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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01022320
• Other study ID #: 0024.0.338.000-09
• Secondary ID: HSPE-001/09
• Status: Recruiting
• Phase: N/A
• First received: November 30, 2009
• Last updated: November 30, 2009
• Start date: May 2009
• Est. completion date: December 2010

Study information

• Verified date: November 2009
• Source: Hospital do Servidor Publico Estadual
• Contact: Carolina Soares, MD
• Phone: +551184856036
• Email: naliroca[@]hotmail.com
• Is FDA regulated: No
• Health authority: Brazil: Ministry of HealthBrazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical 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.

Description:

The variables are:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• High Blood Pressure
• Hypertension
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
Brazil	Hospital do Servidor Estadual de São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital do Servidor Publico Estadual

Country where clinical trial is conducted

Brazil,