Obstructive Sleep ApneaHIPNCT01392339
Obstructive Sleep Apnea and Genes Expression
A study testing Continuous Positive Airway Pressure (CPAP) in people with Obstructive Sleep Apnea, run by Associacao Fundo de Incentivo a Psicofarmcologia at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 30 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Continuous Positive Airway Pressure (CPAP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2011to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
AFIP - Instituto do Sono (Sleep Institute)
São Paulo, São Paulo, 04020-060
Juliana C Perry, PhD, 55-11-8636-9979, julianaciniperry@gmail.com
Silverio A Garbuio, Master, 55-11-8611-9251, silverio.garbuio@gmail.com
About this study
Official title: 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.
Read the 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).
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Continuous Positive Airway Pressure (CPAP)
- Keywords
- Obstructive Sleep Apnea, CPAP, hypoxia, sleep, translational science, gene expression
- Medical subject headings
- Sleep Apnea, Obstructive, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Positive Airway Pressure (CPAP)Procedure or surgery
Continuous Positive Airway Pressure (CPAP) is a method of respiratory ventilation used primarily in the treatment of obstructive sleep apnea
| Study group | Role | What they receive |
|---|---|---|
| CPAP | Experimental | CPAP - Continuous Positive Airway Pressure, gold standard treatment to Obstructive Sleep Apnea Receives: Procedure: Continuous Positive Airway Pressure (CPAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea/Hypopnea Index
Polysomnographic date of sleep stages percentages, sleep efficiency, arousals, apnea-hypopnea index, oxyhemoglobin saturation
Measured: 6 months after the basal evaluation
Secondary outcomes (1)
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
Measured: 6 months after the basal evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study startFeb 2011
- Primary completionJul 2011
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Associacao Fundo de Incentivo a Psicofarmcologia
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo
- Investigators
- Juliana C Perry, PhD, Principal investigator, Federal University of São PauloLia Rita A Bittencourt, MD, PhD, Study director, Associacao Fundo de Incentivo a Psicofarmacologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01392339
- Sponsor's protocol ID
- 0985/08
- Acronym
- HIP
- Status last verified
- Mar 2011
- First submitted
- 7 Jul 2011
- Last updated
- 12 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Apnea: Interface Between Basic and Clinical Research
- ClinicalTrials.gov ID
- NCT01392339
- Acronym / sponsor ID
- HIP / 0985/08
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive Sleep Apnea, CPAP, hypoxia, sleep, translational science, gene expression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Associacao Fundo de Incentivo a PsicofarmcologiaUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Feb 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Oct 2011 (estimated)
- First posted
- 12 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPAP | Experimental | Procedure: Continuous Positive Airway Pressure (CPAP)CPAP - Continuous Positive Airway Pressure, gold standard treatment to Obstructive Sleep Apnea |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | CPAP |
Primary outcome
Apnea/Hypopnea Index
Time frame: 6 months after the basal evaluation
Polysomnographic date of sleep stages percentages, sleep efficiency, arousals, apnea-hypopnea index, oxyhemoglobin saturation
1 secondary outcome
Gene expression
Time frame: 6 months after the basal evaluation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2011.
- Hypoxia Signaling Pathway PCR Array (SA Biosciences, EUA)Link provided by the sponsor.
- American Academy of Sleep MedicineLink provided by the sponsor.
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Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea
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Oxytocin for Respiratory Compromise and Hypoventilation Induced by Drugs
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Enrolling by invitation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juliana C Perry, PhD principal investigator
Federal University of São Paulo
Lia Rita A Bittencourt, MD, PhD study director
Associacao Fundo de Incentivo a Psicofarmacologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Positive Airway Pressure (CPAP) in people with Obstructive Sleep Apnea, run by Associacao Fundo de Incentivo a Psicofarmcologia at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juliana C Perry, PhD (55-11-8636-9979, julianaciniperry@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea/Hypopnea Index (time frame: 6 months after the basal evaluation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2011.