Efficiency of Speech Therapy in Resistant Hypertensive Patients With Mild Obstructive Sleep Apnea Syndrome

Universidade Federal do Rio de Janeiro

Status: Unknown

Conditions: Hypertension Secondary; Sleep Apnea, Obstructive

Treatments: Other: Control; Other: Speech therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03753633

62061716.1.0000.5257

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Speech therapy Group

Experimental group

Description:

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.

Treatment:

Other: Speech therapy

Control Group

Sham Comparator group

Description:

25 patients will perform inspiratory and expiratory exercises recruiting diaphragmatic muscle.

Treatment:

Other: Control