Clinical trial NCT03753633: Efficiency of Speech Therapy in Resistant Hypertensive Patients With Mild Obstructive Sleep Apnea Syndrome
Official title: Efficiency of Speech Therapy in Resistant Hypertensive Patients With Mild Obstructive Sleep Apnea Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Apnea, Obstructive
Hypertension Secondary
Keywords: speech therapy
sleep apnea
resistant hypertension
quality of life
quality of sleep
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

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

Primary outcomes:
measure: Changes in Epworth sleepiness scale
timeFrame: Five months
measure: Changes in SF-36
timeFrame: Five months
measure: Changes in Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Five months
Secondary outcomes:
measure: Apnea-hypopnea index
timeFrame: Three months after Clinical evaluation initial
measure: Qualitative assessment of Speech Therapy Assessment
timeFrame: Four months
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitário Clementino Fraga Filho
Study officials:
affiliation: Universidade Federal do Rio de Janeiro
name: Alessandra B de Sousa
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal do Rio de Janeiro
name: Mariana P Brendim, Master
role: STUDY_CHAIR
affiliation: Universidade Federal do Rio de Janeiro
name: Elizabeth S Muxfeldt
role: STUDY_DIRECTOR
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