NCT01157286

Brief Summary

The investigators intend to study the prevalence of obstructive apnea in patients submitted to partial laryngectomy by larynx cancer. Volunteers will be evaluated using polissonografy. We will try to correlate the residual glotic area with the number of apneas per hour.

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 all trials

Timeline
Completed

Started Jun 2010

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

June 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 6, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 7, 2010

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

March 12, 2018

Status Verified

July 1, 2010

Enrollment Period

1.1 years

First QC Date

July 6, 2010

Last Update Submit

March 9, 2018

Conditions

OBSTRUCTIVE SLEEP APNEA

Keywords

OBSTRUCTIVE SLEEP APNEA LARINGECTOMY CPAP

Study Arms (1)

level of apnea

patients will be separated depending on the iah(apnea hypopnea index) in mild, moderate and severe

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

PATIENTS OVER 18 YEARS, SUBMITED IN THE LAST 15 YEARS TO PARTIAL LARINGECTOMY IFNO TRACHEOSTOMY IS PRESENT

You may qualify if:

  • PARTIAL LARINGECTOMY, OVER 18 YEARS,

You may not qualify if:

  • TRACHEOSTOMY DEPRESSION USE OF DRUGS SEVERE DPOC CANCER RECURRENCE

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Assistência Médica ao Servidor Público Estadual

São Paulo, 040039901, Brazil

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • raquel teixeira, doctor

    HSPE

    PRINCIPAL INVESTIGATOR

  • Raquel Teixeira, doctor

    pos graduatin student

    PRINCIPAL INVESTIGATOR

Central Study Contacts

RAQUEL C TEIXEIRA, RESIDENT

CONTACT

55 61 82222073raquelch@bol.com.br

MICHEL B CAHALI, STAF

CONTACT

55 11 99519941mcahali@gmail.com

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 6, 2010

First Posted

July 7, 2010

Study Start

June 1, 2010

Primary Completion

July 1, 2011

Study Completion

October 1, 2011

Last Updated

March 12, 2018

Record last verified: 2010-07

Locations

BR(1)