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

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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

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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea High Blood Pressure Procedure: Lateral Pharyngoplasty Not Applicable

Detailed Description:

The variables are:

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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Lateral Pharyngoplasty on Blood Pressure in Obstructive Sleep Apnea Patients
Study Start Date : May 2009
Estimated Primary Completion Date : June 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: Surgical outcome
20 consecutive cases of patients who underwent the lateral pharyngoplasty
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.





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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01022320


Contacts
Contact: Carolina Soares, MD +551184856036 naliroca@hotmail.com
Contact: Michel Cahali, MD +5088800

Locations
Brazil
Hospital do Servidor Estadual de São Paulo Recruiting
São Paulo, Brazil, 040000
Contact: Carolina Soares, MD       naliroca@hotmail.com   
Contact: Michel Cahali, MD       mcahali@igmail.com   
Principal Investigator: Carolina Soares, MD         
Sponsors and Collaborators
Hospital do Servidor Publico Estadual
Investigators
Principal Investigator: Carolina Soares, MD HSPE

Responsible Party: Carolina Ferraz de Paula Soares, HSPE
ClinicalTrials.gov Identifier: NCT01022320     History of Changes
Other Study ID Numbers: 0024.0.338.000-09
HSPE-001/09 ( Registry Identifier: Otorhinolaryngology department of HSPE )
First Posted: December 1, 2009    Key Record Dates
Last Update Posted: December 1, 2009
Last Verified: November 2009

Keywords provided by Hospital do Servidor Publico Estadual:
OSA
Blood pressure
Lateral Pharyngoplasty

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Hypertension
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases