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Role of Hyoid Suspension With Barbed Reposition Pharyngoplasty in Management of Lateral Pharyngeal Wall Collapse in Obstructive Sleep Apnea Patients

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ClinicalTrials.gov Identifier: NCT03788668
Recruitment Status : Not yet recruiting
First Posted : December 27, 2018
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmed Ezzat Mohamed Saleh, Assiut University

Brief Summary:

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


Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Procedure: Hyoid suspension Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Primary Purpose: Treatment
Official Title: Role of Hyoid Suspension With Barbed Reposition Pharyngoplasty in Management of Lateral Pharyngeal Wall Collapse in Obstructive Sleep Apnea Patients
Estimated Study Start Date : April 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Active Comparator: Hyoid suspension with barbed reposition pharyngoplasty Procedure: Hyoid suspension
Hyoid suspension will be done with barbed reposition pharyngoplasty

No Intervention: barbed reposition pharyngoplasty



Primary Outcome Measures :
  1. Apnea hypopnea index (AHI) [ Time Frame: 4 months after intervention ]

    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


  2. lowest O2 saturation index (LSO2) [ Time Frame: 4 months after intervention ]
    Lowest 02 saturation during sleep Increase of this parameter indicate better outcome

  3. mean O2 saturation [ Time Frame: 4 months after intervention ]
    Increase this parameter indicate better outcome

  4. percentage of sleep time with O2 saturation below 90% (CT90%) [ Time Frame: 4 months after intervention ]
    Decrease in this parameter indicate better outcome

  5. Degree of airway obstruction with Drug Induced Sleep Endoscopy (DISE) [ Time Frame: 4 months after intervention ]
    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


Secondary Outcome Measures :
  1. Day time sleepiness will be assessed using Epworth sleepiness score (ESS) [ Time Frame: 4 months after intervention ]

    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

    1. slight chance of dozing
    2. moderate chance of dozing
    3. 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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult patients of both sexes between 18-60 years old.
  2. Moderate to severe obstructive sleep apnea diagnosed by sleep study with apnea hypopnea index (AHI) > 15/h.
  3. Body mass index (BMI) <35.
  4. Refusing or intolerable to use continuous positive airway pressure.
  5. Lateral pharyngeal wall collapse diagnosed by drug induced sleep endoscopy.
  6. Patients who underwent previous tonsillectomy, adenoidectomy or previous nasal surgeries can be included.

Exclusion Criteria:

  1. Patients who are unfit for surgeries.
  2. Patients who are tolerable to continuous positive airway pressure.
  3. Patients who underwent any palatal, pharyngeal, oral, mandibular, maxillofacial surgeries.
  4. Patients with central sleep apnea and neurological syndromes.
  5. Patients with neck, cervical vertebral pathologies and hypothyroidism.
  6. Patients who had facial skeletal abnormalities.
  7. Patients who had kissing tonsils or adenoids or huge tongue base.
  8. Patients who have other level of obstruction (beside oropharyngeal lateral wall collapse and hypopharyngeal retro lingual obstruction) will be excluded or have this level of obstruction completely managed before recruitment in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03788668


Contacts
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Contact: Ahmed Saleh, MSc 00201007178377 ahmed.saleh3@med.au.edu.eg

Locations
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Egypt
Assiut University Hospital Recruiting
Assiut, Egypt, 71516
Contact: Ahmed Saleh, MSc    002010071787377    ahmed.saleh3@med.au.edu.eg   
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Ahmed Saleh, MSc Otorhinolaryngology Specialist Assiut University Hospital

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Responsible Party: Ahmed Ezzat Mohamed Saleh, Otorhinolaryngology Specialist, Assiut University
ClinicalTrials.gov Identifier: NCT03788668     History of Changes
Other Study ID Numbers: Hyoid suspension & BRP in OSA
First Posted: December 27, 2018    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ahmed Ezzat Mohamed Saleh, Assiut University:
Hyoid suspension
Barbed reposition pharyngoplasty
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases