<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/NCT03788668</url>
  </required_header>
  <id_info>
    <org_study_id>Hyoid suspension &amp; BRP in OSA</org_study_id>
    <nct_id>NCT03788668</nct_id>
  </id_info>
  <brief_title>Role of Hyoid Suspension With Barbed Reposition Pharyngoplasty in Management of Lateral Pharyngeal Wall Collapse in Obstructive Sleep Apnea Patients</brief_title>
  <official_title>Role of Hyoid Suspension With Barbed Reposition Pharyngoplasty in Management of Lateral Pharyngeal Wall Collapse in Obstructive Sleep Apnea Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim of the study&#xD;
&#xD;
      To determine the exact role of hyoid bone suspension surgery in splinting lateral pharyngeal&#xD;
      wall in the era of the lateral pharyngoplasty&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Before recruitment of the patients, they will be subjected to detailed history taking and&#xD;
      full ear nose throat examination. Body mass index and neck circumference will be measured.&#xD;
      All the patients will undergo sleep study and the following parameters will be documented:&#xD;
      Apnea hypopnea index (AHI), lowest O2 saturation index (LSO2), mean O2 saturation and&#xD;
      percentage of sleep time with O2 saturation below 90% (CT90%). Day time sleepiness will be&#xD;
      assessed using Epworth sleepiness score (ESS), we will use the Arabic translated version of&#xD;
      ESS translated and validated after a multicentric study. All the patients will be examined by&#xD;
      flexible fiber optic nasopharyngoscopy to determine the level of obstruction using Muller's&#xD;
      maneuver. All the patients will be subjected to Drug Induced Sleep Endoscopy (DISE) to&#xD;
      confirm the level of obstruction and the surgeon will comment on the lateral wall collapse at&#xD;
      the level of oropharynx and hypopharynx. All the patients will be counseled about the other&#xD;
      options of non-invasive treatment and importance of weight reduction. All the patients will&#xD;
      sign an informed consent.&#xD;
&#xD;
      Surgical techniques:&#xD;
&#xD;
      The first step was bilateral tonsillectomy with identification and meticulous sparing of the&#xD;
      palatoglossus and palatopharyngeus muscles; the most important trick was to spare as much as&#xD;
      possible the mucosal covering of both anterior and posterior pillars. Two weakening or&#xD;
      releasing partial incisions were done by a pinpoint bowie (Colorado) at the inferior (caudal)&#xD;
      part of the palatopharyngeal muscle. A full thickness (mucosa and muscle) triangle was&#xD;
      removed at the superolateral corner of the tonsil to obtain a wider and most squared&#xD;
      oropharyngeal inlet. The center of the palate was marked at palatal spine also the&#xD;
      pterygomandibular raphe in both sides were located by digital palpation and marked. We used a&#xD;
      single barbed suture, bidirectional polydioxanone absorbable monofilament, size 0, with&#xD;
      transition zone in the middle. One needle was introduced at the center point then passed&#xD;
      laterally within the palate, turning around pterygomandibular raphe till it comes out at the&#xD;
      most superior part of the raphe at one side; the thread is pulled until it hangs at the&#xD;
      central transition zone which is a free zone present between the two directions of the&#xD;
      thread. The needle again is re-introduced close to point of exit, passing around the&#xD;
      pterygomandibular raphe, till it comes out into the tonsillectomy bed, then through the upper&#xD;
      part of the palatopharyngeus muscle and comes out near to mucosa of posterior pillar not&#xD;
      through it. The posterior pillar is entered at the junction between the upper third and the&#xD;
      lower two-thirds. Then, again the needle is passed back through the tonsillectomy bed and&#xD;
      then this suture will be suspended around the raphe again; a gentle traction is then applied&#xD;
      on the thread only and no knots are taken. This leads to a stable re-positioning of the&#xD;
      posterior pillar to more lateral and anterior location without any knot, then Marking the&#xD;
      center of palate, pterygomandibular raphe and squaring of anterior pillars. The barbed suture&#xD;
      around the upper part of the right raphe and it hangs at the central transition zone. c The&#xD;
      needle is passed through the upper part of the palatopharyngeus muscle and comes out near to&#xD;
      mucosa of posterior pillar not through it. The needle is passed through the upper pole and&#xD;
      suspended around the raphe, pulling of barbed suture without taking of knots this stitch is&#xD;
      repeated at least three times between raphe and muscle till the lower pole of the muscle is&#xD;
      reached. The opposite side is done by the same way. Finally, each thread comes out at the&#xD;
      raphe of the same side, for locking of the stitches and looseness prevention; a superficial&#xD;
      stitch in the opposite direction is taken, and then the thread is cut while bushing the&#xD;
      tissue downward for more traction.&#xD;
&#xD;
      Hyoid suspension (Thyro-hyoid-pexy) will be done. The hyoid suspension procedure will be&#xD;
      performed under general anesthesia, with the patient in supine position with the neck&#xD;
      extended. Skin marks over the mandibular margin, hyoid bone, thyroid notch and sternal notch.&#xD;
      The skin incision followed a horizontal skin crease between the body of the hyoid bone and&#xD;
      the thyroid notch. The incision will be carefully extended through the subcutaneous tissue&#xD;
      and platysma muscle, as the muscle is less defined in the midline. Upper and lower&#xD;
      subplatysmal flaps will be elevated to expose the strap muscles, which will be separated in&#xD;
      the midline. The plane of the thyroid cartilage and the surface of the hyoid bone will be&#xD;
      exposed and the thyrohyoid membrane was clearly defined. Vicryl 0 will be wrapped around the&#xD;
      body of the hyoid bone on each side of the midline with a sharp needle and then directed to&#xD;
      the thyroid lamina of the same side piercing it from the lateral to the medial surface, about&#xD;
      ½ cm from the upper border of the cartilage. Two sutures will be performed on each side. The&#xD;
      sutures will be tied steadily and gently,with the neck in neutral position. The wound will be&#xD;
      closed in layers. A suction drainage will be placed for 48 hours.&#xD;
&#xD;
      Sample size:&#xD;
&#xD;
      In this prospective study, 31 patients will be included and will be randomized into two&#xD;
      groups. Sample size calculation was done using sample size calculator software on&#xD;
      ww.calculator.net website.&#xD;
&#xD;
      Randomization:&#xD;
&#xD;
      Patients will be randomized in two groups; Group (A) will undergo Barbed Reposition&#xD;
      pharyngoplasty only and group (B) will under go Barbed Reposition pharyngoplasty and hyoid&#xD;
      suspension. Simple randomization will be done by allowing the patients to choose between two&#xD;
      sealed envelope.&#xD;
&#xD;
      Neither the pulmonologist or the phoniatricians or the surgeon who will perform post&#xD;
      operative sleep study, post operative nasopharyngoscopy and post operative sleep endoscopy&#xD;
      will know the type of operation performed to the patients.&#xD;
&#xD;
      Follow up:&#xD;
&#xD;
      Patients will be subjected to another sleep study, flexible fiber optic nasopharyngoscopy,&#xD;
      drug induced sleep endoscopy and day time sleepiness evaluation using (ESS) 4 months after&#xD;
      the surgery.&#xD;
&#xD;
      Statistical analysis:&#xD;
&#xD;
      The data will be tested for normality using the Kolmogorov-Smirnov test and for homogeneity&#xD;
      variances prior to further statistical analysis. Chi-square and fisher exact tests will be&#xD;
      used to compare between categorical variables. Unpaired t-test will be used to compare&#xD;
      between continuous variables for normally distributed data and Mann Whitney U for&#xD;
      non-normally distributed data. A two-tailed p &lt; 0.05 will be considered statistically&#xD;
      significant. All analyses were performed with the International Business Machines Statistical&#xD;
      Package for the Social Sciences International Business Machines 20.0 software.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">April 1, 2019</start_date>
  <completion_date type="Anticipated">June 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 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>Double (Care Provider, Investigator)</masking>
    <masking_description>Neither the pulmonologist or the phoniatracian or the surgeon who will befrom post operative sleep study, post operative nasopharyngoscopy and post operative sleep endoscopy will know the type of operation performed to the patients.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Apnea hypopnea index (AHI)</measure>
    <time_frame>4 months after intervention</time_frame>
    <description>Number of apneas and hypopneas recorded during sleep 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. The apneas (pauses in breathing) must last for at least 10 seconds and be associated with a decrease in blood oxygenation.&#xD;
Minimal: AHI &lt; 5 per hour Mild: AHI ≥ 5, but &lt; 15 per hour Moderate: AHI ≥ 15, but &lt; 30 per hour Severe: AHI ≥ 30 per hour decrease in the AHI indicate better outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>lowest O2 saturation index (LSO2)</measure>
    <time_frame>4 months after intervention</time_frame>
    <description>Lowest 02 saturation during sleep Increase of this parameter indicate better outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>mean O2 saturation</measure>
    <time_frame>4 months after intervention</time_frame>
    <description>Increase this parameter indicate better outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>percentage of sleep time with O2 saturation below 90% (CT90%)</measure>
    <time_frame>4 months after intervention</time_frame>
    <description>Decrease in this parameter indicate better outcome</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Degree of airway obstruction with Drug Induced Sleep Endoscopy (DISE)</measure>
    <time_frame>4 months after intervention</time_frame>
    <description>Degree of obstruction will be evaluated using grading system Grade 1 (0-25%) of airway is obstructed Grade 2 (25-50%) of airway obstructed Grade 3 (50-75%) of airway is obstructed Grade 4 (75-100%) of airway is obstructed Decrease in this parameter indicate better outcome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Day time sleepiness will be assessed using Epworth sleepiness score (ESS)</measure>
    <time_frame>4 months after intervention</time_frame>
    <description>Decrease in this parameter indicate better outcome it is a questionnaire to assess the sleepniess during day time by assessment the chance of dozing during different daily activities it contain 8 question each one will be answered using a scale from 0-3 0= no dozing&#xD;
slight chance of dozing&#xD;
moderate chance of dozing&#xD;
high chance of dozing Total score can range from 0-24 0-5 Lower Normal Daytime Sleepiness 6-10 Higher Normal Daytime Sleepiness 11-12 Mild Excessive Daytime Sleepiness 13-15 Moderate Excessive Daytime Sleepiness 16-24 Severe Excessive Daytime Sleepiness</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">31</enrollment>
  <condition>Obstructive Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>Hyoid suspension with barbed reposition pharyngoplasty</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>barbed reposition pharyngoplasty</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Hyoid suspension</intervention_name>
    <description>Hyoid suspension will be done with barbed reposition pharyngoplasty</description>
    <arm_group_label>Hyoid suspension with barbed reposition pharyngoplasty</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult patients of both sexes between 18-60 years old.&#xD;
&#xD;
          2. Moderate to severe obstructive sleep apnea diagnosed by sleep study with apnea&#xD;
             hypopnea index (AHI) &gt; 15/h.&#xD;
&#xD;
          3. Body mass index (BMI) &lt;35.&#xD;
&#xD;
          4. Refusing or intolerable to use continuous positive airway pressure.&#xD;
&#xD;
          5. Lateral pharyngeal wall collapse diagnosed by drug induced sleep endoscopy.&#xD;
&#xD;
          6. Patients who underwent previous tonsillectomy, adenoidectomy or previous nasal&#xD;
             surgeries can be included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who are unfit for surgeries.&#xD;
&#xD;
          2. Patients who are tolerable to continuous positive airway pressure.&#xD;
&#xD;
          3. Patients who underwent any palatal, pharyngeal, oral, mandibular, maxillofacial&#xD;
             surgeries.&#xD;
&#xD;
          4. Patients with central sleep apnea and neurological syndromes.&#xD;
&#xD;
          5. Patients with neck, cervical vertebral pathologies and hypothyroidism.&#xD;
&#xD;
          6. Patients who had facial skeletal abnormalities.&#xD;
&#xD;
          7. Patients who had kissing tonsils or adenoids or huge tongue base.&#xD;
&#xD;
          8. Patients who have other level of obstruction (beside oropharyngeal lateral wall&#xD;
             collapse and hypopharyngeal retro lingual obstruction) will be excluded or have this&#xD;
             level of obstruction completely managed before recruitment in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed Saleh, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Otorhinolaryngology Specialist Assiut University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ahmed Saleh, MSc</last_name>
    <phone>00201007178377</phone>
    <email>ahmed.saleh3@med.au.edu.eg</email>
  </overall_contact>
  <location>
    <facility>
      <name>Assiut University Hospital</name>
      <address>
        <city>Assiut</city>
        <zip>71516</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <contact>
      <last_name>Ahmed Saleh, MSc</last_name>
      <phone>002010071787377</phone>
      <email>ahmed.saleh3@med.au.edu.eg</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 26, 2018</study_first_submitted>
  <study_first_submitted_qc>December 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 27, 2018</study_first_posted>
  <last_update_submitted>February 25, 2019</last_update_submitted>
  <last_update_submitted_qc>February 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Ahmed Ezzat Mohamed Saleh</investigator_full_name>
    <investigator_title>Otorhinolaryngology Specialist</investigator_title>
  </responsible_party>
  <keyword>Hyoid suspension</keyword>
  <keyword>Barbed reposition pharyngoplasty</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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03788668
org study id: Hyoid suspension & BRP in OSA
nct id: NCT03788668
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Aim of the study

      To determine the exact role of hyoid bone suspension surgery in splinting lateral pharyngeal
      wall in the era of the lateral pharyngoplasty
Before recruitment of the patients, they will be subjected to detailed history taking and
      full ear nose throat examination. Body mass index and neck circumference will be measured.
      All the patients will undergo sleep study and the following parameters will be documented:
      Apnea hypopnea index (AHI), lowest O2 saturation index (LSO2), mean O2 saturation and
      percentage of sleep time with O2 saturation below 90% (CT90%). Day time sleepiness will be
      assessed using Epworth sleepiness score (ESS), we will use the Arabic translated version of
      ESS translated and validated after a multicentric study. All the patients will be examined by
      flexible fiber optic nasopharyngoscopy to determine the level of obstruction using Muller's
      maneuver. All the patients will be subjected to Drug Induced Sleep Endoscopy (DISE) to
      confirm the level of obstruction and the surgeon will comment on the lateral wall collapse at
      the level of oropharynx and hypopharynx. All the patients will be counseled about the other
      options of non-invasive treatment and importance of weight reduction. All the patients will
      sign an informed consent.

      Surgical techniques:

      The first step was bilateral tonsillectomy with identification and meticulous sparing of the
      palatoglossus and palatopharyngeus muscles; the most important trick was to spare as much as
      possible the mucosal covering of both anterior and posterior pillars. Two weakening or
      releasing partial incisions were done by a pinpoint bowie (Colorado) at the inferior (caudal)
      part of the palatopharyngeal muscle. A full thickness (mucosa and muscle) triangle was
      removed at the superolateral corner of the tonsil to obtain a wider and most squared
      oropharyngeal inlet. The center of the palate was marked at palatal spine also the
      pterygomandibular raphe in both sides were located by digital palpation and marked. We used a
      single barbed suture, bidirectional polydioxanone absorbable monofilament, size 0, with
      transition zone in the middle. One needle was introduced at the center point then passed
      laterally within the palate, turning around pterygomandibular raphe till it comes out at the
      most superior part of the raphe at one side; the thread is pulled until it hangs at the
      central transition zone which is a free zone present between the two directions of the
      thread. The needle again is re-introduced close to point of exit, passing around the
      pterygomandibular raphe, till it comes out into the tonsillectomy bed, then through the upper
      part of the palatopharyngeus muscle and comes out near to mucosa of posterior pillar not
      through it. The posterior pillar is entered at the junction between the upper third and the
      lower two-thirds. Then, again the needle is passed back through the tonsillectomy bed and
      then this suture will be suspended around the raphe again; a gentle traction is then applied
      on the thread only and no knots are taken. This leads to a stable re-positioning of the
      posterior pillar to more lateral and anterior location without any knot, then Marking the
      center of palate, pterygomandibular raphe and squaring of anterior pillars. The barbed suture
      around the upper part of the right raphe and it hangs at the central transition zone. c The
      needle is passed through the upper part of the palatopharyngeus muscle and comes out near to
      mucosa of posterior pillar not through it. The needle is passed through the upper pole and
      suspended around the raphe, pulling of barbed suture without taking of knots this stitch is
      repeated at least three times between raphe and muscle till the lower pole of the muscle is
      reached. The opposite side is done by the same way. Finally, each thread comes out at the
      raphe of the same side, for locking of the stitches and looseness prevention; a superficial
      stitch in the opposite direction is taken, and then the thread is cut while bushing the
      tissue downward for more traction.

      Hyoid suspension (Thyro-hyoid-pexy) will be done. The hyoid suspension procedure will be
      performed under general anesthesia, with the patient in supine position with the neck
      extended. Skin marks over the mandibular margin, hyoid bone, thyroid notch and sternal notch.
      The skin incision followed a horizontal skin crease between the body of the hyoid bone and
      the thyroid notch. The incision will be carefully extended through the subcutaneous tissue
      and platysma muscle, as the muscle is less defined in the midline. Upper and lower
      subplatysmal flaps will be elevated to expose the strap muscles, which will be separated in
      the midline. The plane of the thyroid cartilage and the surface of the hyoid bone will be
      exposed and the thyrohyoid membrane was clearly defined. Vicryl 0 will be wrapped around the
      body of the hyoid bone on each side of the midline with a sharp needle and then directed to
      the thyroid lamina of the same side piercing it from the lateral to the medial surface, about
      ½ cm from the upper border of the cartilage. Two sutures will be performed on each side. The
      sutures will be tied steadily and gently,with the neck in neutral position. The wound will be
      closed in layers. A suction drainage will be placed for 48 hours.

      Sample size:

      In this prospective study, 31 patients will be included and will be randomized into two
      groups. Sample size calculation was done using sample size calculator software on
      ww.calculator.net website.

      Randomization:

      Patients will be randomized in two groups; Group (A) will undergo Barbed Reposition
      pharyngoplasty only and group (B) will under go Barbed Reposition pharyngoplasty and hyoid
      suspension. Simple randomization will be done by allowing the patients to choose between two
      sealed envelope.

      Neither the pulmonologist or the phoniatricians or the surgeon who will perform post
      operative sleep study, post operative nasopharyngoscopy and post operative sleep endoscopy
      will know the type of operation performed to the patients.

      Follow up:

      Patients will be subjected to another sleep study, flexible fiber optic nasopharyngoscopy,
      drug induced sleep endoscopy and day time sleepiness evaluation using (ESS) 4 months after
      the surgery.

      Statistical analysis:

      The data will be tested for normality using the Kolmogorov-Smirnov test and for homogeneity
      variances prior to further statistical analysis. Chi-square and fisher exact tests will be
      used to compare between categorical variables. Unpaired t-test will be used to compare
      between continuous variables for normally distributed data and Mann Whitney U for
      non-normally distributed data. A two-tailed p < 0.05 will be considered statistically
      significant. All analyses were performed with the International Business Machines Statistical
      Package for the Social Sciences International Business Machines 20.0 software.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Care Provider, Investigator)
masking description: Neither the pulmonologist or the phoniatracian or the surgeon who will befrom post operative sleep study, post operative nasopharyngoscopy and post operative sleep endoscopy will know the type of operation performed to the patients.
measure: Apnea hypopnea index (AHI)
time frame: 4 months after intervention
description: Number of apneas and hypopneas recorded during sleep 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. The apneas (pauses in breathing) must last for at least 10 seconds and be associated with a decrease in blood oxygenation.
Minimal: AHI < 5 per hour Mild: AHI ≥ 5, but < 15 per hour Moderate: AHI ≥ 15, but < 30 per hour Severe: AHI ≥ 30 per hour decrease in the AHI indicate better outcome
measure: lowest O2 saturation index (LSO2)
time frame: 4 months after intervention
description: Lowest 02 saturation during sleep Increase of this parameter indicate better outcome
measure: mean O2 saturation
time frame: 4 months after intervention
description: Increase this parameter indicate better outcome
measure: percentage of sleep time with O2 saturation below 90% (CT90%)
time frame: 4 months after intervention
description: Decrease in this parameter indicate better outcome
measure: Degree of airway obstruction with Drug Induced Sleep Endoscopy (DISE)
time frame: 4 months after intervention
description: Degree of obstruction will be evaluated using grading system Grade 1 (0-25%) of airway is obstructed Grade 2 (25-50%) of airway obstructed Grade 3 (50-75%) of airway is obstructed Grade 4 (75-100%) of airway is obstructed Decrease in this parameter indicate better outcome
measure: Day time sleepiness will be assessed using Epworth sleepiness score (ESS)
time frame: 4 months after intervention
description: Decrease in this parameter indicate better outcome it is a questionnaire to assess the sleepniess during day time by assessment the chance of dozing during different daily activities it contain 8 question each one will be answered using a scale from 0-3 0= no dozing
slight chance of dozing
moderate chance of dozing
high chance of dozing Total score can range from 0-24 0-5 Lower Normal Daytime Sleepiness 6-10 Higher Normal Daytime Sleepiness 11-12 Mild Excessive Daytime Sleepiness 13-15 Moderate Excessive Daytime Sleepiness 16-24 Severe Excessive Daytime Sleepiness
arm group label: Hyoid suspension with barbed reposition pharyngoplasty
arm group type: Active Comparator
arm group label: barbed reposition pharyngoplasty
arm group type: No Intervention
intervention type: Procedure
intervention name: Hyoid suspension
description: Hyoid suspension will be done with barbed reposition pharyngoplasty
arm group label: Hyoid suspension with barbed reposition pharyngoplasty
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Ahmed Saleh, MSc
role: Principal Investigator
affiliation: Otorhinolaryngology Specialist Assiut University Hospital
last name: Ahmed Saleh, MSc
phone: 00201007178377
email: ahmed.saleh3@med.au.edu.eg
facility: 
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Ahmed Ezzat Mohamed Saleh
investigator title: Otorhinolaryngology Specialist
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
sharing ipd: Undecided