NCT01574768

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 10, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

April 10, 2012

Status Verified

April 1, 2012

Enrollment Period

9 months

First QC Date

April 7, 2012

Last Update Submit

April 7, 2012

Conditions

SnoreObstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • AHI

    Change in AHI

    6 months

Interventions

Lateral PharyngoplastyPROCEDURE

Tonsilectomy, microdissection of the superior pharyngeal constrictor muscle within the tonsillar fossa and sectioning of this muscle

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • snore
  • osas

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital do Servidor Público Estadual

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

SnoringSleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Respiratory SoundsSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsSleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Michel B Cahali, MD, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
otolaryngologist

Study Record Dates

First Submitted

April 7, 2012

First Posted

April 10, 2012

Study Start

November 1, 2011

Primary Completion

August 1, 2012

Study Completion

September 1, 2012

Last Updated

April 10, 2012

Record last verified: 2012-04

Locations

BR(1)