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Obstructive Sleep Apnea and Genes Expression (HIP)

Primary Purpose

Obstructive Sleep Apnea

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Continuous Positive Airway Pressure (CPAP)
Sponsored by
Associacao Fundo de Incentivo a Psicofarmcologia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obstructive Sleep Apnea focused on measuring Obstructive Sleep Apnea, CPAP, hypoxia, sleep, translational science, gene expression

Eligibility Criteria

30 Years - 60 Years (Adult)MaleAccepts 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

Sites / Locations

  • AFIP - Instituto do Sono (Sleep Institute)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CPAP

Arm Description

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

Outcomes

Primary Outcome Measures

Apnea/Hypopnea Index
Polysomnographic date of sleep stages percentages, sleep efficiency, arousals, apnea-hypopnea index, oxyhemoglobin saturation

Secondary Outcome Measures

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

Full Information

First Posted
July 7, 2011
Last Updated
July 11, 2011
Sponsor
Associacao Fundo de Incentivo a Psicofarmcologia
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01392339
Brief Title
Obstructive Sleep Apnea and Genes Expression
Acronym
HIP
Official Title
Sleep Apnea: Interface Between Basic and Clinical Research
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
February 2011 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
October 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Associacao Fundo de Incentivo a Psicofarmcologia
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Obstructive Sleep Apnea, CPAP, hypoxia, sleep, translational science, gene expression

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CPAP
Arm Type
Experimental
Arm Description
CPAP - Continuous Positive Airway Pressure, gold standard treatment to Obstructive Sleep Apnea
Intervention Type
Procedure
Intervention Name(s)
Continuous Positive Airway Pressure (CPAP)
Intervention Description
Continuous Positive Airway Pressure (CPAP) is a method of respiratory ventilation used primarily in the treatment of obstructive sleep apnea
Primary Outcome Measure Information:
Title
Apnea/Hypopnea Index
Description
Polysomnographic date of sleep stages percentages, sleep efficiency, arousals, apnea-hypopnea index, oxyhemoglobin saturation
Time Frame
6 months after the basal evaluation
Secondary Outcome Measure Information:
Title
Gene expression
Description
A total of 84 genes are evaluated using the Hypoxia Signaling Pathway PCR Array (SA Biosciences, EUA), C-reactive protein (CRP), and biochemical parameters
Time Frame
6 months after the basal evaluation

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Juliana C Perry, PhD
Phone
55-11-8636-9979
Email
julianaciniperry@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Silverio A Garbuio, Master
Phone
55-11-8611-9251
Email
silverio.garbuio@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juliana C Perry, PhD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lia Rita A Bittencourt, MD, PhD
Organizational Affiliation
Associacao Fundo de Incentivo a Psicofarmacologia
Official's Role
Study Director
Facility Information:
Facility Name
AFIP - Instituto do Sono (Sleep Institute)
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04020-060
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juliana C Perry, PhD
Phone
55-11-8636-9979
Email
julianaciniperry@gmail.com
First Name & Middle Initial & Last Name & Degree
Silverio A Garbuio, Master
Phone
55-11-8611-9251
Email
silverio.garbuio@gmail.com
First Name & Middle Initial & Last Name & Degree
Juliana C Perry, PhD
First Name & Middle Initial & Last Name & Degree
Lia Rita A Bittencourt, MD, PhD

12. IPD Sharing Statement

Links:
URL
http://www.sabiosciences.com/
Description
Hypoxia Signaling Pathway PCR Array (SA Biosciences, EUA)
URL
http://www.aasmnet.org/
Description
American Academy of Sleep Medicine

Learn more about this trial

Obstructive Sleep Apnea and Genes Expression

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