Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 2:01 AM
Study NCT ID:
NCT01289405
Status:
COMPLETED
Last Update Posted:
2014-02-06
First Post:
2011-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phonoaudiologic Therapy Adjunct to Treatment on Patients With Obstructive Sleep Apnea
Sponsor:
Associação Fundo de Incentivo à Pesquisa
Organization:
Study Overview
Official Title:
Phonoaudiologic Therapy as an Adjunct to the Continuous Positive Airway Pressure Treatment on Patients With Obstructive Sleep Apnea Syndrome
Status:
COMPLETED
Status Verified Date:
2014-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: