NCT01022320

Brief 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.

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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2009

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

May 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

December 1, 2009

Status Verified

November 1, 2009

Enrollment Period

1.1 years

First QC Date

November 30, 2009

Last Update Submit

November 30, 2009

Conditions

Obstructive Sleep ApneaHigh Blood Pressure

Keywords

OSABlood pressureLateral Pharyngoplasty

Study Arms (1)

Surgical outcome

EXPERIMENTAL

20 consecutive cases of patients who underwent the lateral pharyngoplasty

Procedure: Lateral Pharyngoplasty

Interventions

Lateral PharyngoplastyPROCEDURE

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.

Surgical outcome

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult Patient
  • BMI \< 35
  • no Benzodiazepinec User

You may not qualify if:

  • BMI \> 35
  • Use of benzodiazepinecs
  • Clinical contra-indications to surgery (ASA III or ASA IV)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital do Servidor Estadual de São Paulo

São Paulo, São Paulo, 040000, Brazil

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, ObstructiveHypertension

Condition Hierarchy (Ancestors)

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

Study Officials

  • Carolina Soares, MD

    HSPE

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carolina Soares, MD

CONTACT

+551184856036naliroca@hotmail.com

Michel Cahali, MD

CONTACT

+5088800

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 30, 2009

First Posted

December 1, 2009

Study Start

May 1, 2009

Primary Completion

June 1, 2010

Study Completion

December 1, 2010

Last Updated

December 1, 2009

Record last verified: 2009-11

Locations

BR(1)