NCT01427075

Brief Summary

This study will evaluate the pharynx in patients undergoing lateral pharyngoplasty for treatment of obstructive sleep apnea through MRI, before and 6 months after surgery.

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
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2011

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

March 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

April 10, 2012

Status Verified

April 1, 2012

Enrollment Period

1.7 years

First QC Date

August 30, 2011

Last Update Submit

April 7, 2012

Conditions

Sleep Apnea, Obstructive

Keywords

Magnetic Resonance ImagingSleep Apnea, ObstructivePharyngeal Muscles

Outcome Measures

Primary Outcomes (1)

  • expansion of pharynx

    6 months

Study Arms (1)

lateral pharyngoplasty

EXPERIMENTAL

lateral pharyngoplasty

Procedure: LATERAL PHARYNGOPLASTY

Interventions

LATERAL PHARYNGOPLASTYPROCEDURE

tonsilectomy and lateral pharyngoplasty

lateral pharyngoplasty

Eligibility Criteria

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

You may qualify if:

  • diagnosis of obstructive sleep apnea syndrome

You may not qualify if:

  • MRI contraindications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Do Servidor Publico Estadual

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • CAROLINA AF VIEIRA, MD

    Hospital do Servidor Publico Estadual

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
VIEIRA, CAF

Study Record Dates

First Submitted

August 30, 2011

First Posted

September 1, 2011

Study Start

March 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

April 10, 2012

Record last verified: 2012-04

Locations

BR(1)