Phonoaudiologic Therapy Adjunct to Treatment on Patients With Obstructive Sleep Apnea
Primary Purpose
Obstructive Sleep Apnea Syndrome
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Continuous Positive Airway Pressure (CPAP)
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea Syndrome focused on measuring obstructive sleep apnea, oropharyngeal exercises, speech therapy
Eligibility Criteria
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
Sites / Locations
- Associação Fundo de Incentivo a Psicofarmacologia
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
placebo exercices
phonoaudiologic therapy
Arm Description
relaxation exercises and stretching neck, without therapeutic purpose.
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.
Outcomes
Primary Outcome Measures
objective sleep pattern
sleep stages, arousals, apnea-hypopnea index, oxyhemoglobin saturation evaluated by polysomnography
Secondary Outcome Measures
somnolence
score of Epworth Sleepiness Scale
Quality of Life
score of WHOQOL-BREF and FOSQ questionnaires
Cognition
Evaluations of Psychomotor Vigilance Test
Full Information
NCT ID
NCT01289405
First Posted
February 1, 2011
Last Updated
February 5, 2014
Sponsor
Associação Fundo de Incentivo à Pesquisa
1. Study Identification
Unique Protocol Identification Number
NCT01289405
Brief Title
Phonoaudiologic Therapy Adjunct to Treatment on Patients With Obstructive Sleep Apnea
Official Title
Phonoaudiologic Therapy as an Adjunct to the Continuous Positive Airway Pressure Treatment on Patients With Obstructive Sleep Apnea Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Associação Fundo de Incentivo à Pesquisa
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome
Keywords
obstructive sleep apnea, oropharyngeal exercises, speech therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo exercices
Arm Type
Placebo Comparator
Arm Description
relaxation exercises and stretching neck, without therapeutic purpose.
Arm Title
phonoaudiologic therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Continuous Positive Airway Pressure (CPAP)
Intervention Description
mechanical splint to open airway during sleep, considered the gold standard treatment for patients with obstructive sleep apnea
Primary Outcome Measure Information:
Title
objective sleep pattern
Description
sleep stages, arousals, apnea-hypopnea index, oxyhemoglobin saturation evaluated by polysomnography
Time Frame
90 days
Secondary Outcome Measure Information:
Title
somnolence
Description
score of Epworth Sleepiness Scale
Time Frame
90 days
Title
Quality of Life
Description
score of WHOQOL-BREF and FOSQ questionnaires
Time Frame
90 days
Title
Cognition
Description
Evaluations of Psychomotor Vigilance Test
Time Frame
90 days
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lia Rita A Bittencourt, MD, PhD
Organizational Affiliation
Universidade Federal de São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Associação Fundo de Incentivo a Psicofarmacologia
City
São Paulo
State/Province
SP
ZIP/Postal Code
04024-002
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
27913971
Citation
Diaferia G, Santos-Silva R, Truksinas E, Haddad FLM, Santos R, Bommarito S, Gregorio LC, Tufik S, Bittencourt L. Myofunctional therapy improves adherence to continuous positive airway pressure treatment. Sleep Breath. 2017 May;21(2):387-395. doi: 10.1007/s11325-016-1429-6. Epub 2016 Dec 2.
Results Reference
derived
Learn more about this trial
Phonoaudiologic Therapy Adjunct to Treatment on Patients With Obstructive Sleep Apnea
We'll reach out to this number within 24 hrs