Effects of OroPharyngeal Exercises on Patients With Moderate Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

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.
    

Intervention name(s): Deep breathing, bilateral alternate chewing, nasal lavage; Oropharyngeal exercises
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Deep breathing, bilateral alternate chewing, nasal lavage; Oropharyngeal exercises (derived from speech language pathology) to the soft palate, tongue and facial muscles exercises as well as stomatognathic functions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: oropharyngeal exercises; obstructive sleep apnea; speech therapy