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Effect of Lateral Pharyngoplasty on Blood Pressure in Obstructive Sleep Apnea (OSA) Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01022320
Recruitment Status : Unknown
Verified November 2009 by Hospital do Servidor Publico Estadual.
Recruitment status was:  Recruiting
First Posted : December 1, 2009
Last Update Posted : December 1, 2009
Sponsor:
Information provided by:
Hospital do Servidor Publico Estadual

Tracking Information
First Submitted Date  ICMJE November 30, 2009
First Posted Date  ICMJE December 1, 2009
Last Update Posted Date December 1, 2009
Study Start Date  ICMJE May 2009
Estimated Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Lateral Pharyngoplasty on Blood Pressure in Obstructive Sleep Apnea (OSA) Patients
Official Title  ICMJE Effect of Lateral Pharyngoplasty on Blood Pressure in Obstructive Sleep Apnea Patients
Brief 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.
Detailed Description

The variables are:

Ambulatory blood pressure data Snoring scale BMI neck circumference abdominal circumference medications and life style changes

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Obstructive Sleep Apnea
  • High Blood Pressure
Intervention  ICMJE Procedure: Lateral Pharyngoplasty
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 Arms  ICMJE Experimental: Surgical outcome
20 consecutive cases of patients who underwent the lateral pharyngoplasty
Intervention: Procedure: Lateral Pharyngoplasty
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November¬†30,¬†2009)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2010
Estimated Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adult Patient
  • BMI < 35
  • no Benzodiazepinec User

Exclusion Criteria:

  • BMI > 35
  • Use of benzodiazepinecs
  • Clinical contra-indications to surgery (ASA III or ASA IV)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01022320
Other Study ID Numbers  ICMJE 0024.0.338.000-09
HSPE-001/09 ( Registry Identifier: Otorhinolaryngology department of HSPE )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Carolina Ferraz de Paula Soares, HSPE
Study Sponsor  ICMJE Hospital do Servidor Publico Estadual
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Carolina Soares, MD HSPE
PRS Account Hospital do Servidor Publico Estadual
Verification Date November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP