Clinical trial NCT01392339: Obstructive Sleep Apnea and Genes Expression
Official title: Sleep Apnea: Interface Between Basic and Clinical Research
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive Sleep Apnea
CPAP
hypoxia
sleep
translational science
gene expression
Lead sponsor: Associacao Fundo de Incentivo a Psicofarmcologia
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2011-07-12
Enrollment: 35
Sex: MALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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).

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

Primary outcomes:
measure: Apnea/Hypopnea Index
timeFrame: 6 months after the basal evaluation
Secondary outcomes:
measure: Gene expression
timeFrame: 6 months after the basal evaluation
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: AFIP - Instituto do Sono (Sleep Institute)
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Juliana C Perry, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Associacao Fundo de Incentivo a Psicofarmacologia
name: Lia Rita A Bittencourt, MD, PhD
role: STUDY_DIRECTOR
References: