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Phonoaudiologic Therapy Adjunct to Treatment on Patients With Obstructive Sleep Apnea

Phonoaudiologic Therapy as an Adjunct to the Continuous Positive Airway Pressure Treatment on Patients With Obstructive Sleep Apnea Syndrome

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01289405
Enrollment
80
Registered
2011-02-03
Start date
2010-10-31
Completion date
Unknown
Last updated
2014-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

obstructive sleep apnea, oropharyngeal exercises, speech therapy

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.

Interventions

DEVICEContinuous Positive Airway Pressure (CPAP)

mechanical splint to open airway during sleep, considered the gold standard treatment for patients with obstructive sleep apnea

Sponsors

Associação Fundo de Incentivo à Pesquisa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
25 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
objective sleep pattern90 dayssleep stages, arousals, apnea-hypopnea index, oxyhemoglobin saturation evaluated by polysomnography

Secondary

MeasureTime frameDescription
somnolence90 daysscore of Epworth Sleepiness Scale
Quality of Life90 daysscore of WHOQOL-BREF and FOSQ questionnaires
Cognition90 daysEvaluations of Psychomotor Vigilance Test

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 11, 2026