Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phonoaudiologic Therapy as an Adjunct to the Continuous Positive Airway Pressure Treatment on Patients With Obstructive Sleep Apnea Syndrome
Brief Summary: Objective: to evaluate the effects of a speech therapy exercises program in the treatment of Obstructive Sleep Apna Syndrome (OSAS) patients based on the clinical and polysomnography (PSG) parameters.

Methods: 80 patients with OSAS will be evaluated: men, 25-65 years old, body mass index \< 35 kg/m2 and scores of Epworth Sleepiness Scale \> 9. Patients will be divided into four groups: I: 20 patients with OSAS underwent speech therapy; II: 20 patients with OSAS underwent placebo therapy of Speech Therapy; III: 20 patients starting treatment with CPAP underwent speech therapy; IV: 20 patients starting treatment with CPAP without speech therapy or placebo. The speech therapy include isometric and isotonic exercises to improve posture, mobility and muscle tone of the soft palate, pharyngeal constrictor muscles, tip and base of tongue, cheeks and lips. Placebo therapy includes relaxation exercises and stretching neck, without therapeutic purpose. Both therapies are applied for three months, three times a day, lasting 20 minutes each session. During the treatment, the subjects will be monitored in weekly meetings, for orientation and description of the exercises and return of the fulfilled exercises diary. The subjects will also be followed at the CPAP clinic in returns after one week, a month and at the end of the study. Conduct assessments before and after treatment and after twenty one days washout, including: assessing the upper airway, anthropometric investigation of the facial skeleton and speech of Orofacial, questionnaires (Epworth Sleepiness Scale, FOSQ, General Segment and use of CPAP, WHOQOL-BREF, snoring), Psychomotor Vigilance Test and PSG.


Options:
A: Inclusion Criteria:

* referred to the FMC Sleep Centre for assessment of SDB
* meet one of the three criteria for suspected severe SDB:

  1. Respiratory disturbance index (RDI) \>/= 30 events/hour on an ambulatory sleep test
  2. Mean nocturnal oxygen saturation \</= 85% on an ambulatory sleep test
  3. Suspected hypoventilation, defined by an RDI \>/= 15 events/hour on an ambulatory sleep test and partial pressure of carbon dioxide \>/= 45 mmHg on arterial blood gas
  4. On supplemental oxygen therapy with high suspicion of SDB (as determined by physician review of referral)

Exclusion Criteria:

* Suspected concomitant sleep disorder other than SDB
* A previous diagnosis of OSA treated with PAP or dental appliance
* Primary health insurance provided by a province other than Alberta
* Failure to provide consent to participate in the study
* Under the age of 18
B: Inclusion Criteria:

* Age 21 - 75
* Diagnosis of OSAHS with baseline AHI (Apnea-Hypopnea Index) equal or greater than 15 events/hr of sleep
* Able and willing to provide written informed consent
* Agreement to try PAP (positive airway pressure) as initial treatment approach
* Adequate clinical CPAP titration within two weeks of enrollment

Exclusion Criteria:

* Participation in another interventional research study within the last 30 days
* The need for more than one titration PSG (polysomnography)
* The use of sedatives or hypnotics during the titration PSG
* Major medical or psychiatric condition that would interfere with the demands of the study, adherence to PAP or the ability to commit to follow-up assessment.
* Prior prescription for, or exposure to PAP therapy within the previous year (except exposure to CPAP during clinical therapy titration.)
* Chronic respiratory failure or insufficiency with suspected or known neuromuscular disease, moderate or severe COPD (chronic obstructive pulmonary disease) or other pulmonary disorders, or any condition with an elevation of arterial carbon dioxide levels (\>45 mmHG) while awake or participants qualifying for oxygen therapy (arterial saturation \< or equal to 88% for more than five minutes).
* Surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days
* Surgery at any time for the treatment of OSAHS such as uvulopalatopharyngoplasty (UPPP)
* Presence of untreated or poorly managed, non-OSAHS related sleep disorders:

  * moderate to severe periodic limb movements (greater or equal to 15 per hour with symptoms or arousals)
  * Restless Leg syndrome (greater than 10 per hour)
  * Males experiencing chronic insomnia
* Use of medications with hypnotic or sedative effects or regular use of night time sedatives or sleeping aids greater than or equal to one night per week.
* Consumption of ethanol more than 4 nights per week (CAGE criteria)
* Shift workers
C: Inclusion Criteria:

Individuals willing to participate must meet the following eligibility criteria prior to enrollment:

* Patients referred for a sleep evaluation for suspected sleep apnea.
* Age 18 years or older
* Living within 90 miles of the Sleep Center.

Exclusion Criteria:

Individuals will be excluded from the study for the following reasons:

* Unable or unwilling to provide informed written consent.
* Lack of telephone access or inability to return for follow-up testing.
* A history of prior sleep evaluations, OSA treatment, or sleep disorder in addition to OSA.
* A clinically unstable chronic medical condition as defined by a new diagnosis or change in medical management in the previous 3 months of cardiac disease, thyroid disease, diabetes, depression or psychosis, cirrhosis, or recently diagnosed cancer.
* Individuals already on long term oxygen therapy or requiring bilevel positive airway pressure.
* Individuals with rotating shift work or irregular work schedules over the last 6 months.
* Suspected or confirmed to be pregnant. A pregnancy test will be performed using the urine sample obtained at the initial visit.
* Inability to complete the Assessment Battery - e.g. less than a 5th grade reading level
D: Inclusion Criteria:

* Patients with a recent diagnosis of OSAS
* Body mass index (BMI) \< 35 kg/m2

Exclusion Criteria:

* Facial malformations
* Regular use of hypnotic medications
* Hypothyroidism
* Previous stroke
* Neuromuscular disease
* Heart failure
* Coronary disease
* Severe obstructive nasal disease

Answer: D