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Effects of Oropharyngeal Exercises on Patients With Primary Snore, Mild and Moderate Obstructive (EOE)

Primary Purpose

Primary Snore, Obstructive Sleep Apnea (Mild and Moderate).

Status

Unknown status

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Oropharyngeal exercises

Respiratory exercises, nasal dilator, nasal lavage

About this trial

This is an interventional treatment trial for Primary Snore, Obstructive Sleep Apnea (Mild and Moderate). focused on measuring oropharyngeal exercises, obstructive sleep apnea, speech therapy, magnetic resonance, PCRIT, negative expiratory pressure, snore

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Incor- Heart Institute, Sleep LaboratoryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Arm Description

Oropharyngeal exercises and oropharyngeal functions

Nasal dilator, respiratory exercise, nasal lavage

Outcomes

Primary Outcome Measures

Upper airway collapsability

Images from magnetic resonance

Negative expiratory pressure

Snore

Secondary Outcome Measures

Sleep related questionnaires

Full Information

NCT ID

NCT01636856

First Posted

July 5, 2012

Last Updated

May 27, 2014

Sponsor

University of Sao Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico

1. Study Identification

Unique Protocol Identification Number

NCT01636856

Brief Title

Effects of Oropharyngeal Exercises on Patients With Primary Snore, Mild and Moderate Obstructive

Acronym

EOE

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Unknown status

Study Start Date

December 2011 (undefined)

Primary Completion Date

December 2015 (Anticipated)

Study Completion Date

December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Sao Paulo

Collaborators

Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Snore, Obstructive Sleep Apnea (Mild and Moderate).

Keywords

oropharyngeal exercises, obstructive sleep apnea, speech therapy, magnetic resonance, PCRIT, negative expiratory pressure, snore

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Oropharyngeal exercises and oropharyngeal functions

Arm Title

Arm Type

Sham Comparator

Arm Description

Nasal dilator, respiratory exercise, nasal lavage

Intervention Type

Behavioral

Intervention Name(s)

Oropharyngeal exercises

Intervention Description

Oropharyngeal exercises (derived from speech language pathology) to the soft palate, tongue and facial muscles exercises as well as stomatognathic functions.

Intervention Type

Behavioral

Intervention Name(s)

Respiratory exercises, nasal dilator, nasal lavage

Intervention Description

Respiratory exercises, nasal dilator, nasal lavage

Primary Outcome Measure Information:

Title

Upper airway collapsability

Time Frame

3 months

Title

Images from magnetic resonance

Time Frame

3 months

Title

Negative expiratory pressure

Time Frame

3 months

Title

Snore

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Sleep related questionnaires

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Geraldo Lorenzi-Filho, MD, PhD

Phone

55-XX-11-26615486

geraldo.lorenzi@incor.usp.br

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vanessa Ieto

Organizational Affiliation

Heart Institute - InCor

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Fabiane Kayamori

Organizational Affiliation

Heart Institute - InCor

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Geraldo Lorenzi-Filho, MD, PhD

Organizational Affiliation

Heart Institute - InCor

Official's Role

Principal Investigator

Facility Information:

Facility Name

Incor- Heart Institute, Sleep Laboratory

City

São Paulo

ZIP/Postal Code

05403-904

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Geraldo Lorenzi-Filho, MD, PhD

Phone

55 (0xx) 11- 2661-5486

geraldo.lorenzi@gmail.com

First Name & Middle Initial & Last Name & Degree

Pedro Rodrigues Genta, MD, PhD

First Name & Middle Initial & Last Name & Degree

Fabiane Kayamori

First Name & Middle Initial & Last Name & Degree

Vanessa Ieto

12. IPD Sharing Statement

Citations:

PubMed Identifier

25950418

Citation

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.

Results Reference

derived

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Effects of Oropharyngeal Exercises on Patients With Primary Snore, Mild and Moderate Obstructive

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