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

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

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01636856
• Other study ID #: 3604/11/022
• Status: Recruiting
• Phase: N/A
• First received: July 5, 2012
• Last updated: May 27, 2014
• Start date: December 2011
• Est. completion date: December 2015

Study information

• Verified date: May 2014
• Source: University of Sao Paulo
• Contact: Geraldo Lorenzi-Filho, MD, PhD
• Phone: 55-XX-11-26615486
• Email: geraldo.lorenzi[@]incor.usp.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Oropharyngeal exercises
Oropharyngeal exercises (derived from speech language pathology) to the soft palate, tongue and facial muscles exercises as well as stomatognathic functions.
• Respiratory exercises, nasal dilator, nasal lavage
Respiratory exercises, nasal dilator, nasal lavage

Locations

Country	Name	City	State
Brazil	Incor- Heart Institute, Sleep Laboratory	São Paulo

Sponsors (3)

Lead Sponsor	Collaborator
University of Sao Paulo	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Upper airway collapsability		3 months	Yes
Primary	Images from magnetic resonance		3 months	Yes
Primary	Negative expiratory pressure		3 months	Yes
Primary	Snore		3 months	Yes
Secondary	Sleep related questionnaires		3 months	Yes