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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by University of Sao Paulo
Sponsor:
Collaborators:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Geraldo Lorenzi-Filho, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01636856
First received: July 5, 2012
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Primary Snore, Obstructive Sleep Apnea (Mild and Moderate).
Behavioral: Oropharyngeal exercises
Behavioral: Respiratory exercises, nasal dilator, nasal lavage

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

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Upper airway collapsability [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Images from magnetic resonance [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Negative expiratory pressure [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Snore [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Sleep related questionnaires [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: December 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Oropharyngeal exercises and oropharyngeal functions
Behavioral: Oropharyngeal exercises
Oropharyngeal exercises (derived from speech language pathology) to the soft palate, tongue and facial muscles exercises as well as stomatognathic functions.
Sham Comparator: 2
Nasal dilator, respiratory exercise, nasal lavage
Behavioral: Respiratory exercises, nasal dilator, nasal lavage
Respiratory exercises, nasal dilator, nasal lavage

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.

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01636856

Contacts
Contact: Geraldo Lorenzi-Filho, MD, PhD 55-XX-11-26615486 geraldo.lorenzi@incor.usp.br

Locations
Brazil
Incor- Heart Institute, Sleep Laboratory Recruiting
São Paulo, Brazil, 05403-904
Contact: Geraldo Lorenzi-Filho, MD, PhD    55 (0xx) 11- 2661-5486    geraldo.lorenzi@gmail.com   
Sub-Investigator: Pedro Rodrigues Genta, MD, PhD         
Sub-Investigator: Fabiane Kayamori         
Sub-Investigator: Vanessa Ieto         
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Principal Investigator: Vanessa Ieto Heart Institute - InCor
Principal Investigator: Fabiane Kayamori Heart Institute - InCor
Principal Investigator: Geraldo Lorenzi-Filho, MD, PhD Heart Institute - InCor
  More Information

No publications provided

Responsible Party: Geraldo Lorenzi-Filho, Associated Professor of Pulmonary Division, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01636856     History of Changes
Other Study ID Numbers: 3604/11/022
Study First Received: July 5, 2012
Last Updated: May 27, 2014
Health Authority: Brazil: Ethics Committee

Keywords provided by University of Sao Paulo:
oropharyngeal exercises, obstructive sleep apnea, speech therapy, magnetic resonance, PCRIT, negative expiratory pressure, snore

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on October 20, 2014