<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03753633</url>
  </required_header>
  <id_info>
    <org_study_id>62061716.1.0000.5257</org_study_id>
    <nct_id>NCT03753633</nct_id>
  </id_info>
  <brief_title>Efficiency of Speech Therapy in Resistant Hypertensive Patients With Mild Obstructive Sleep Apnea Syndrome</brief_title>
  <official_title>Efficiency of Speech Therapy in Resistant Hypertensive Patients With Mild Obstructive Sleep Apnea Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal do Rio de Janeiro</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal do Rio de Janeiro</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to analyze the effect of speech therapy on quality of life,&#xD;
      sleep quality, daytime sleepiness level and apnea-hypopnea index in patients with&#xD;
      hypertensive patients with mild obstructive apnea syndrome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The database will include demographic characteristics, cardiovascular risk factors and and&#xD;
      target-organ damages. Anthropometric measurements (height, weight, and abdominal and neck&#xD;
      circumference) will be registered. Daytime sleepiness, quality of sleep and quality of life&#xD;
      wiill be evaluated through the respective questionnaires: Epworth sleepiness scale,&#xD;
      Pittsburgh Sleep Quality Index (PSQI) and SF-36. In order to evaluate the airway, the&#xD;
      Mallampati grade will be used in addition to the adapted assessment protocol from Guimarães&#xD;
      (2009). The differences between the final score and the baseline score will be calculated and&#xD;
      adjusted by the baseline value found in each of the questionnaires applied. Finally, the&#xD;
      analysis excluding the patients with suboptimal adherence to speech therapy treatment (less&#xD;
      than 85%) compared to the control group will be redone. If there are benefits of treatment&#xD;
      with speech therapy, it will also be offered to the control group after the end of the&#xD;
      clinical trial. Statistical analysis will be done in the statistical package SPSS version&#xD;
      19.0 package (SPSS Inc. Chicago, Illinois, USA). Data obtained may be of benefit to future&#xD;
      patients and will be used only for statistical purposes. The confidentiality of the&#xD;
      information collected will be guaranteed, thus ensuring the privacy and confidentiality of&#xD;
      the information. In addition, the data obtained will not be used for other purposes not&#xD;
      foreseen in the protocol.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">October 1, 2017</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Epworth sleepiness scale</measure>
    <time_frame>Five months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in SF-36</measure>
    <time_frame>Five months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Pittsburgh Sleep Quality Index (PSQI)</measure>
    <time_frame>Five months</time_frame>
    <description>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 &quot;bons dormidores&quot; e &quot;maus dormidores&quot;. 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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Apnea-hypopnea index</measure>
    <time_frame>Three months after Clinical evaluation initial</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Qualitative assessment of Speech Therapy Assessment</measure>
    <time_frame>Four months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Sleep Apnea, Obstructive</condition>
  <condition>Hypertension Secondary</condition>
  <arm_group>
    <arm_group_label>Speech therapy Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>25 patients will perform inspiratory and expiratory exercises recruiting diaphragmatic muscle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Speech therapy</intervention_name>
    <description>Oropharyngeal exercises will be performed under the supervision of a speech therapist.</description>
    <arm_group_label>Speech therapy Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>Inspiratory and expiratory exercises recruiting diaphragmatic muscles</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients in follow-up in the Hypertension Program (ProHart) at Hospital Universitário&#xD;
             Clementino Fraga Filho - UFRJ at least six months;&#xD;
&#xD;
          -  Patient with Resistant Hypertension and Mild Obstructive Sleep Apnea detected by&#xD;
             polysomnography;&#xD;
&#xD;
          -  All participants that give written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age&gt; 85 years;&#xD;
&#xD;
          -  Cognitive deficit that prevents speech therapy;&#xD;
&#xD;
          -  Severe clinical events in the last 6 months;&#xD;
&#xD;
          -  Refusal of the patient to participate in the study;&#xD;
&#xD;
          -  Pregnancy;&#xD;
&#xD;
          -  Prior and regular use of CPAP;&#xD;
&#xD;
          -  Clinical data suggestive of neurological disease with cognitive and / or motor&#xD;
             sequelae, craniofacial malformation, severe upper airway obstruction, Neuromuscular&#xD;
             disease, users of hypnotic drugs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alessandra B de Sousa</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade Federal do Rio de Janeiro</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mariana P Brendim, Master</last_name>
    <role>Study Chair</role>
    <affiliation>Universidade Federal do Rio de Janeiro</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Elizabeth S Muxfeldt</last_name>
    <role>Study Director</role>
    <affiliation>Universidade Federal do Rio de Janeiro</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Universitário Clementino Fraga Filho</name>
      <address>
        <city>Rio de Janeiro</city>
        <zip>21941-913</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
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  <verification_date>November 2018</verification_date>
  <study_first_submitted>January 26, 2017</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>November 21, 2018</last_update_submitted>
  <last_update_submitted_qc>November 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal do Rio de Janeiro</investigator_affiliation>
    <investigator_full_name>Alessandra Bastos de Sousa</investigator_full_name>
    <investigator_title>Master student</investigator_title>
  </responsible_party>
  <keyword>speech therapy</keyword>
  <keyword>sleep apnea</keyword>
  <keyword>resistant hypertension</keyword>
  <keyword>quality of life</keyword>
  <keyword>quality of sleep</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apnea</mesh_term>
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
    <mesh_term>Communication Disorders</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03753633
org study id: 62061716.1.0000.5257
nct id: NCT03753633
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Changes in Epworth sleepiness scale
time frame: Five months
description: 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.
measure: Changes in SF-36
time frame: Five months
description: 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.
measure: Changes in Pittsburgh Sleep Quality Index (PSQI)
time frame: Five months
description: 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.
measure: Apnea-hypopnea index
time frame: Three months after Clinical evaluation initial
description: 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.
measure: Qualitative assessment of Speech Therapy Assessment
time frame: Four months
description: 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.
arm group label: Speech therapy Group
arm group type: Experimental
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.
arm group label: Control Group
arm group type: Sham Comparator
description: 25 patients will perform inspiratory and expiratory exercises recruiting diaphragmatic muscle.
intervention type: Other
intervention name: Speech therapy
description: Oropharyngeal exercises will be performed under the supervision of a speech therapist.
arm group label: Speech therapy Group
intervention type: Other
intervention name: Control
description: Inspiratory and expiratory exercises recruiting diaphragmatic muscles
arm group label: Control Group
criteria: 
gender: All
minimum age: 30 Years
maximum age: 85 Years
healthy volunteers: No
last name: Alessandra B de Sousa
role: Principal Investigator
affiliation: Universidade Federal do Rio de Janeiro
last name: Mariana P Brendim, Master
role: Study Chair
affiliation: Universidade Federal do Rio de Janeiro
last name: Elizabeth S Muxfeldt
role: Study Director
affiliation: Universidade Federal do Rio de Janeiro
facility: 
country: Brazil
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responsible party type: Principal Investigator
investigator affiliation: Universidade Federal do Rio de Janeiro
investigator full name: Alessandra Bastos de Sousa
investigator title: Master student
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
mesh term: Communication Disorders
mesh term: Hypertension
sharing ipd: No