SnoreNCT01574768
LATERAL PHARYNGOPLASTY OUTCOMES IN THE TREATMENT OF SNORE AND OBSTRUCTIVE SLEEP APNEA
A study testing Lateral Pharyngoplasty in people with Snore and Obstructive Sleep Apnea, run by Hospital do Servidor Publico Estadual at 1 site in Brazil.
Trial summary
The aim of this study is to describe the results of Lateral Pharyngoplasty in the treatment of snore and OSAS. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Snore, Obstructive Sleep Apnea
- What is being tested?
- Lateral Pharyngoplasty
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2011to Sep 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
- snore
- osas
Who cannot join
- previous pharynx surgery
- use of medication that modifies the muscular tonus or the perception of sleepiness before or after the surgery
- body mass index (BMI) bigger than 35 kg/m2
- neurological or psychiatric disease.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to describe the results of Lateral Pharyngoplasty in the treatment of snore and OSAS.
- Conditions
- Snore, Obstructive Sleep Apnea
- Being tested
- Lateral Pharyngoplasty
- Medical subject headings
- Snoring, 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, microdissection of the superior pharyngeal constrictor muscle within the tonsillar fossa and sectioning of this muscle
What is being measured
The primary outcome is the main question the study is designed to answer.
AHI
Change in AHI
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 posted10 Apr 2012 (estimated)
- Study startNov 2011
- Primary completionAug 2012 (estimated)
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SnoreStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital do Servidor Publico Estadual
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo
- Responsible party
- Principal investigator, CAROLINA DE ANDRADE FERREIRA VIEIRA, Hospital do Servidor Publico Estadual
- Investigators
- Michel B Cahali, MD, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01574768
- Sponsor's protocol ID
- 135/11
- Status last verified
- Apr 2012
- First submitted
- 7 Apr 2012
- 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
- LATERAL PHARYNGOPLASTY OUTCOMES IN THE TREATMENT OF SNORE AND OBSTRUCTIVE SLEEP APNEA
- ClinicalTrials.gov ID
- NCT01574768
- Acronym / sponsor ID
- 135/11
- Conditions
- Snore, Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hospital do Servidor Publico EstadualUniversity, hospital or other
- Collaborators
- University of Sao Paulo
- Study start
- Nov 2011
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 10 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.
The aim of this study is to describe the results of Lateral Pharyngoplasty in the treatment of snore and OSAS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- snore
- osas
Key exclusion criteria (4 listed)
- previous pharynx surgery
- use of medication that modifies the muscular tonus or the perception of sleepiness before or after the surgery
- body mass index (BMI) bigger than 35 kg/m2
- neurological or psychiatric disease.
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, microdissection of the superior pharyngeal constrictor muscle within the tonsillar fossa and sectioning of this muscle | Procedure or surgery | – |
Primary outcome
AHI
Time frame: 6 months
Change in AHI
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.
Related trials for Snore
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Apnea, Sleep Disorders
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Prediction of Tongue Base Obstruction During Sleep
Obstructive Sleep Disordered Breathing
Active, not recruiting
The Impact of Technology in Obstructive Sleep Apnea Myofunctional Therapy
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Active, not recruiting
DISE: Phenotyping Obstruction Patterns
Obstructive Sleep Apnea
RecruitingPhase 1
Use of Passive Myofunctional Appliances for Snoring and Mild Obstructive Sleep Apnea
Sleep Apnea, Obstructive
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.
Michel B Cahali, MD, PhD principal investigator
University of 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 Lateral Pharyngoplasty in people with Snore and Obstructive 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 2 inclusion and 4 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?
AHI (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.