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

November 21, 2018 updated by: Alessandra Bastos de Sousa, Universidade Federal do Rio de Janeiro
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 21941-913
        • Hospital Universitario Clementino Fraga Filho

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Speech therapy
Oropharyngeal exercises will be performed under the supervision of a speech therapist.
Sham Comparator: Control Group
25 patients will perform inspiratory and expiratory exercises recruiting diaphragmatic muscle.
Other: Control
Inspiratory and expiratory exercises recruiting diaphragmatic muscles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Epworth sleepiness scale
Time Frame: Five months
Changes found in score after 12 weeks in control group and speech therapy group. The ESS measures EDS levels, assigning a score (from 0 to 3) according to the possibility of sleeping in each mentioned situation. A score from 0 to 6 is considered normal; from 7 to 9, limitrophe; 10 to 14, mild sleepiness; 15 to 20, moderate sleepiness; and above, severe sleepiness. Values ≥11 are generally associated with sleep disorders.
Five months
Changes in SF-36
Time Frame: Five months
Changes found in score after 12 weeks in control group and speech therapy group. The SF-36 consisting of 36 items grouped into eight domains: functional capacity, physical aspects, pain, general health status, vitality, social aspects, emotional aspects and mental health. It assesses both negative (illness or disease) and positive aspects (well-being), with a score from 0 to 100, with zero being the worst health condition and 100 being the best, with each dimension being analyzed separately.
Five months
Changes in Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Five months
Changes found in score after 12 weeks in control group and speech therapy group. O questionário de Pittsburgh permite avaliar o sono de forma qualitativa e quantitativa, de forma padronizada, ao determinar os "bons dormidores" e "maus dormidores". O questionário avalia parâmetros quantitativos, tais como a duração do sono, latência do sono e número de despertares; e parâmetros qualitativos, que são puramente subjetivos.
Five months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apnea-hypopnea index
Time Frame: Three months after Clinical evaluation initial
The patients were submitted to polysomnography using BrainNet BNT Polipolygraph, supervised by a qualified professional. Electroencephalogram, electrooculogram, submental electromyogram, nasal airflow, oximetry, respiratory effort, electrocardiogram and anterior tibial electromyogram were realized. The exam was complemented with video monitoring. Patients who had less than 240 minutes of sleep in the night were excluded.The report was prepared by a qualified medical professional, Sleep Medicine specialist and with a practice certificate in the area, who was unaware of the patients; clinical data, according to the norms established in the American Academy of Sleep Medicine manual.
Three months after Clinical evaluation initial
Qualitative assessment of Speech Therapy Assessment
Time Frame: Four months
Changes in Orofacial Myofunctional after speech therapy in therapy group and after 12 weeks after the evaluation initial in control group. Data were collected from the oromiofunctional speech-language assessment protocol, with face evaluation (eyes, nostrils, lips, cheeks, jaw, tongue and palate) and functions (breath, chew and speech). The UAW physical status, evaluated through the modified Mallampati classification, checks according to the spatial relationship between the soft palate and the body of tongue with the pharynx posterior wall and the narrowing of veil and hypopharynx( class 1, the entire palatopharyngeal veil and uvula are visualized; class 2, uvula and palatopharyngeal veil arches partially visualized; class 3, uvula or palatopharyngeal veil not visualized; class 4, all soft palate not visualized). The anthropometric measurements: height and weight to calculate BMI, neck circumference(greater than 41 cm - women - and 43 cm - men) and waist circumference.
Four months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal do Rio de Janeiro

Investigators

  • Principal Investigator: Alessandra B de Sousa, Universidade Federal do Rio de Janeiro
  • Study Chair: Mariana P Brendim, Master, Universidade Federal do Rio de Janeiro
  • Study Director: Elizabeth S Muxfeldt, Universidade Federal do Rio de Janeiro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2017

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

January 26, 2017

First Submitted That Met QC Criteria

November 21, 2018

First Posted (Actual)

November 27, 2018

Study Record Updates

Last Update Posted (Actual)

November 27, 2018

Last Update Submitted That Met QC Criteria

November 21, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 62061716.1.0000.5257

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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