Sleep Apnea, ObstructiveNCT01335594
Evaluation of Swallowing in Patients With Obstructive Sleep Apnea
A study testing clinical, endoscopical and manometric evaluation in people with Sleep Apnea, Obstructive, run by Luciana Almeida Moreira da Paz Oliveira at 1 site in Brazil.
Trial summary
The purpose of this study is to test the hypothesis that obstructive sleep apnea syndrome is associated with deviant pharyngeal swallowing function, using clinical, endoscopical and manometric evaluation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- clinical, endoscopical and manometric evaluation
- Type of treatment
- Surgery or procedure
- How many people
- 21 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2010to May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of obstructive sleep apnea syndrome
Who cannot join
- other causes of dysphagia
- pharyngeal surgery
- prior treatment for obstructive sleep apnea
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Assistência Médica ao Servidor Público Estadual
São Paulo, São Paulo
About this study
Official title: Clinical, Endoscopical and Manometric Evaluation of Swallowing in Obstructive Sleep Apnea Syndrome
The purpose of this study is to test the hypothesis that obstructive sleep apnea syndrome is associated with deviant pharyngeal swallowing function, using clinical, endoscopical and manometric evaluation.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- clinical, endoscopical and manometric evaluation
- Keywords
- Sleep apnea, obstructive, Deglutition Disorders, Manometry, Endoscopy
- Medical subject headings
- Sleep Apnea, Obstructive, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical, endoscopical and manometric evaluationProcedure or surgery
clinical evaluation: questionnaire endoscopical analysis manometry
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation of swallowing in obstructive sleep apnea
Measured: within the first 3 months after diagnostic
Secondary outcomes (2)
Manometric evaluation of swallowing in obstructive sleep apnea
Measured: within the first 3 months after diagnostic
Endoscopic evaluation of swallowing in obstructive sleep apnea
Measured: within the first 3 months after diagnostic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2011 (estimated)
- Study startFeb 2010
- Primary completionDec 2010
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luciana Almeida Moreira da Paz Oliveira
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Luciana Almeida Moreira da Paz Oliveira, Hospital do Servidor Publico Estadual
- Investigators
- Luciana A M da Paz Oliveira, Principal investigator, Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01335594
- Sponsor's protocol ID
- SAOS2011
- Status last verified
- Apr 2012
- First submitted
- 11 Apr 2011
- Last updated
- 10 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Endoscopical and Manometric Evaluation of Swallowing in Obstructive Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT01335594
- Acronym / sponsor ID
- SAOS2011
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Sleep apnea, obstructive, Deglutition Disorders, Manometry, Endoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Luciana Almeida Moreira da Paz OliveiraUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 14 Apr 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.
The purpose of this study is to test the hypothesis that obstructive sleep apnea syndrome is associated with deviant pharyngeal swallowing function, using clinical, endoscopical and manometric evaluation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnosis of obstructive sleep apnea syndrome
Key exclusion criteria (3 listed)
- other causes of dysphagia
- pharyngeal surgery
- prior treatment for obstructive sleep apnea
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 |
|---|---|---|
| clinical, endoscopical and manometric evaluationclinical evaluation: questionnaire endoscopical analysis manometry | Procedure or surgery | – |
Primary outcome
Clinical evaluation of swallowing in obstructive sleep apnea
Time frame: within the first 3 months after diagnostic
2 secondary outcomes
Manometric evaluation of swallowing in obstructive sleep apnea
Time frame: within the first 3 months after diagnostic
Endoscopic evaluation of swallowing in obstructive sleep apnea
Time frame: within the first 3 months after diagnostic
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2012.
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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.
Luciana A M da Paz Oliveira principal investigator
Instituto de Assistencia Medica ao Servidor Publico Estadual, Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clinical, endoscopical and manometric evaluation in people with Sleep Apnea, Obstructive, run by Luciana Almeida Moreira da Paz Oliveira 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 1 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: finished, as of the sponsor's last update on 10 Apr 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical evaluation of swallowing in obstructive sleep apnea (time frame: within the first 3 months after diagnostic). 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 10 Apr 2012.