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Effects of OroPharyngeal Exercises on Patients With Moderate Obstructive Sleep Apnea

This study has been completed.
Sponsor:
Collaborators:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00660777
First received: April 7, 2008
Last updated: April 15, 2008
Last verified: April 2008
History of Changes
  Purpose

Background: Upper airway muscle weakness plays an important role in the genesis of obstructive sleep apnea (OSA). Oropharyngeal exercises are derived from speech therapy consisting of isometric and isotonic exercises directed to tongue, soft palate and lateral pharyngeal wall. We hypothesized that oropharyngeal exercises will attenuate OSA severity.

We will include 30 moderate OSA patients (apnea-hypopnea index (AHI), between 15 and 30 events/hour) that will randomize to 3 months of general measurements and daily nasal lavage (n=15, control) or daily oropharyngeal exercises (~30 min) plus nasal lavage (n=16). Full polysomnography, anthropometric measurements, questionnaires derived from Berlin, Epworth and Pittsburgh evaluating quantitatively (range) snoring frequency (0-4) and intensity (1-3), daytime sleepiness (0-24) and sleep quality (0-21), respectively will be performed at baseline and study end.


Condition Intervention Phase
Obstructive Sleep Apnea
 Behavioral: Deep breathing, bilateral alternate chewing, nasal lavage
Behavioral: Oropharyngeal exercises
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effects of OroPharyngeal Exercises on Patients With Moderate Obstructive Sleep Apnea: A Randomized, Controlled Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Apnea-hypopnea index [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

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

Enrollment: 30
Study Start Date: February 2004
Study Completion Date: April 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: 1
Control Group
 Behavioral: Deep breathing, bilateral alternate chewing, nasal lavage
Deep breathing, bilateral alternate chewing, nasal lavage
Active Comparator: 2
Therapy Group
 Behavioral: Oropharyngeal exercises
Oropharyngeal exercises (derived from speech language pathology) to the soft palate, tongue and facial muscles exercises as well as stomatognathic functions.

Detailed Description:

Patients: Eligible patients aged between 25 e 65 years old with a recent diagnosis of moderate OSA evaluated in the sleep laboratory, Pulmonary Division, Heart Institute (InCor). We will exclude patients with one or more of the follow conditions: body mass index (BMI) >40 kg/m2; facial malformations; regular use of hypnotic medications, hypothyroidism, previous stroke, neuromuscular disease, heart failure, coronary disease, and severe obstructive nasal disease.

Polysomnography: All patients will be evaluated by full polysomnography. The person who analyzed the sleep study will be blind to the group allocation.

Questionnaire: We will employ questionnaires previously validated and used in Brazil: Snoring frequency (derived from the Berlin questionnaire); subjective daytime sleepiness (Epworth questionnaire); quality of sleep (Pittsburgh sleep quality questionnaire).

Control Group: Sham therapy will consisted of a weekly supervised section (~30 min) of deep breathing, through the nose, while sitting, followed by a practice of bilateral alternate chewing. The patients will be instructed to perform the same procedure at home once a day (30 min), plus alternate bilateral chewing and nasal lavage with application of 10 ml of saline in each nostril three times a day.

Study Group: The same schedule and set of instructions will be applied to the control group was given to these patients. Oropharyngeal exercises are derived from speech language pathology and include soft palate, tongue and facial muscles exercises as well as stomatognathic function exercises.

Experimental Design: After fulfilling entry criteria, the patients will be randomized for 3 months of control or treatment group, with oropharyngeal exercises. All patients will be evaluated by the speech language pathologist once a week for 30 minutes. Patients that failed to return for 3 consecutive weeks or failed to comply to the exercises schedule at home were excluded from the study. Polysomnography and questionnaires will be performed at the beginning and at the end of the study.

Primary outcome: Apnea-hypopnea index.

Secondary outcomes: Lowest oxygen saturation and sleep related questionnaires.

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged between 25 and 65 years old with a recent diagnosis of moderate obstructive sleep apnea

Exclusion Criteria:

  • Body mass index (BMI) >40 kg/m2
  • Facial malformations
  • Regular use of hypnotic medications
  • Hypothyroidism
  • Previous stroke
  • Neuromuscular disease
  • Heart failure
  • Coronary disease
  • Severe obstructive nasal disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00660777

Locations
Brazil
Heart Institute (InCor)
Sao Paulo, Brazil, 05403-904
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: Kátia Guimaraes Heart Institute (InCor)
Principal Investigator: Geraldo Lorenzi-Filho, MD, PhD Heart Institute (InCor)
  More Information

No publications provided by University of Sao Paulo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Geraldo Lorenzi-Filho, Heart Institute (InCor) - University of Sao Paulo Medical School
ClinicalTrials.gov Identifier: NCT00660777     History of Changes
Other Study ID Numbers: OPE-OSA
Study First Received: April 7, 2008
Last Updated: April 15, 2008
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
oropharyngeal exercises
obstructive sleep apnea
speech therapy

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

ClinicalTrials.gov processed this record on May 19, 2013