Efficiency of Speech Therapy in Resistant Hypertensive Patients With Mild Obstructive Sleep Apnea Syndrome
NCT ID: NCT03753633
Last Updated: 2018-11-27
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
50 participants
Study Classification
INTERVENTIONAL
Study Start Date
2017-10-01
Study Completion Date
2019-12-31
Brief Summary
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The purpose of this study is to analyze the effect of speech therapy on quality of life, sleep quality, daytime sleepiness level and apnea-hypopnea index in patients with hypertensive patients with mild obstructive apnea syndrome.
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Detailed Description
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The database will include demographic characteristics, cardiovascular risk factors and and target-organ damages. Anthropometric measurements (height, weight, and abdominal and neck circumference) will be registered. Daytime sleepiness, quality of sleep and quality of life wiill be evaluated through the respective questionnaires: Epworth sleepiness scale, Pittsburgh Sleep Quality Index (PSQI) and SF-36. In order to evaluate the airway, the Mallampati grade will be used in addition to the adapted assessment protocol from Guimarães (2009). The differences between the final score and the baseline score will be calculated and adjusted by the baseline value found in each of the questionnaires applied. Finally, the analysis excluding the patients with suboptimal adherence to speech therapy treatment (less than 85%) compared to the control group will be redone. If there are benefits of treatment with speech therapy, it will also be offered to the control group after the end of the clinical trial. Statistical analysis will be done in the statistical package SPSS version 19.0 package (SPSS Inc. Chicago, Illinois, USA). Data obtained may be of benefit to future patients and will be used only for statistical purposes. The confidentiality of the information collected will be guaranteed, thus ensuring the privacy and confidentiality of the information. In addition, the data obtained will not be used for other purposes not foreseen in the protocol.
Conditions
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Sleep Apnea, Obstructive
Hypertension Secondary
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
FACTORIAL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Investigators
Outcome Assessors
Study Groups
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Speech therapy Group
25 patients will be treated with speech therapy, once a week, during 40 minutes for 12 weeks. Oropharyngeal exercises will be performed under the supervision of a speech therapist. Patients will perform the oropharyngeal exercises at home every day.
Group Type
EXPERIMENTAL
Speech therapy
Intervention Type
OTHER
Oropharyngeal exercises will be performed under the supervision of a speech therapist.
Control Group
25 patients will perform inspiratory and expiratory exercises recruiting diaphragmatic muscle.
Group Type
SHAM_COMPARATOR
Control
Intervention Type
OTHER
Inspiratory and expiratory exercises recruiting diaphragmatic muscles
Interventions
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Speech therapy
Oropharyngeal exercises will be performed under the supervision of a speech therapist.
Intervention Type
OTHER
Control
Inspiratory and expiratory exercises recruiting diaphragmatic muscles
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* Patients in follow-up in the Hypertension Program (ProHart) at Hospital Universitário Clementino Fraga Filho - UFRJ at least six months;
* Patient with Resistant Hypertension and Mild Obstructive Sleep Apnea detected by polysomnography;
* All participants that give written informed consent.
* Patient with Resistant Hypertension and Mild Obstructive Sleep Apnea detected by polysomnography;
* All participants that give written informed consent.
Exclusion Criteria
* Age\> 85 years;
* Cognitive deficit that prevents speech therapy;
* Severe clinical events in the last 6 months;
* Refusal of the patient to participate in the study;
* Pregnancy;
* Prior and regular use of CPAP;
* Clinical data suggestive of neurological disease with cognitive and / or motor sequelae, craniofacial malformation, severe upper airway obstruction, Neuromuscular disease, users of hypnotic drugs
* Cognitive deficit that prevents speech therapy;
* Severe clinical events in the last 6 months;
* Refusal of the patient to participate in the study;
* Pregnancy;
* Prior and regular use of CPAP;
* Clinical data suggestive of neurological disease with cognitive and / or motor sequelae, craniofacial malformation, severe upper airway obstruction, Neuromuscular disease, users of hypnotic drugs
Minimum Eligible Age
30 Years
Maximum Eligible Age
85 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Universidade Federal do Rio de Janeiro
OTHER
Sponsor Role
lead
Responsible Party
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Alessandra Bastos de Sousa
Master student
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Alessandra B de Sousa
Role: PRINCIPAL_INVESTIGATOR
Universidade Federal do Rio de Janeiro
Mariana P Brendim, Master
Role: STUDY_CHAIR
Universidade Federal do Rio de Janeiro
Elizabeth S Muxfeldt
Role: STUDY_DIRECTOR
Universidade Federal do Rio de Janeiro
Locations
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Hospital Universitário Clementino Fraga Filho
Rio de Janeiro, , Brazil
Site Status
Countries
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Brazil
References
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Other Identifiers
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62061716.1.0000.5257
Identifier Type: -
Identifier Source: org_study_id
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PHASE3
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Controlled Exercises Effectiveness in Patients With Sleep Apnea
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UNKNOWN
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Clinical Application of Ultrasound in Obstructive Sleep Apnea
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Management of Patients With Suspected of Sleep Apnea-hypopnea Syndrome From Primary Care
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COMPLETED
NA