnea

Primary Outcome Measures

Name	Time	Method
Apnea/Hypopnea Index	6 months after the basal evaluation	Polysomnographic date of sleep stages percentages, sleep efficiency, arousals, apnea-hypopnea index, oxyhemoglobin saturation

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

AFIP - Instituto do Sono (Sleep Institute); 🇧🇷 Sao Paulo, SP, Brazil