Obstructive Sleep ApneaNCT01022320
Effect of Lateral Pharyngoplasty on Blood Pressure in Obstructive Sleep Apnea (OSA) Patients
A study testing Lateral Pharyngoplasty in people with Obstructive Sleep Apnea and High Blood Pressure, run by Hospital do Servidor Publico Estadual at 1 site in Brazil.
Trial summary
Describe blood pressure changes on patients with OSA treated with lateral pharyngoplasty Compare the mean of systolic and diastolic blood pressure in 24 hours, average systolic and diastolic pressure during daytime and night and changes in the nocturnal decrease. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea, High Blood Pressure
- 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
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- May 2009to Dec 2010
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult Patient
- BMI < 35
- no Benzodiazepinec User
Who cannot join
- BMI > 35
- Use of benzodiazepinecs
- Clinical contra-indications to surgery (ASA III or ASA IV)
Trial locations and contacts
1 site in 1 country.
Michel Cahali, MD contact
Brazil1 site, 1 recruiting
- Recruiting
Hospital do Servidor Estadual de São Paulo
São Paulo, São Paulo, 040000
Carolina Soares, MD, naliroca@hotmail.com
Michel Cahali, MD, mcahali@igmail.com
About this study
Official title: Effect of Lateral Pharyngoplasty on Blood Pressure in Obstructive Sleep Apnea Patients
- Describe blood pressure changes on patients with OSA treated with lateral pharyngoplasty
- Compare the mean of systolic and diastolic blood pressure in 24 hours, average systolic and diastolic pressure during daytime and night and changes in the nocturnal decrease.
Read the detailed description
The variables are:
Ambulatory blood pressure data Snoring scale BMI neck circumference abdominal circumference medications and life style changes
- Conditions
- Obstructive Sleep Apnea, High Blood Pressure
- Being tested
- Lateral Pharyngoplasty
- Keywords
- OSA, Blood pressure, Lateral Pharyngoplasty
- Medical subject headings
- Sleep Apnea, Obstructive, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral PharyngoplastyProcedure or surgery
surgery lateral pharyngoplasty: consists on the section and rotation of the superior constrictor pharyngeal muscle associated with the ressection of the palatopharyngeus preserving the palatoglossus and mucosa of posterior and anterior tonsilar pillar , bilaterally.
| Study group | Role | What they receive |
|---|---|---|
| Surgical outcome | Experimental | 20 consecutive cases of patients who underwent the lateral pharyngoplasty Receives: Procedure: Lateral Pharyngoplasty |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2009 (estimated)
- Study startMay 2009
- Primary completionJun 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital do Servidor Publico Estadual
- Sponsor type
- University, hospital or other
- Investigators
- Carolina Soares, MD, Principal investigator, HSPE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01022320
- Sponsor's protocol ID
- 0024.0.338.000-09
- Other IDs
- HSPE-001/09
- Status last verified
- Nov 2009
- First submitted
- 30 Nov 2009
- Last updated
- 1 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lateral Pharyngoplasty on Blood Pressure in Obstructive Sleep Apnea Patients
- ClinicalTrials.gov ID
- NCT01022320
- Acronym / sponsor ID
- 0024.0.338.000-09
- Conditions
- Obstructive Sleep Apnea, High Blood Pressure
- Keywords
- OSA, Blood pressure, Lateral Pharyngoplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospital do Servidor Publico EstadualUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 1 Dec 2009 (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.
- Describe blood pressure changes on patients with OSA treated with lateral pharyngoplasty
- Compare the mean of systolic and diastolic blood pressure in 24 hours, average systolic and diastolic pressure during daytime and night and changes in the nocturnal decrease.
Detailed description
The variables are:
Ambulatory blood pressure data Snoring scale BMI neck circumference abdominal circumference medications and life style changes
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgical outcome | Experimental | Procedure: Lateral Pharyngoplasty20 consecutive cases of patients who underwent the lateral pharyngoplasty |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult Patient
- BMI < 35
- no Benzodiazepinec User
Key exclusion criteria (3 listed)
- BMI > 35
- Use of benzodiazepinecs
- Clinical contra-indications to surgery (ASA III or ASA IV)
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 Pharyngoplastysurgery lateral pharyngoplasty: consists on the section and rotation of the superior constrictor pharyngeal muscle associated with the ressection of the palatopharyngeus preserving the palatoglossus and mucosa of posterior and anterior tonsilar pillar , bilaterally. | Procedure or surgery | Surgical outcome |
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 1 Dec 2009.
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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.
Michel Cahali, MD contact
Carolina Soares, MD principal investigator
HSPE
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 Obstructive Sleep Apnea and High Blood Pressure, 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 3 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 1 Dec 2009. 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 Carolina Soares, MD (+551184856036, naliroca@hotmail.com), 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 1 Dec 2009.