Primary Snore, Obstructive Sleep Apnea (Mild and Moderate).EOENCT01636856
Effects of Oropharyngeal Exercises on Patients With Primary Snore, Mild and Moderate Obstructive
A study testing Oropharyngeal exercises and Respiratory exercises, nasal dilator, nasal lavage in people with Primary Snore, Obstructive Sleep Apnea (Mild and Moderate)., run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Randomized study of patients with primary snore, mild and moderate obstructive sleep apnea. Protocol include 40 patients randomized to oropharyngeal exercise or use of nasal dilator, breathing exercise and nasal lavage. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Snore, Obstructive Sleep Apnea (Mild and Moderate).
- What is being tested?
- Oropharyngeal exercises and Respiratory exercises, nasal dilator, nasal lavage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2011to Dec 2015
- Phase
- Interventional
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- subjects with primary snore, mild and moderate obstructive sleep apnea
Who cannot join
- BMI > or = 40, craniofacial malformations, smokers, pregnant women, edentulous, total dental prostheses, use of hypnotic medications, stroke, neuromuscular dystrophy, coronary artery disease, chronic heart failure, chronic obstructive pulmonary disease, severe nasal obstructive disease, pharyngeal surgery,already made some kind of treatment for obstructive sleep apnea.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Incor- Heart Institute, Sleep Laboratory
São Paulo, São Paulo, 05403-904
Geraldo Lorenzi-Filho, MD, PhD, 55 (0xx) 11- 2661-5486, geraldo.lorenzi@gmail.com
Pedro Rodrigues Genta, MD, PhD
About this study
Official title: Effects of Oropharyngeal Exercises on Snoring Intensity, Symptoms, Upper Airway Anatomy and Collapsability of Upper Airway Awake and Asleep in Patients With Primary Snoring and Mild to Moderate Obstructive Sleep Apnea
Randomized study of patients with primary snore, mild and moderate obstructive sleep apnea. Protocol include 40 patients randomized to oropharyngeal exercise or use of nasal dilator, breathing exercise and nasal lavage. The objectives are study the effects of therapy on oropharyngeal in a series of clinical and physiologic and anatomic variables, changes on snore and quality of sleep using Pharyngeal Critical Pressure, Magnetic Resonance, Negative expiratory pressure and snore analyses. Hypothesis that the therapy group (oropharyngeal exercises) will have more modifications compared to the control group.
Read the detailed description
This is randomized study with multiple primary endpoints. In December 2012 the study also started collecting tongue strength and endurance (IOPI). Because not all patients are able to perform all evaluations, the publications will be divided and presented according to the completion of the required number of patients for each primary endpoint.
- Being tested
- Oropharyngeal exercises, Respiratory exercises, nasal dilator, nasal lavage
- Keywords
- oropharyngeal exercises, obstructive sleep apnea, speech therapy, magnetic resonance, PCRIT, negative expiratory pressure, snore
- Medical subject headings
- Sleep Apnea, Obstructive, Lymphoma, Follicular, Communication Disorders, Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oropharyngeal exercisesBehavioural
Oropharyngeal exercises (derived from speech language pathology) to the soft palate, tongue and facial muscles exercises as well as stomatognathic functions.
Respiratory exercises, nasal dilator, nasal lavageBehavioural
Respiratory exercises, nasal dilator, nasal lavage
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Oropharyngeal exercises and oropharyngeal functions Receives: Behavioral: Oropharyngeal exercises |
| 2 | Sham comparator | Nasal dilator, respiratory exercise, nasal lavage Receives: Behavioral: Respiratory exercises, nasal dilator, nasal lavage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper airway collapsability
Measured: 3 months
Images from magnetic resonance
Measured: 3 months
Negative expiratory pressure
Measured: 3 months
Snore
Measured: 3 months
Secondary outcomes (1)
Sleep related questionnaires
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study startDec 2011
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Snore, Obstructive Sleep Apnea (Mild and Moderate).Studies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Geraldo Lorenzi-Filho, University of Sao Paulo
- Investigators
- Vanessa Ieto, Principal investigator, Heart Institute - InCorFabiane Kayamori, Principal investigator, Heart Institute - InCorGeraldo Lorenzi-Filho, MD, PhD, Principal investigator, Heart Institute - InCor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01636856
- Sponsor's protocol ID
- 3604/11/022
- Acronym
- EOE
- Status last verified
- May 2014
- First submitted
- 5 Jul 2012
- Last updated
- 28 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ieto V, Kayamori F, Montes MI, Hirata RP, Gregorio MG, Alencar AM, Drager LF, Genta PR, Lorenzi-Filho G. Effects of Oropharyngeal Exercises on Snoring: A Randomized Trial. Chest. 2015 Sep;148(3):683-691. doi: 10.1378/chest.14-2953.
PubMed 25950418
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oropharyngeal Exercises on Snoring Intensity, Symptoms, Upper Airway Anatomy and Collapsability of Upper Airway Awake and Asleep in Patients With Primary Snoring and Mild to Moderate Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT01636856
- Acronym / sponsor ID
- EOE / 3604/11/022
- Keywords
- oropharyngeal exercises, obstructive sleep apnea, speech therapy, magnetic resonance, PCRIT, negative expiratory pressure, snore
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Dec 2011
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 10 Jul 2012 (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.
Randomized study of patients with primary snore, mild and moderate obstructive sleep apnea. Protocol include 40 patients randomized to oropharyngeal exercise or use of nasal dilator, breathing exercise and nasal lavage. The objectives are study the effects of therapy on oropharyngeal in a series of clinical and physiologic and anatomic variables, changes on snore and quality of sleep using Pharyngeal Critical Pressure, Magnetic Resonance, Negative expiratory pressure and snore analyses. Hypothesis that the therapy group (oropharyngeal exercises) will have more modifications compared to the control group.
Detailed description
This is randomized study with multiple primary endpoints. In December 2012 the study also started collecting tongue strength and endurance (IOPI). Because not all patients are able to perform all evaluations, the publications will be divided and presented according to the completion of the required number of patients for each primary endpoint.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Oropharyngeal exercisesOropharyngeal exercises and oropharyngeal functions |
| 2 | Sham comparator | Behavioral: Respiratory exercises, nasal dilator, nasal lavageNasal dilator, respiratory exercise, nasal lavage |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- subjects with primary snore, mild and moderate obstructive sleep apnea
Key exclusion criteria (1 listed)
- BMI > or = 40, craniofacial malformations, smokers, pregnant women, edentulous, total dental prostheses, use of hypnotic medications, stroke, neuromuscular dystrophy, coronary artery disease, chronic heart failure, chronic obstructive pulmonary disease, severe nasal obstructive disease, pharyngeal surgery,already made some kind of treatment for obstructive sleep apnea.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oropharyngeal exercisesOropharyngeal exercises (derived from speech language pathology) to the soft palate, tongue and facial muscles exercises as well as stomatognathic functions. | Behavioural | 1 |
| Respiratory exercises, nasal dilator, nasal lavageRespiratory exercises, nasal dilator, nasal lavage | Behavioural | 2 |
Primary outcome
Upper airway collapsability
Time frame: 3 months
Images from magnetic resonance
Time frame: 3 months
Negative expiratory pressure
Time frame: 3 months
Snore
Time frame: 3 months
1 secondary outcome
Sleep related questionnaires
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2014.
- Derived from this study: PubMed 25950418Ieto V, Kayamori F, Montes MI, Hirata RP, Gregorio MG, Alencar AM, Drager LF, Genta PR, Lorenzi-Filho G. Effects of Oropharyngeal Exercises on Snoring: A Randomized Trial. Chest. 2015 Sep;148(3):683-691. doi: 10.1378/chest.14-2953.
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.
Vanessa Ieto principal investigator
Heart Institute - InCor
Fabiane Kayamori principal investigator
Heart Institute - InCor
Geraldo Lorenzi-Filho, MD, PhD principal investigator
Heart Institute - InCor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oropharyngeal exercises and Respiratory exercises, nasal dilator, nasal lavage in people with Primary Snore, Obstructive Sleep Apnea (Mild and Moderate)., run by University of Sao Paulo 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 28 May 2014. 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. Some participants in this study may receive a placebo. 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 Geraldo Lorenzi-Filho, MD, PhD (55-XX-11-26615486, geraldo.lorenzi@incor.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper airway collapsability (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01636856, which also lists 1 linked publication.
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 28 May 2014.