Obstructive Sleep Apnea and Genes Expression (HIP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Associacao Fundo de Incentivo a Psicofarmcologia.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
Associacao Fundo de Incentivo a Psicofarmcologia
ClinicalTrials.gov Identifier:
NCT01392339
First received: July 7, 2011
Last updated: July 11, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention
Obstructive Sleep Apnea
Procedure: Continuous Positive Airway Pressure (CPAP)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
Official Title: Sleep Apnea: Interface Between Basic and Clinical Research

Resource links provided by NLM:


Further study details as provided by Associacao Fundo de Incentivo a Psicofarmcologia:

Primary Outcome Measures:
  • Apnea/Hypopnea Index [ Time Frame: 6 months after the basal evaluation ] [ Designated as safety issue: Yes ]
    Polysomnographic date of sleep stages percentages, sleep efficiency, arousals, apnea-hypopnea index, oxyhemoglobin saturation


Secondary Outcome Measures:
  • Gene expression [ Time Frame: 6 months after the basal evaluation ] [ Designated as safety issue: Yes ]
    A total of 84 genes are evaluated using the Hypoxia Signaling Pathway PCR Array (SA Biosciences, EUA), C-reactive protein (CRP), and biochemical parameters


Estimated Enrollment: 35
Study Start Date: February 2011
Estimated Study Completion Date: October 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01392339

Contacts
Contact: Juliana C Perry, PhD 55-11-8636-9979 julianaciniperry@gmail.com
Contact: Silverio A Garbuio, Master 55-11-8611-9251 silverio.garbuio@gmail.com

Locations
Brazil
AFIP - Instituto do Sono (Sleep Institute) Recruiting
Sao Paulo, SP, Brazil, 04020-060
Contact: Juliana C Perry, PhD    55-11-8636-9979    julianaciniperry@gmail.com   
Contact: Silverio A Garbuio, Master    55-11-8611-9251    silverio.garbuio@gmail.com   
Sub-Investigator: Juliana C Perry, PhD         
Principal Investigator: Lia Rita A Bittencourt, MD, PhD         
Sponsors and Collaborators
Associacao Fundo de Incentivo a Psicofarmcologia
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Fundação de Amparo à Pesquisa do Estado de São Paulo
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
  More Information

Additional Information:
No publications provided

Responsible Party: Lia Rita Azeredo Bittencourt, Associacao Fundo de Incentivo a Psicofarmacologia - AFIP
ClinicalTrials.gov Identifier: NCT01392339     History of Changes
Other Study ID Numbers: 0985/08
Study First Received: July 7, 2011
Last Updated: July 11, 2011
Health Authority: Brazil: Ethics Committee

Keywords provided by Associacao Fundo de Incentivo a Psicofarmcologia:
Obstructive Sleep Apnea
CPAP
hypoxia
sleep
translational science
gene expression

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on August 19, 2014