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.
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
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.
- Conditions
- Obstructive Sleep Apnea
- 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 group | Role | What they receive |
|---|---|---|
| Hyoid suspension with barbed reposition pharyngoplasty | Active comparator | Not described Receives: Procedure: Hyoid suspension |
| barbed reposition pharyngoplasty | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
lowest O2 saturation index (LSO2)
Lowest 02 saturation during sleep Increase of this parameter indicate better outcome
Measured: 4 months after intervention
mean O2 saturation
Increase this parameter indicate better outcome
Measured: 4 months after intervention
percentage of sleep time with O2 saturation below 90% (CT90%)
Decrease in this parameter indicate better outcome
Measured: 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
Measured: 4 months after intervention
Secondary outcomes (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
- 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
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.
- First posted27 Dec 2018
- Study start1 Apr 2019 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ezzat Mohamed Saleh, Assiut University
- Investigators
- Ahmed Saleh, MSc, Principal investigator, Otorhinolaryngology Specialist Assiut University Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Hyoid Suspension With Barbed Reposition Pharyngoplasty in Management of Lateral Pharyngeal Wall Collapse in Obstructive Sleep Apnea Patients
- ClinicalTrials.gov ID
- NCT03788668
- Acronym / sponsor ID
- Hyoid suspension & BRP in OSA
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Hyoid suspension, Barbed reposition pharyngoplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 27 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyoid suspension with barbed reposition pharyngoplasty | Active comparator | Procedure: Hyoid suspension |
| barbed reposition pharyngoplasty | No intervention | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyoid suspensionHyoid suspension will be done with barbed reposition pharyngoplasty | Procedure or surgery | Hyoid suspension with barbed reposition pharyngoplasty |
Primary outcome
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
lowest O2 saturation index (LSO2)
Time frame: 4 months after intervention
Lowest 02 saturation during sleep Increase of this parameter indicate better outcome
mean O2 saturation
Time frame: 4 months after intervention
Increase this parameter indicate better outcome
percentage of sleep time with O2 saturation below 90% (CT90%)
Time frame: 4 months after intervention
Decrease in this parameter indicate better outcome
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
1 secondary outcome
Day time sleepiness will be assessed using Epworth sleepiness score (ESS)
Time frame: 4 months after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed Saleh, MSc principal investigator
Otorhinolaryngology Specialist Assiut University Hospital
1 site in 1 country: see every site and its status.
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.