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

NCT03788668 | Unknown

• 1 other identifier: Hyoid suspension & BRP in OSA
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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

Conditions

Obstructive Sleep Apnea

Keywords

Hyoid suspension; Barbed reposition pharyngoplasty

Outcome Measures

Primary Outcomes (5)

• Apnea hypopnea index (AHI)

  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

  4 months after intervention

• lowest O2 saturation index (LSO2)

  Lowest 02 saturation during sleep Increase of this parameter indicate better outcome

  4 months after intervention

• mean O2 saturation

  Increase this parameter indicate better outcome

  4 months after intervention

• percentage of sleep time with O2 saturation below 90% (CT90%)

  Decrease in this parameter indicate better outcome

  4 months after intervention

• Degree of airway obstruction with Drug Induced Sleep Endoscopy (DISE)

  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

  4 months after intervention

Secondary Outcomes (1)

• Day time sleepiness will be assessed using Epworth sleepiness score (ESS)

  4 months after intervention

Study Arms (2)

Hyoid suspension with barbed reposition pharyngoplasty

ACTIVE COMPARATOR

Procedure: Hyoid suspension

barbed reposition pharyngoplasty

NO INTERVENTION

Interventions

Hyoid suspension PROCEDURE

Hyoid suspension will be done with barbed reposition pharyngoplasty

Hyoid suspension with barbed reposition pharyngoplasty

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Patients who are unfit for surgeries.
• Patients who are tolerable to continuous positive airway pressure.
• Patients who underwent any palatal, pharyngeal, oral, mandibular, maxillofacial surgeries.
• Patients with central sleep apnea and neurological syndromes.
• Patients with neck, cervical vertebral pathologies and hypothyroidism.
• Patients who had facial skeletal abnormalities.
• Patients who had kissing tonsils or adenoids or huge tongue base.
• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, 71516, Egypt

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Ahmed Saleh, MSc

  Otorhinolaryngology Specialist Assiut University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Saleh, MSc

CONTACT

00201007178377; ahmed.saleh3@med.au.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Otorhinolaryngology Specialist

Study Record Dates

• First Submitted: December 26, 2018
• First Posted: December 27, 2018
• Study Start: April 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: June 1, 2021
• Last Updated: February 26, 2019

Record last verified: 2019-02

Locations

EG (1)