OBSTRUCTIVE SLEEP APNEANCT01157286
Obstructive Apnea in Patients Submitted to Partial Laryngectomy
An observational study of OBSTRUCTIVE SLEEP APNEA, run by Hospital do Servidor Publico Estadual at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- OBSTRUCTIVE SLEEP APNEA
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2010to Oct 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: PATIENTS OVER 18 YEARS, SUBMITED IN THE LAST 15 YEARS TO PARTIAL LARINGECTOMY IFNO TRACHEOSTOMY IS PRESENT
Who may be able to join
- PARTIAL LARINGECTOMY, OVER 18 YEARS,
Who cannot join
- TRACHEOSTOMY DEPRESSION USE OF DRUGS SEVERE DPOC CANCER RECURRENCE
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto de Assistência Médica ao Servidor Público Estadual
São Paulo, 040039901
teixeira, 55 61 82222073, raquelch@bol.com.br
raquel teixeira, resident
About this study
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.
Read the detailed description
We are trying to avaliate the residual glotic area using spirometry e laryngoscopy
- Conditions
- OBSTRUCTIVE SLEEP APNEA
- Keywords
- OBSTRUCTIVE SLEEP APNEA LARINGECTOMY CPAP
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| level of apnea | patients will be separated depending on the iah(apnea hypopnea index) in mild, moderate and severe |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionJul 2011 (estimated)
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OBSTRUCTIVE SLEEP APNEAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital do Servidor Publico Estadual
- Sponsor type
- University, hospital or other
- Investigators
- raquel teixeira, doctor, Principal investigator, HSPERaquel Teixeira, doctor, Principal investigator, pos graduatin student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01157286
- Sponsor's protocol ID
- SAOS1
- Status last verified
- Jul 2010
- First submitted
- 6 Jul 2010
- Last updated
- 12 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstructive Apnea in Patients Submitted to Partial Laryngectomy
- ClinicalTrials.gov ID
- NCT01157286
- Acronym / sponsor ID
- SAOS1
- Conditions
- OBSTRUCTIVE SLEEP APNEA
- Keywords
- OBSTRUCTIVE SLEEP APNEA LARINGECTOMY CPAP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospital do Servidor Publico EstadualUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 7 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
We are trying to avaliate the residual glotic area using spirometry e laryngoscopy
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| level of apnea | – | –patients will be separated depending on the iah(apnea hypopnea index) in mild, moderate and severe |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- PATIENTS OVER 18 YEARS, SUBMITED IN THE LAST 15 YEARS TO PARTIAL LARINGECTOMY IFNO TRACHEOSTOMY IS PRESENT
Key inclusion criteria (1 listed)
- PARTIAL LARINGECTOMY, OVER 18 YEARS,
Key exclusion criteria (1 listed)
- TRACHEOSTOMY DEPRESSION USE OF DRUGS SEVERE DPOC CANCER RECURRENCE
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
raquel teixeira, doctor principal investigator
HSPE
Raquel Teixeira, doctor principal investigator
pos graduatin student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of OBSTRUCTIVE SLEEP APNEA, run by Hospital do Servidor Publico Estadual at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact RAQUEL C TEIXEIRA, RESIDENT (55 61 82222073, raquelch@bol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2018.