Obstructive Sleep Apnea and Genes Expression

Obstructive Sleep Apnea Clinical Trial

— HIP  

Official title:

Sleep Apnea: Interface Between Basic and Clinical Research

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01392339
• Other study ID #: 0985/08
• Status: Unknown status
• Phase: N/A
• First received: July 7, 2011
• Last updated: July 11, 2011
• Start date: February 2011
• Est. completion date: October 2011

Study information

• Verified date: March 2011
• Source: Associacao Fundo de Incentivo a Psicofarmcologia
• Contact: Juliana C Perry, PhD
• Phone: 55-11-8636-9979
• Email: julianaciniperry[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 35
• Est. completion date: October 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
Brazil	AFIP - Instituto do Sono (Sleep Institute)	Sao Paulo	SP

Sponsors (3)

Lead Sponsor	Collaborator
Associacao Fundo de Incentivo a Psicofarmcologia	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea/Hypopnea Index	Polysomnographic date of sleep stages percentages, sleep efficiency, arousals, apnea-hypopnea index, oxyhemoglobin saturation	6 months after the basal evaluation
Secondary	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	6 months after the basal evaluation

External Links

•   American Academy of Sleep Medicine
•   Hypoxia Signaling Pathway PCR Array (SA Biosciences, EUA)