Sleep ApneaNCT01576926
Evolution of Swallowing in Patients Undergoing Lateral Pharyngoplasty With Preservation Stylopharyngeal Muscle
An observational study of Sleep Apnea, run by Hospital do Servidor Publico Estadual at 1 site in Brazil.
Trial summary
Evolution of swallowing in patients undergoing lateral pharyngoplasty with preservation stylopharyngeal muscle. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea
- How many people
- 1 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2009to Feb 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with obstructive sleep apnea, indicating the lateral pharyngeal
Who may be able to join
- patients with obstructive sleep apnea with surgical indication
Who cannot join
- patients with obstructive sleep apnea without surgical indication
Trial locations and contacts
1 site in 1 country.
About this study
Evolution of swallowing in patients undergoing lateral pharyngoplasty with preservation stylopharyngeal muscle.
Read the detailed description
refer patients to the side pharyngoplasty with total preservation of stylopharyngeal muscle and evaluate the total recovery time of swallowing, making a daily assessment.
- Conditions
- Sleep Apnea
- Keywords
- Sleep apnea, obstructive, Deglutition Disorders
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Deglutition Disorders
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 |
|---|---|---|
| surgery | patients with obstructive sleep apnea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of swallowing in patients undergoing lateral pharyngoplasty with preservation stylopharyngeal muscle
refer patients with oas to the side faringolastia with total preservation stylopharyngeal muscle and evaluate recovery time of swallowing during 30 days.
Measured: assess progress daily until the end of swallowing dysphagia during 30 days
Secondary outcomes (1)
Evolution of swallowing in patients undergoing lateral pharyngoplasty with preservation stylopharyngeal muscle
refer patients with oas to the side faringolastia with total preservation styleopharingeal muscle and evaluate the total recovery time of swallowing, making a daily assessment.
Measured: assess progress daily until the end of swallowing dysphagia during 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2012 (estimated)
- Study startMar 2009
- Primary completionJun 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital do Servidor Publico Estadual
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jayson mesti, Hospital do Servidor Publico Estadual
- Investigators
- Jayson Mesti, medical, Principal investigator, Hopital Do Servidor Público Estadual
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01576926
- Sponsor's protocol ID
- 116/08
- Status last verified
- Apr 2012
- First submitted
- 9 Apr 2012
- Last updated
- 13 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of Swallowing in Patients Undergoing Lateral Pharyngoplasty With Preservation Stylopharyngeal Muscle
- ClinicalTrials.gov ID
- NCT01576926
- Acronym / sponsor ID
- 116/08
- Conditions
- Sleep Apnea
- Keywords
- Sleep apnea, obstructive, Deglutition Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Hospital do Servidor Publico EstadualUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 13 Apr 2012 (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.
Evolution of swallowing in patients undergoing lateral pharyngoplasty with preservation stylopharyngeal muscle.
Detailed description
refer patients to the side pharyngoplasty with total preservation of stylopharyngeal muscle and evaluate the total recovery time of swallowing, making a daily assessment.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| surgery | – | –patients with obstructive sleep apnea |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with obstructive sleep apnea, indicating the lateral pharyngeal
Key inclusion criteria (1 listed)
- patients with obstructive sleep apnea with surgical indication
Key exclusion criteria (1 listed)
- patients with obstructive sleep apnea without surgical indication
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
Evolution of swallowing in patients undergoing lateral pharyngoplasty with preservation stylopharyngeal muscle
Time frame: assess progress daily until the end of swallowing dysphagia during 30 days
refer patients with oas to the side faringolastia with total preservation stylopharyngeal muscle and evaluate recovery time of swallowing during 30 days.
1 secondary outcome
Evolution of swallowing in patients undergoing lateral pharyngoplasty with preservation stylopharyngeal muscle
Time frame: assess progress daily until the end of swallowing dysphagia during 30 days
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 13 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.
Jayson Mesti, medical principal investigator
Hopital Do Servidor Público Estadual
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 Sleep Apnea, run by Hospital do Servidor Publico Estadual 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 1 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 13 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?
Evolution of swallowing in patients undergoing lateral pharyngoplasty with preservation stylopharyngeal muscle (time frame: assess progress daily until the end of swallowing dysphagia during 30 days). 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 13 Apr 2012.