Obstructive Sleep Apnea and Genes Expression
HIP
Sleep Apnea: Interface Between Basic and Clinical Research
1 other identifier
interventional
35
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 7, 2011
CompletedFirst Posted
Study publicly available on registry
July 12, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedJuly 12, 2011
March 1, 2011
5 months
July 7, 2011
July 11, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Apnea/Hypopnea Index
Polysomnographic date of sleep stages percentages, sleep efficiency, arousals, apnea-hypopnea index, oxyhemoglobin saturation
6 months after the basal evaluation
Secondary Outcomes (1)
Gene expression
6 months after the basal evaluation
Study Arms (1)
CPAP
EXPERIMENTALCPAP - Continuous Positive Airway Pressure, gold standard treatment to Obstructive Sleep Apnea
Interventions
Continuous Positive Airway Pressure (CPAP) is a method of respiratory ventilation used primarily in the treatment of obstructive sleep apnea
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AFIP - Instituto do Sono (Sleep Institute)
São Paulo, São Paulo, 04020-060, Brazil
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 7, 2011
First Posted
July 12, 2011
Study Start
February 1, 2011
Primary Completion
July 1, 2011
Study Completion
October 1, 2011
Last Updated
July 12, 2011
Record last verified: 2011-03