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

Not Applicable

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

• Registration Number: NCT01636856
• Lead Sponsor: University of Sao Paulo

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.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-07-05
• Study First Submitted QC: 2012-07-05
• Study First Posted: 2012-07-10
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-27
• Last Update Posted: 2014-05-28
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Snore	3 months
Images from magnetic resonance	3 months
Negative expiratory pressure	3 months
Upper airway collapsability	3 months

Secondary Outcome Measures

Name	Time	Method
Sleep related questionnaires	3 months

Trial Locations

Locations (1)

Incor- Heart Institute, Sleep Laboratory; 🇧🇷 São Paulo, Brazil