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

July 7, 2011
July 11, 2011
February 2011
July 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01392339 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Obstructive Sleep Apnea and Genes Expression
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.

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).

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Basic Science
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
Experimental: CPAP
CPAP - Continuous Positive Airway Pressure, gold standard treatment to Obstructive Sleep Apnea
Intervention: Procedure: Continuous Positive Airway Pressure (CPAP)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
35
October 2011
July 2011   (final data collection date for primary outcome measure)

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
Male
30 Years to 60 Years
Yes
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
Brazil
 
NCT01392339
0985/08
Yes
Lia Rita Azeredo Bittencourt, Associacao Fundo de Incentivo a Psicofarmacologia - AFIP
Associacao Fundo de Incentivo a Psicofarmcologia
  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Fundação de Amparo à Pesquisa do Estado de São Paulo
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
Associacao Fundo de Incentivo a Psicofarmcologia
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP