LATERAL PHARYNGOPLASTY OUTCOMES IN THE TREATMENT OF SNORE AND OBSTRUCTIVE SLEEP APNEA

Obstructive Sleep Apnea Clinical Trial

Official title:

LATERAL PHARYNGOPLASTY OUTCOMES IN THE TREATMENT OF SNORE AND OBSTRUCTIVE SLEEP APNEA

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01574768
• Other study ID #: 135/11
• Status: Active, not recruiting
• Phase: N/A
• First received: April 7, 2012
• Last updated: April 7, 2012
• Start date: November 2011
• Est. completion date: September 2012

Study information

• Verified date: April 2012
• Source: Hospital do Servidor Publico Estadual
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to describe the results of Lateral Pharyngoplasty in the treatment of snore and OSAS.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: September 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• snore

• osas

Exclusion Criteria:

• previous pharynx surgery

• use of medication that modifies the muscular tonus or the perception of sleepiness before or after the surgery

• body mass index (BMI) bigger than 35 kg/m2

• neurological or psychiatric disease.

Study Design

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Snore

Intervention

Procedure:
• Lateral Pharyngoplasty
Tonsilectomy, microdissection of the superior pharyngeal constrictor muscle within the tonsillar fossa and sectioning of this muscle

Locations

Country	Name	City	State
Brazil	Hospital do Servidor Público Estadual	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Hospital do Servidor Publico Estadual	University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AHI	Change in AHI	6 months	No