Sleep Apnea, ObstructiveNCT01427075
Evaluation Of The Pharynx in Patients Undergoing Lateral Pharyngoplasty
A study testing LATERAL PHARYNGOPLASTY in people with Sleep Apnea, Obstructive, run by Hospital do Servidor Publico Estadual at 1 site in Brazil.
Trial summary
This study will evaluate the pharynx in patients undergoing lateral pharyngoplasty for treatment of obstructive sleep apnea through MRI, before and 6 months after surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- LATERAL PHARYNGOPLASTY
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2011to Nov 2012
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of obstructive sleep apnea syndrome
Who cannot join
- MRI contraindications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Pharynx Through MRI in Patients Undergoing Lateral Pharyngoplasty for Treatment of Obstructive Sleep Apnea
This study will evaluate the pharynx in patients undergoing lateral pharyngoplasty for treatment of obstructive sleep apnea through MRI, before and 6 months after surgery.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- LATERAL PHARYNGOPLASTY
- Keywords
- Magnetic Resonance Imaging, Sleep Apnea, Obstructive, Pharyngeal Muscles
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LATERAL PHARYNGOPLASTYProcedure or surgery
tonsilectomy and lateral pharyngoplasty
| Study group | Role | What they receive |
|---|---|---|
| lateral pharyngoplasty | Experimental | lateral pharyngoplasty Receives: Procedure: LATERAL PHARYNGOPLASTY |
What is being measured
The primary outcome is the main question the study is designed to answer.
expansion of pharynx
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2011 (estimated)
- Study startMar 2011
- Primary completionNov 2012 (estimated)
- Study completionNov 2012 (estimated)
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital do Servidor Publico Estadual
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CAROLINA DE ANDRADE FERREIRA VIEIRA, Hospital do Servidor Publico Estadual
- Investigators
- CAROLINA AF VIEIRA, MD, Principal investigator, Hospital do Servidor Publico Estadual
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01427075
- Sponsor's protocol ID
- 018/11
- Status last verified
- Apr 2012
- First submitted
- 30 Aug 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
- Evaluation of the Pharynx Through MRI in Patients Undergoing Lateral Pharyngoplasty for Treatment of Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT01427075
- Acronym / sponsor ID
- 018/11
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Magnetic Resonance Imaging, Sleep Apnea, Obstructive, Pharyngeal Muscles
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Hospital do Servidor Publico EstadualUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 1 Sep 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.
This study will evaluate the pharynx in patients undergoing lateral pharyngoplasty for treatment of obstructive sleep apnea through MRI, before and 6 months after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lateral pharyngoplasty | Experimental | Procedure: LATERAL PHARYNGOPLASTYlateral pharyngoplasty |
Who may qualify
- Ages
- 18 to 65 years
- 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 (1 listed)
- MRI contraindications
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 |
|---|---|---|
| LATERAL PHARYNGOPLASTYtonsilectomy and lateral pharyngoplasty | Procedure or surgery | lateral pharyngoplasty |
Primary outcome
expansion of pharynx
Time frame: 6 months
Results and safety
Results are not available in the source record.
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.
CAROLINA AF VIEIRA, MD principal investigator
Hospital do Servidor Publico Estadual
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LATERAL PHARYNGOPLASTY in people with Sleep Apnea, Obstructive, 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: status not confirmed, 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?
Results are not available in the source record.
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?
expansion of pharynx (time frame: 6 months). 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.