Obstructive Sleep Apnea and Genes Expression (HIP)

Sleep Apnea: Interface Between Basic and Clinical Research

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.

Study Overview

• Status: Unknown
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Procedure: Continuous Positive Airway Pressure (CPAP)

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 Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 04020-060
      • Recruiting
      • AFIP - Instituto do Sono (Sleep Institute)
      • Contact: Juliana C Perry, PhD; Phone Number: 55-11-8636-9979; Email: julianaciniperry@gmail.com
      • Contact: Silverio A Garbuio, Master; Phone Number: 55-11-8611-9251; Email: silverio.garbuio@gmail.com
      • Sub-Investigator: Juliana C Perry, PhD
      • Principal Investigator: Lia Rita A Bittencourt, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CPAP; CPAP - Continuous Positive Airway Pressure, gold standard treatment to Obstructive Sleep Apnea	Procedure: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gene expression	A total of 84 genes are evaluated using the Hypoxia Signaling Pathway PCR Array (SA Biosciences, EUA), C-reactive protein (CRP), and biochemical parameters	6 months after the basal evaluation

Collaborators and Investigators

• Sponsor: Associacao Fundo de Incentivo a Psicofarmcologia
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo; Conselho Nacional de Desenvolvimento Científico e Tecnológico
• Investigators: Principal Investigator: Juliana C Perry, PhD, Federal University of São Paulo; Study Director: Lia Rita A Bittencourt, MD, PhD, Associacao Fundo de Incentivo a Psicofarmacologia

Publications and helpful links

Helpful Links

• Hypoxia Signaling Pathway PCR Array (SA Biosciences, EUA)
• American Academy of Sleep Medicine

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): July 1, 2011
• Study Completion (Anticipated): October 1, 2011

Study Registration Dates

• First Submitted: July 7, 2011
• First Submitted That Met QC Criteria: July 11, 2011
• First Posted (Estimate): July 12, 2011

Study Record Updates

• Last Update Posted (Estimate): July 12, 2011
• Last Update Submitted That Met QC Criteria: July 11, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: sleep; Obstructive Sleep Apnea; CPAP; hypoxia; translational science; gene expression
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 0985/08

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No