Obstructive Sleep ApneaNCT04928404
Barbed Suspension of the Tongue Base for Treatment of Obstructive Sleep Apnea Patients
A study testing tongue base suspension using barbed suture in people with Obstructive Sleep Apnea, run by Sohag University at 1 site in Egypt.
Trial summary
Obstructive sleep apnea syndrome (OSAS) is a common clinical condition in which the throat narrows or collapses repeatedly during sleep, causing obstructive sleep apnea events. One of the most common sites for collapse during sleep is hypo-pharyngeal space. 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?
- tongue base suspension using barbed suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jun 2021to 30 Dec 2022
- 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
- BMI of patients less than 35 kg/m2.
- Patients who have symptoms and signs of OSA.
- Moderate to severe OSAHS confirmed by formal polysomnography (defined as an AHI ≥15).
- Friedman tongue position III or IV.
- Documented failure/refusal of attempts of conservative treatment measures (not limited to continuous positive airway pressure).
- The presence of retrolingual collapse confirmed preoperatively with flexible fiberoptic endoscope during Muller maneuver.
- Patients have macroglossia as defined by posterior airspace (PAS) of ≤10mm.
Who cannot join
- Failure to attend postoperative follow-up polysomnography within 6 months of surgery.
- Previous surgery to the base of the tongue or other surgical treatment of OSAHS.
- A history of malignancy or infection of the head and neck region, laryngeal trauma, or other previous oropharyngeal/laryngeal surgery.
- Patients have retrognanthia sella-nasion-supra mentale (SNB) ≥76º.
- Huge lymphoid tissue of the tongue and/or lingual tonsil.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sohag university
Sohag, 82524
hassan noamen, professor, portal@med.sohag.edu.eg
About this study
Obstructive sleep apnea syndrome (OSAS) is a common clinical condition in which the throat narrows or collapses repeatedly during sleep, causing obstructive sleep apnea events.
One of the most common sites for collapse during sleep is hypo-pharyngeal space. It was founded in 50% of OSA patients those have moderate and severe apnea.
DeRowe et al invented the Tongue base suspension operation in 1998 for sleep disordered breathing.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- tongue base suspension using barbed suture
- Keywords
- tongue base, tongue base suspension, barbed suture
- 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.
tongue base suspension using barbed sutureProcedure or surgery
all patients will undergo multi-level surgeries .Therefor, Anterolateral advancement pharyngeoplasty (ALA) or Barbed Reposition Pharyngoplasty (BRP) will be applied to improve retro-palatal obstruction and tongue base suspension using barbed suture for retro-lingual obstruction.
| Study group | Role | What they receive |
|---|---|---|
| obstructive sleep apnea patients | Other | Not described Receives: Procedure: tongue base suspension using barbed suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in obstructive sleep apnea
using polysomnography
Measured: 3 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 posted16 Jun 2021
- Study start12 Jun 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Dec 2022 (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 Sohag 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Abd Elmateen Moussa, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04928404
- Sponsor's protocol ID
- Soh-med-21-06-12
- Status last verified
- Jun 2021
- First submitted
- 15 Jun 2021
- Last updated
- 22 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barbed Suspension of the Tongue Base for Treatment of Obstructive Sleep Apnea Patients
- ClinicalTrials.gov ID
- NCT04928404
- Acronym / sponsor ID
- Soh-med-21-06-12
- Conditions
- Obstructive Sleep Apnea
- Keywords
- tongue base, tongue base suspension, barbed suture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 12 Jun 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 16 Jun 2021 (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.
Obstructive sleep apnea syndrome (OSAS) is a common clinical condition in which the throat narrows or collapses repeatedly during sleep, causing obstructive sleep apnea events.
One of the most common sites for collapse during sleep is hypo-pharyngeal space. It was founded in 50% of OSA patients those have moderate and severe apnea.
DeRowe et al invented the Tongue base suspension operation in 1998 for sleep disordered breathing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| obstructive sleep apnea patients | Other | Procedure: tongue base suspension using barbed suture |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- BMI of patients less than 35 kg/m2.
- Patients who have symptoms and signs of OSA.
- Moderate to severe OSAHS confirmed by formal polysomnography (defined as an AHI ≥15).
- Friedman tongue position III or IV.
- Documented failure/refusal of attempts of conservative treatment measures (not limited to continuous positive airway pressure).
Key exclusion criteria (5 listed)
- Failure to attend postoperative follow-up polysomnography within 6 months of surgery.
- Previous surgery to the base of the tongue or other surgical treatment of OSAHS.
- A history of malignancy or infection of the head and neck region, laryngeal trauma, or other previous oropharyngeal/laryngeal surgery.
- Patients have retrognanthia sella-nasion-supra mentale (SNB) ≥76º.
- Huge lymphoid tissue of the tongue and/or lingual tonsil.
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 |
|---|---|---|
| tongue base suspension using barbed sutureall patients will undergo multi-level surgeries .Therefor, Anterolateral advancement pharyngeoplasty (ALA) or Barbed Reposition Pharyngoplasty (BRP) will be applied to improve retro-palatal obstruction and tongue base suspension using barbed suture for retro-lingual obstruction. | Procedure or surgery | obstructive sleep apnea patients |
Primary outcome
changes in obstructive sleep apnea
Time frame: 3 months after intervention
using polysomnography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
- Individual participant dataSharing planned: Yes
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tongue base suspension using barbed suture in people with Obstructive Sleep Apnea, run by Sohag 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 7 inclusion and 5 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 22 Jun 2021. 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 Mohameed Moussa, specialist (01011178222, mabdelmatien_post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in obstructive sleep apnea (time frame: 3 months after intervention). 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 22 Jun 2021.