Obstructive Sleep Apnea and Genes Expression (HIP)
Recruitment status was Recruiting
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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 |
- 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
- 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 |
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| 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 | |
| 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 | |
| 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 May 19, 2013