<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/NCT04412941</url>
  </required_header>
  <id_info>
    <org_study_id>1837-28.06.2019</org_study_id>
    <nct_id>NCT04412941</nct_id>
  </id_info>
  <brief_title>Respiratory Rehabilitation in Obstructive Sleep Apneas</brief_title>
  <acronym>OSA20</acronym>
  <official_title>Myofascial Technique Combined With Myofunctional Exercises In Mild Obstructive Sleep Apnea-Hypopneas Syndrome: A Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Università degli Studi 'G. d'Annunzio' Chieti e Pescara</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>S. Spirito Hospital, Pescara, Italy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Università degli Studi 'G. d'Annunzio' Chieti e Pescara</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 Obstructive Sleep Apnea is characterized by obstruction of the upper airway during sleep&#xD;
      (for at least 10 sec), with repeated breathing pauses, accompanied by oxygen desaturation in&#xD;
      the blood and by sleep interruption with repeated arousals.&#xD;
&#xD;
      The investigators hypothesized that good sleep hygiene, the execution of respiratory&#xD;
      rehabilitation exercises, with specific myofascial exercises on the muscles that are&#xD;
      compromised in the Obstructive Sleep Apnea, can improve the patient's clinical outcome and&#xD;
      quality of life.&#xD;
&#xD;
      The objective of this study is to evaluate the effect of respiratory rehabilitation with&#xD;
      myo-functional exercises in mild obstructive sleep.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients: Eligible patients aged between 40 and 80 years old, with BMI &lt; 30 and with a recent&#xD;
      diagnosis of mild Obstructive Sleep Apnea evaluated with home night cardio-respiratory&#xD;
      monitoring.&#xD;
&#xD;
      The investigators will exclude patients with one or more of the following conditions:&#xD;
      subjects who regularly use hypnoinductive drugs, with craniofacial malformations, who have&#xD;
      suffered recent facial trauma, suffering from hypothyroidism, suffering from neuromuscular&#xD;
      diseases, with recent strokes, severe obstructive nasal disease, systemic infectious diseases&#xD;
      and neoplastic diseases.&#xD;
&#xD;
      Home night cardio-respiratory monitoring: all patients will be evaluated according to&#xD;
      international guidelines (AAMS American Academy Sleep Medicine) with an instrument equipped&#xD;
      with sensors for detection oral/nasal flow, snoring, chest/abdomen movements, pulse oximetry&#xD;
      and heart rate.&#xD;
&#xD;
      Questionnaire: The investigators will employ questionnaires validated in Italy: Snoring&#xD;
      frequency (derived from the Berlin questionnaire); subjective daytime sleepiness (Epworth&#xD;
      questionnaire); quality of sleep (Pittsburgh sleep quality questionnaire).&#xD;
&#xD;
      Patients will be randomized into two groups randomly with a 1: 1 ratio: group 1 (treated&#xD;
      group) or group 2 (control group) for a total of 20 patients per group (according to the&#xD;
      sample size calculation reported in the protocol).&#xD;
&#xD;
      The treatment group will be subjected to an integrated rehabilitation protocol, composed of&#xD;
      Respiratory rehabilitation exercises with diaphragmatic breathing, thoracic mobilization&#xD;
      exercises and manual pompage techniques, followed by manual trigger point therapy techniques,&#xD;
      (that were identified by palpation following the guidelines provided by Travell and Simons&#xD;
      trigger point manual), the accessory inspiratory muscles like pectoralis minor muscle,&#xD;
      scapula elevator muscle, Sternocleidomastoid muscle. The integrated rehabilitation protocol&#xD;
      will be 45 minutes, 3 weekly sessions for 4 weeks, for a total of 12 consecutive sessions.&#xD;
      Also, at every patient will be taught oropharyngeal exercises to perform at home twice a day&#xD;
      (the duration of 15 minutes each session) involving in particular exercises for soft palate,&#xD;
      tongue, facial and genio-glosso muscle.&#xD;
&#xD;
      Both in the treated group and the control group will be given a booklet with the rules for&#xD;
      proper sleep hygiene because sleep is influenced by our lifestyle and various environmental&#xD;
      factors can affect the quality of night sleep.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 22, 2020</start_date>
  <completion_date type="Actual">January 31, 2021</completion_date>
  <primary_completion_date type="Actual">November 30, 2020</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in apnea/hypopnea index (AHI)</measure>
    <time_frame>4 months</time_frame>
    <description>AHI is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sleep questionnaires, Berlin Questionnaire</measure>
    <time_frame>4 months</time_frame>
    <description>it consists of 3 categories related to the risk of sleep apnea (1-severity of snoring, 2- excessive daytime sleepiness, 3-history of obesity or high blood pressure). Depending on the answers and therefore the reported symptoms, it allows a subdivision in high risk or low risk of having apneas;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sleep questionnaires, Epworth Sleepiness Scale</measure>
    <time_frame>4 months</time_frame>
    <description>it is a scale intended to measure daytime sleepiness with a short questionnaire; the answers range from normal (0) to intense (3) in eight different situations; a total score greater than 10 is considered excessive daytime sleepiness</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sleep questionnaires, Pittsburgh Sleep Quality Index</measure>
    <time_frame>4 months</time_frame>
    <description>It is a self-administered questionnaire that assesses sleep quality over a 1-month time interval. Evaluate seven sleep items on a scale of 0 to 3, 0 indicating no difficulty and 3 indicating severe difficulty. The results are expressed in an overall score (between 0 and 21). Values above 5 are consistent with poor sleep quality.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Sleep Disorder</condition>
  <condition>Sleep Apnea Syndromes</condition>
  <arm_group>
    <arm_group_label>Treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Myofunctional exercises + home oropharyngeal exercises + the rules of sleep hygiene</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>the rules of sleep hygiene</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Myofunctional exercises</intervention_name>
    <description>Myofunctional exercises: Respiratory rehabilitation exercises with diaphragmatic breathing, thoracic mobilization exercises and manual pompage techniques, followed by manual trigger point therapy techniques, that were identified by palpation following the guidelines provided by Travell and Simons trigger point manual, the accessory inspiratory muscles like pectoralis minor muscle, scapula elevator muscle, Sternocleidomastoid muscle.&#xD;
Home oropharyngeal exercises: at every patient will be taught oropharyngeal exercises to perform at home twice a day (the duration of 15 minutes each session) involving in particular exercises for soft palate, tongue, facial and genio-glosso muscle.&#xD;
The rules of sleep hygiene: a list of behaviours that physiologically promote a good night's sleep.</description>
    <arm_group_label>Treatment group</arm_group_label>
    <other_name>home oropharyngeal exercises</other_name>
    <other_name>the rules of sleep hygiene</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>The rules of sleep hygiene</intervention_name>
    <description>The rules of sleep hygiene: a list of behaviours that physiologically promote a good night's sleep.</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Treatment group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of mild Obstructive Sleep Apnea (5≤AHI≤14)&#xD;
&#xD;
          -  age between 40 and 80 years&#xD;
&#xD;
          -  BMI &lt;30.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  regular use of Hypno-inducing drugs,&#xD;
&#xD;
          -  severe nasal obstructive disease,&#xD;
&#xD;
          -  primary pulmonary pathology,&#xD;
&#xD;
          -  craniofacial malformations,&#xD;
&#xD;
          -  recent facial traumas,&#xD;
&#xD;
          -  hypothyroidism,&#xD;
&#xD;
          -  neuromuscular diseases,&#xD;
&#xD;
          -  recent stroke,&#xD;
&#xD;
          -  systemic infectious diseases,&#xD;
&#xD;
          -  neoplastic diseases.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Teresa Paolucci, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University G.d'annunzio - Chieti Pescara</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Teresa Paolucci</name>
      <address>
        <city>Chieti</city>
        <state>Abruzzo</state>
        <zip>66100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>October 4, 2021</last_update_submitted>
  <last_update_submitted_qc>October 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Università degli Studi 'G. d'Annunzio' Chieti e Pescara</investigator_affiliation>
    <investigator_full_name>Paolucci Teresa</investigator_full_name>
    <investigator_title>Principal Investigator; Research fellow</investigator_title>
  </responsible_party>
  <keyword>Rehabilitation</keyword>
  <keyword>sleep obstructive apnea</keyword>
  <keyword>oropharyngeal exercises</keyword>
  <keyword>myofunctional exercises</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>Sleep Wake Disorders</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is not a plan to make IPD available, because we didn't get organized</ipd_description>
  </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/NCT04412941
org study id: 1837-28.06.2019
nct id: NCT04412941
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The Obstructive Sleep Apnea is characterized by obstruction of the upper airway during sleep
      (for at least 10 sec), with repeated breathing pauses, accompanied by oxygen desaturation in
      the blood and by sleep interruption with repeated arousals.

      The investigators hypothesized that good sleep hygiene, the execution of respiratory
      rehabilitation exercises, with specific myofascial exercises on the muscles that are
      compromised in the Obstructive Sleep Apnea, can improve the patient's clinical outcome and
      quality of life.

      The objective of this study is to evaluate the effect of respiratory rehabilitation with
      myo-functional exercises in mild obstructive sleep.
Patients: Eligible patients aged between 40 and 80 years old, with BMI < 30 and with a recent
      diagnosis of mild Obstructive Sleep Apnea evaluated with home night cardio-respiratory
      monitoring.

      The investigators will exclude patients with one or more of the following conditions:
      subjects who regularly use hypnoinductive drugs, with craniofacial malformations, who have
      suffered recent facial trauma, suffering from hypothyroidism, suffering from neuromuscular
      diseases, with recent strokes, severe obstructive nasal disease, systemic infectious diseases
      and neoplastic diseases.

      Home night cardio-respiratory monitoring: all patients will be evaluated according to
      international guidelines (AAMS American Academy Sleep Medicine) with an instrument equipped
      with sensors for detection oral/nasal flow, snoring, chest/abdomen movements, pulse oximetry
      and heart rate.

      Questionnaire: The investigators will employ questionnaires validated in Italy: Snoring
      frequency (derived from the Berlin questionnaire); subjective daytime sleepiness (Epworth
      questionnaire); quality of sleep (Pittsburgh sleep quality questionnaire).

      Patients will be randomized into two groups randomly with a 1: 1 ratio: group 1 (treated
      group) or group 2 (control group) for a total of 20 patients per group (according to the
      sample size calculation reported in the protocol).

      The treatment group will be subjected to an integrated rehabilitation protocol, composed of
      Respiratory rehabilitation exercises with diaphragmatic breathing, thoracic mobilization
      exercises and manual pompage techniques, followed by manual trigger point therapy techniques,
      (that were identified by palpation following the guidelines provided by Travell and Simons
      trigger point manual), the accessory inspiratory muscles like pectoralis minor muscle,
      scapula elevator muscle, Sternocleidomastoid muscle. The integrated rehabilitation protocol
      will be 45 minutes, 3 weekly sessions for 4 weeks, for a total of 12 consecutive sessions.
      Also, at every patient will be taught oropharyngeal exercises to perform at home twice a day
      (the duration of 15 minutes each session) involving in particular exercises for soft palate,
      tongue, facial and genio-glosso muscle.

      Both in the treated group and the control group will be given a booklet with the rules for
      proper sleep hygiene because sleep is influenced by our lifestyle and various environmental
      factors can affect the quality of night sleep.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change From Baseline in apnea/hypopnea index (AHI)
time frame: 4 months
description: AHI is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep.
measure: Sleep questionnaires, Berlin Questionnaire
time frame: 4 months
description: it consists of 3 categories related to the risk of sleep apnea (1-severity of snoring, 2- excessive daytime sleepiness, 3-history of obesity or high blood pressure). Depending on the answers and therefore the reported symptoms, it allows a subdivision in high risk or low risk of having apneas;
measure: Sleep questionnaires, Epworth Sleepiness Scale
time frame: 4 months
description: it is a scale intended to measure daytime sleepiness with a short questionnaire; the answers range from normal (0) to intense (3) in eight different situations; a total score greater than 10 is considered excessive daytime sleepiness
measure: Sleep questionnaires, Pittsburgh Sleep Quality Index
time frame: 4 months
description: It is a self-administered questionnaire that assesses sleep quality over a 1-month time interval. Evaluate seven sleep items on a scale of 0 to 3, 0 indicating no difficulty and 3 indicating severe difficulty. The results are expressed in an overall score (between 0 and 21). Values above 5 are consistent with poor sleep quality.
arm group label: Treatment group
arm group type: Experimental
description: Myofunctional exercises + home oropharyngeal exercises + the rules of sleep hygiene
arm group label: Control group
arm group type: Active Comparator
description: the rules of sleep hygiene
intervention type: Behavioral
intervention name: Myofunctional exercises
description: Myofunctional exercises: Respiratory rehabilitation exercises with diaphragmatic breathing, thoracic mobilization exercises and manual pompage techniques, followed by manual trigger point therapy techniques, that were identified by palpation following the guidelines provided by Travell and Simons trigger point manual, the accessory inspiratory muscles like pectoralis minor muscle, scapula elevator muscle, Sternocleidomastoid muscle.
Home oropharyngeal exercises: at every patient will be taught oropharyngeal exercises to perform at home twice a day (the duration of 15 minutes each session) involving in particular exercises for soft palate, tongue, facial and genio-glosso muscle.
The rules of sleep hygiene: a list of behaviours that physiologically promote a good night's sleep.
arm group label: Treatment group
other name: home oropharyngeal exercises
other name: the rules of sleep hygiene
intervention type: Behavioral
intervention name: The rules of sleep hygiene
description: The rules of sleep hygiene: a list of behaviours that physiologically promote a good night's sleep.
arm group label: Control group
arm group label: Treatment group
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: Teresa Paolucci, MD, PhD
role: Principal Investigator
affiliation: University G.d'annunzio - Chieti Pescara
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Università degli Studi 'G. d'Annunzio' Chieti e Pescara
investigator full name: Paolucci Teresa
investigator title: Principal Investigator; Research fellow
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
mesh term: Sleep Wake Disorders
mesh term: Syndrome
sharing ipd: No
ipd description: There is not a plan to make IPD available, because we didn't get organized