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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


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, 

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