Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado de São Paulo | OTHER_GOV |
| Conselho Nacional de Desenvolvimento CientÃfico e Tecnológico | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Oropharyngeal exercises and oropharyngeal functions |
|
| 2 | Sham Comparator | Nasal dilator, respiratory exercise, nasal lavage |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oropharyngeal exercises | Behavioral | Oropharyngeal exercises (derived from speech language pathology) to the soft palate, tongue and facial muscles exercises as well as stomatognathic functions. |
| Measure | Description | Time Frame |
|---|---|---|
| Upper airway collapsability | 3 months | |
| Images from magnetic resonance | 3 months | |
| Negative expiratory pressure | 3 months | |
| Snore | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep related questionnaires | 3 months |
Not provided
Inclusion Criteria:
subjects with primary snore, mild and moderate obstructive sleep apnea
Exclusion Criteria:
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.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Geraldo Lorenzi-Filho, MD, PhD | Contact | 55-XX-11-26615486 | geraldo.lorenzi@incor.usp.br |
| Name | Affiliation | Role |
|---|---|---|
| Vanessa Ieto | Heart Institute - InCor | Principal Investigator |
| Fabiane Kayamori | Heart Institute - InCor | Principal Investigator |
| Geraldo Lorenzi-Filho, MD, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Incor- Heart Institute, Sleep Laboratory | Recruiting | São Paulo | São Paulo | 05403-904 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25950418 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D008224 | Lymphoma, Follicular |
| D003147 | Communication Disorders |
| D012913 | Snoring |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D055556 | Nasal Lavage |
| ID | Term |
|---|---|
| D007507 | Therapeutic Irrigation |
| D008919 | Investigative Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Respiratory exercises, nasal dilator, nasal lavage | Behavioral | Respiratory exercises, nasal dilator, nasal lavage |
|
| Heart Institute - InCor |
| Principal Investigator |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D012135 | Respiratory Sounds |
| D012818 | Signs and Symptoms, Respiratory |