NCT03753633

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Universidade Federal do Rio de Janeiro · Academic / Other
• Sex: All
• Age: 30 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sleep Apnea, Obstructive
• Hypertension Secondary

Interventions

Type	Name	Description
OTHER	Speech therapy	Oropharyngeal exercises will be performed under the supervision of a speech therapist.
OTHER	Control	Inspiratory and expiratory exercises recruiting diaphragmatic muscles

Timeline

• Start date: 2017-10-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2018-11-27
• Last updated: 2018-11-27

Locations

1 site across 1 country: Brazil