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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Oropharyngeal exercises and oropharyngeal functions

Group Type ACTIVE_COMPARATOR

Oropharyngeal exercises

Intervention Type BEHAVIORAL

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

2

Nasal dilator, respiratory exercise, nasal lavage

Group Type SHAM_COMPARATOR

Respiratory exercises, nasal dilator, nasal lavage

Intervention Type BEHAVIORAL

Respiratory exercises, nasal dilator, nasal lavage

Interventions

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Oropharyngeal exercises

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

Intervention Type BEHAVIORAL

Respiratory exercises, nasal dilator, nasal lavage

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes