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

This study is currently recruiting participants.
Verified July 2012 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Geraldo Lorenzi-Filho, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01636856
First received: July 5, 2012
Last updated: NA
Last verified: July 2012
History: No changes posted
  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 wash. 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 Ressonance, 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 wash

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 COLAPSABILITY OF UPPER AIRWAYS AWAKE AND ASLEEP IN PATIENTS WITH PRIMARY SNORING AND MILD TO MODERATE OBSTRUCTIVE SLEEP APNEA

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Upper airway colapsability [ 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: January 2014
Estimated Primary Completion Date: December 2013 (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 wash
 Behavioral: Respiratory exercises, nasal dilator, nasal wash
Respiratory exercises, nasal dilator, nasal wash

  Eligibility

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

Inclusion Criteria:

sujects with primary snore, mild and moderate obstructive sleep apnea

Exclusion Criteria:

BMI > or = 40, craniofacial malformations, smokers, pregnat 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
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
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: July 5, 2012
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
Snoring
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Respiratory Sounds

ClinicalTrials.gov processed this record on May 16, 2013