AzTrials
AzTrials

Obstructive Sleep ApneaNCT03788668

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

A study testing Hyoid suspension in people with Obstructive Sleep Apnea, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Obstructive Sleep Apnea
What is being tested?
Hyoid suspension
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
31 participants
Where
1 siteEgypt
Study dates
1 Apr 2019to 1 Jun 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Assiut University Hospital

    Asyut, 71516

    Ahmed Saleh, MSc, 002010071787377, ahmed.saleh3@med.au.edu.eg

Other trials in Egypt

About this study

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

Read the detailed description

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.

Being tested
Hyoid suspension
Keywords
Hyoid suspension, Barbed reposition pharyngoplasty
Medical subject headings
Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hyoid suspensionProcedure or surgery

    Hyoid suspension will be done with barbed reposition pharyngoplasty

Study groups in NCT03788668
Study groupRoleWhat they receive
Hyoid suspension with barbed reposition pharyngoplastyActive comparatorNot described
Receives: Procedure: Hyoid suspension
barbed reposition pharyngoplastyNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 4 months after intervention

  2. lowest O2 saturation index (LSO2)

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

    Measured: 4 months after intervention

  3. mean O2 saturation

    Increase this parameter indicate better outcome

    Measured: 4 months after intervention

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

    Decrease in this parameter indicate better outcome

    Measured: 4 months after intervention

  5. 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

    Measured: 4 months after intervention

Secondary outcomes (1)
  1. Day time sleepiness will be assessed using Epworth sleepiness score (ESS)

    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

    Measured: 4 months after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2018
  2. Study start1 Apr 2019 (estimated)
  3. Primary completion31 Dec 2020 (estimated)
  4. Study completion1 Jun 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Investigator
Enrolment
31 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03788668
Sponsor's protocol ID
Hyoid suspension & BRP in OSA
Status last verified
Feb 2019
First submitted
26 Dec 2018
Last updated
26 Feb 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Hyoid suspension in people with Obstructive Sleep Apnea, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ahmed Saleh, MSc (00201007178377, ahmed.saleh3@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Apnea hypopnea index (AHI) (time frame: 4 months after intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in