Obstructive Sleep Apnea SyndromeNCT01455077
Portable Monitoring Device for the Diagnosis of Sleep Apnea in Obese Patients
An observational study of Obstructive Sleep Apnea Syndrome and Obesity, run by Associacao Fundo de Incentivo a Psicofarmcologia at 1 site in Brazil.
Trial summary
Introduction The portable monitoring system (PMS) recording of cardiopulmonary parameters (level III of ASDA) has been validated in subjects with high probability of Obstructive Sleep Apnea (OSA) without comorbidities. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome, Obesity
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2011to Jan 2012
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults BMI > 35 Male and female
Who may be able to join
- BMI > 35
- Complaints of snoring, sleep apnea, daytime sleepiness
Who cannot join
- use of home oxygen
- other sleep diseases
- inability to perform PSG
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Associacao Fundo de Incentivo a Psicofarmacologia
São Paulo, São Paulo
Lia R Bittencourt, MD, PhD, 55 11 21490155, lia@psicobio.epm.br
Erika C Treptow, erikatpw@hotmail.com
About this study
Official title: Validation of a Portable Monitoring System for the Diagnosis of Obstructive Sleep Apnea Syndrome in Patients With Level II and III Obesity
Introduction The portable monitoring system (PMS) recording of cardiopulmonary parameters (level III of ASDA) has been validated in subjects with high probability of Obstructive Sleep Apnea (OSA) without comorbidities.
However, there is not any study evaluating this system when OSA is associated with morbid obesity, so the validation of PMS will be very useful in order to properly work-up this highly risk population.
Read more
Objective:
To evaluate the accuracy of level III type of PMS - Stardust™" (STD), on patients with level II and III of obesity and high clinical suspicion of OSA.
Methods:Participants with BMI > 35 kg/m2 and with suspicion of OSA will consecutively be selected from an Outpatients Sleep Clinic of UNIFESP. They will be randomized for the following order of recordings:
- STD at home for 1 night 2) STD in the sleep lab simultaneous to PSG. AHI will be taken for subsequent analysis:a) AHI PSG b) AHI STD -lab and c) AHI STD- home.
- Conditions
- Obstructive Sleep Apnea Syndrome, Obesity
- Keywords
- obesity, sleep apnea, portable monitoring
- Medical subject headings
- Sleep Apnea, Obstructive, Obesity, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Obese patients | BMI > 35 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2011
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea SyndromeStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Associacao Fundo de Incentivo a Psicofarmcologia
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of São Paulo
- Responsible party
- Principal investigator, Prof. Dr. Lia Azeredo-Bittencourt, Associacao Fundo de Incentivo a Psicofarmcologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01455077
- Sponsor's protocol ID
- CEP0290/11
- Other IDs
- Portable monitoring system for, STD obesity
- Status last verified
- Oct 2011
- First submitted
- 15 Oct 2011
- Last updated
- 19 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Portable Monitoring System for the Diagnosis of Obstructive Sleep Apnea Syndrome in Patients With Level II and III Obesity
- ClinicalTrials.gov ID
- NCT01455077
- Acronym / sponsor ID
- CEP0290/11
- Conditions
- Obstructive Sleep Apnea Syndrome, Obesity
- Keywords
- obesity, sleep apnea, portable monitoring
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Associacao Fundo de Incentivo a PsicofarmcologiaUniversity, hospital or other
- Collaborators
- Federal University of São Paulo
- Study start
- Jan 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jan 2012 (estimated)
- First posted
- 19 Oct 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.
Introduction The portable monitoring system (PMS) recording of cardiopulmonary parameters (level III of ASDA) has been validated in subjects with high probability of Obstructive Sleep Apnea (OSA) without comorbidities.
However, there is not any study evaluating this system when OSA is associated with morbid obesity, so the validation of PMS will be very useful in order to properly work-up this highly risk population.
Objective:
To evaluate the accuracy of level III type of PMS - Stardust™" (STD), on patients with level II and III of obesity and high clinical suspicion of OSA.
Methods:Participants with BMI > 35 kg/m2 and with suspicion of OSA will consecutively be selected from an Outpatients Sleep Clinic of UNIFESP. They will be randomized for the following order of recordings:
- STD at home for 1 night 2) STD in the sleep lab simultaneous to PSG. AHI will be taken for subsequent analysis:a) AHI PSG b) AHI STD -lab and c) AHI STD- home.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obese patients | – | –BMI > 35 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults BMI > 35 Male and female
Key inclusion criteria (2 listed)
- BMI > 35
- Complaints of snoring, sleep apnea, daytime sleepiness
Key exclusion criteria (3 listed)
- use of home oxygen
- other sleep diseases
- inability to perform PSG
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2011.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea Syndrome and Obesity, 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 2 inclusion and 3 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 19 Oct 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 Lia R Bittencourt, MD, PhD (55 11 21490155, lia@psicobio.epm.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 19 Oct 2011.