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

U

University of Sao Paulo

Status

Unknown

Conditions

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

Treatments

Behavioral: Oropharyngeal exercises
Behavioral: Respiratory exercises, nasal dilator, nasal lavage

Study type

Interventional

Funder types

Other

Identifiers

NCT01636856
3604/11/022

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

25 to 65 years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

1
Active Comparator group
Description:
Oropharyngeal exercises and oropharyngeal functions
Treatment:
Behavioral: Oropharyngeal exercises
2
Sham Comparator group
Description:
Nasal dilator, respiratory exercise, nasal lavage
Treatment:
Behavioral: Respiratory exercises, nasal dilator, nasal lavage

Trial contacts and locations

1

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Central trial contact

Geraldo Lorenzi-Filho, MD, PhD

Data sourced from clinicaltrials.gov

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