Obstructive Sleep Apnea SyndromeNCT01315535
Fast Titration of Oral Appliance at Obstructive Sleep Apnea Syndrome (OSAS) Treatment
An observational study of Obstructive Sleep Apnea Syndrome, run by Associacao Fundo de Incentivo a Psicofarmcologia at 1 site in Brazil.
Trial summary
The literature does not discuss if the fast oral appliance titration (30 days period) in Obstructive Sleep Apnea Syndrome (OSAS) treatment, may improve subjects quality of life in such brief period. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2011to Dec 2013
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects diagnosed with mild to moderate osas, according to the aasm criteria (2005) from the respiratory disorders clinic (UNIFESP) referred to oral appliance treatment.
Who may be able to join
- BMI ≤ 35kg/m2
- MILD TO MODERATE OSAS DIAGNOSIS ACCORDING TO THE AASM CRITERIA (2005)
- Negative TMD diagnosis (according to RDC/TMD)
Who cannot join
- DENTAL CONDITIONS THAT CONTRAINDICATED THE ORAL APLLIANCE USAGE
- SLEEP DISORDERS OTHER THAN OSAS
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Instituto Do Sono / Universidade Federal de São Paulo
São Paulo, São Paulo, 04039-032
LIA BITTENCOURT, PhD, 055-11-8234-1166, lia@pscicobio.epm.br
PAULO CUNALI, PhD, 055-41-96868668, pacunali@onda.com.br
About this study
Official title: Evaluation of the Efficacy and Side Effects of Fast Mandibular Advancement With Oral Appliance in the Treatment of Obstructive Sleep Apnea Syndrome
The literature does not discuss if the fast oral appliance titration (30 days period) in Obstructive Sleep Apnea Syndrome (OSAS) treatment, may improve subjects quality of life in such brief period. Temporomandibular dysfunction-related (TMD) is one of the most important side effects observed in OSAS treatment with oral appliance. Since the effectiveness of mandibular exercises in the control of TMD pain has already been verified, it may play a fundamental role in the support of the fast oral appliance titration.
- Conditions
- Obstructive Sleep Apnea Syndrome
- Keywords
- Mandibular Advancement, Oral Appliance, TMD
- 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 |
|---|---|---|
| Fast Titration | Not described | |
| Regular Titration | Not described | |
| Fast Tritation Including Mandibular Exercises | Not described | |
| Regular Tritation Including Mandibular Exercises | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2011 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea SyndromeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Associacao Fundo de Incentivo a Psicofarmcologia
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01315535
- Sponsor's protocol ID
- CEP0301/10
- Status last verified
- Mar 2011
- First submitted
- 14 Mar 2011
- Last updated
- 23 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Side Effects of Fast Mandibular Advancement With Oral Appliance in the Treatment of Obstructive Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT01315535
- Acronym / sponsor ID
- CEP0301/10
- Conditions
- Obstructive Sleep Apnea Syndrome
- Keywords
- Mandibular Advancement, Oral Appliance, TMD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Associacao Fundo de Incentivo a PsicofarmcologiaUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 15 Mar 2011 (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 literature does not discuss if the fast oral appliance titration (30 days period) in Obstructive Sleep Apnea Syndrome (OSAS) treatment, may improve subjects quality of life in such brief period. Temporomandibular dysfunction-related (TMD) is one of the most important side effects observed in OSAS treatment with oral appliance. Since the effectiveness of mandibular exercises in the control of TMD pain has already been verified, it may play a fundamental role in the support of the fast oral appliance titration.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fast Titration | – | – |
| Regular Titration | – | – |
| Fast Tritation Including Mandibular Exercises | – | – |
| Regular Tritation Including Mandibular Exercises | – | – |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects diagnosed with mild to moderate osas, according to the aasm criteria (2005) from the respiratory disorders clinic (UNIFESP) referred to oral appliance treatment.
Key inclusion criteria (3 listed)
- BMI ≤ 35kg/m2
- MILD TO MODERATE OSAS DIAGNOSIS ACCORDING TO THE AASM CRITERIA (2005)
- Negative TMD diagnosis (according to RDC/TMD)
Key exclusion criteria (2 listed)
- DENTAL CONDITIONS THAT CONTRAINDICATED THE ORAL APLLIANCE USAGE
- SLEEP DISORDERS OTHER THAN OSAS
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 23 Jun 2011.
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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.
Instituto Do Sono / Universidade Federal de São Paulo
São Paulo, Brazil
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 Syndrome, run by Associacao Fundo de Incentivo a Psicofarmcologia 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 3 inclusion and 2 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 23 Jun 2011. 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?
Each site lists its own contact: choose the nearest one under Trial locations. 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 23 Jun 2011.