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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01636856
Acronym
EOE
Enrollment
40
Registered
2012-07-10
Start date
2011-12-31
Completion date
2015-12-31
Last updated
2014-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

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

BEHAVIORALRespiratory exercises, nasal dilator, nasal lavage

Respiratory exercises, nasal dilator, nasal lavage

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo
CollaboratorOTHER_GOV
Conselho Nacional de Desenvolvimento Científico e Tecnológico
CollaboratorOTHER_GOV
University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Snore3 months
Upper airway collapsability3 months
Images from magnetic resonance3 months
Negative expiratory pressure3 months

Secondary

MeasureTime frame
Sleep related questionnaires3 months

Countries

Brazil

Contacts

Primary ContactGeraldo Lorenzi-Filho, MD, PhD
geraldo.lorenzi@incor.usp.br55-XX-11-26615486

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026