Hearing Loss, SuddenPhase 2/3NCT05786378
Assessment of The Efficacy of Intratympanic Platelet Rich Plasma for Treatment of Sensorineural Hearing Loss.
A Phase 2/3 study testing Platelet Rich Plasma, local anesthesia in external auditory canal and Intratympanic Injection in people with Hearing Loss, Sudden and Hearing Loss, Sensorineural, run by Assiut University at 1 site in Egypt.
Trial summary
Assessment of the efficacy of Intratympanic platelet rich plasma injection for treatment of idiopathic suden sensorineural hearing loss Read more about this study
- Who is it for?
- Ages 5 to 70 years
- Conditions the study is for
- Hearing Loss, Sudden, Hearing Loss, Sensorineural, Hearing Loss
- What is being tested?
- Platelet Rich Plasma, local anesthesia in external auditory canal and Intratympanic Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to Feb 2024
- Phase
- Phase 2/3
- 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 5 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients have sudden idiopathic sensorineural hearing loss
Who cannot join
- patients has previous ear surgery.
- patients has absent cochlea in CT or MRI
- patients has Cancer,Chronic liver disease, Hemodynamic instability,Hypofibrinogenemia, Platelet dysfunction syndromes, Systemic disorder, sepsis, Low platelet count.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Otorhinolaryngeology Departement, Faculty of Medicine , Assuit Univerisity
Asyut, Assuit, 71515
About this study
Assessment of the efficacy of Intratympanic platelet rich plasma injection for treatment of idiopathic suden sensorineural hearing loss
Read the detailed description
Sensorineural hearing loss is the collective term for hearing damage to the cochlea and auditory nerve and is by far the most common type of hearing loss in adults, accounting for over 90% of all cases. Sensorineural hearing loss is a heterogeneous disorder, which can arise due to damage to pathway for sound impulses from the hair cells of inner ear to auditory nerve and less commonly brain.
Sensorineural hearing loss is a challenge to physicians, as it progresses with age and causes significant reductions in quality of life and there are no treatments to reverse its effects, other than sound amplification with the use of hearing aids or direct auditory nerve stimulation via cochlear implantation.
Platelet-rich Plasma (PRP) Therapy is a cutting-edge procedure that is revolutionizing the hearing loss and deafness. Intratympanic instillation of Platelet-rich Plasma (PRP) does wonder to the hair cells of inner ear, thus improving the hearing.
- Being tested
- Platelet Rich Plasma, local anesthesia in external auditory canal, Intratympanic Injection
- Medical subject headings
- Hearing Loss, Sudden, Hearing Loss, Sensorineural, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet Rich PlasmaBiological
Sample of patient's blood drawn at time of Treatment; the blood drawing occurs with addition of anticoagulant such as citrate dextrose A to prevent platelet activation prior to its use.
Obtain whole blood by venipuncture in acid citrate dextrose (ACD) tubes. Centrifuge the blood using a 'soft' spin. Transfer the supernatant plasma containing platelets into another sterile tube (without anticoagulant).
Centrifuge tube at a higher speed (a hard spin) to obtain a platelet concentrate.
The lower 1/3rd is PRP and upper 2/3rd is platelet-poor plasma (PPP). At the bottom of the tube, platelet pellets are formed.
PRP activation prior to injection. PRP can be activated exogenously by calcium chloride.
local anesthesia in external auditory canalDrug
local anesthesia cream (lidocaine cream) will be applied in external auditory canal for 15 minutes
Intratympanic InjectionProcedure or surgery
0.5-1 ml of PRP will be injected in middle ear cavity in round window niche Using microscope or endoscope.
| Study group | Role | What they receive |
|---|---|---|
| platlet rich plasma | Experimental | Not described Receives: Biological: Platelet Rich Plasma; Drug: local anesthesia in external auditory canal; Procedure: Intratympanic Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Pure Tone Averages
Continuous pure tone averages calculated from pure tone audiometry will be summarized using the mean, standard deviation, median, 25th percentile, 75th percentile, minimum and maximum.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start1 Jun 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, SuddenStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Hassan Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786378
- Sponsor's protocol ID
- Intratympanic PRP
- Status last verified
- Apr 2023
- First submitted
- 7 Mar 2023
- Last updated
- 19 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of The Efficacy of Intratympanic Platelet Rich Plasma for Treatment of Sensorineural Hearing Loss.
- ClinicalTrials.gov ID
- NCT05786378
- Acronym / sponsor ID
- Intratympanic PRP
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 27 Mar 2023 (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.
Assessment of the efficacy of Intratympanic platelet rich plasma injection for treatment of idiopathic suden sensorineural hearing loss
Detailed description
Sensorineural hearing loss is the collective term for hearing damage to the cochlea and auditory nerve and is by far the most common type of hearing loss in adults, accounting for over 90% of all cases. Sensorineural hearing loss is a heterogeneous disorder, which can arise due to damage to pathway for sound impulses from the hair cells of inner ear to auditory nerve and less commonly brain.
Sensorineural hearing loss is a challenge to physicians, as it progresses with age and causes significant reductions in quality of life and there are no treatments to reverse its effects, other than sound amplification with the use of hearing aids or direct auditory nerve stimulation via cochlear implantation.
Platelet-rich Plasma (PRP) Therapy is a cutting-edge procedure that is revolutionizing the hearing loss and deafness. Intratympanic instillation of Platelet-rich Plasma (PRP) does wonder to the hair cells of inner ear, thus improving the hearing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| platlet rich plasma | Experimental | Biological: Platelet Rich Plasma, Drug: local anesthesia in external auditory canal, Procedure: Intratympanic Injection |
Who may qualify
- Ages
- 5 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients have sudden idiopathic sensorineural hearing loss
Key exclusion criteria (3 listed)
- patients has previous ear surgery.
- patients has absent cochlea in CT or MRI
- patients has Cancer,Chronic liver disease, Hemodynamic instability,Hypofibrinogenemia, Platelet dysfunction syndromes, Systemic disorder, sepsis, Low platelet count.
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 |
|---|---|---|
| Platelet Rich PlasmaSample of patient's blood drawn at time of Treatment; the blood drawing occurs with addition of anticoagulant such as citrate dextrose A to prevent platelet activation prior to its use. Obtain whole blood by venipuncture in acid citrate dextrose (ACD) tubes. Centrifuge the blood using a 'soft' spin. Transfer the supernatant plasma containing platelets into another sterile tube (without anticoagulant). Centrifuge tube at a higher speed (a hard spin) to obtain a platelet concentrate. The lower 1/3rd is PRP and upper 2/3rd is platelet-poor plasma (PPP). At the bottom of the tube, platelet pellets are formed. PRP activation prior to injection. PRP can be activated exogenously by calcium chloride. | Biological | platlet rich plasma |
| local anesthesia in external auditory canallocal anesthesia cream (lidocaine cream) will be applied in external auditory canal for 15 minutes | Drug | platlet rich plasma |
| Intratympanic Injection0.5-1 ml of PRP will be injected in middle ear cavity in round window niche Using microscope or endoscope. | Procedure or surgery | platlet rich plasma |
Primary outcome
Changes in Pure Tone Averages
Time frame: 6 weeks
Continuous pure tone averages calculated from pure tone audiometry will be summarized using the mean, standard deviation, median, 25th percentile, 75th percentile, minimum and maximum.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
Related trials for Hearing Loss, Sudden
RecruitingPhase 2
Efficacy and Safety of Hydroxychloroquine in the Treatment of Sudden Sensorineural Hearing Loss
Sudden Hearing Loss
Not yet recruitingPhase 3
Autologous Circulating Extracellular Vesicles for Total-Type Sudden Sensorineural Hearing Loss
Sudden Sensorineural Hearing Loss (SSNHL)
Not yet recruitingPhase 2
Efficacy and Safety of Intracochlear Injection of Glucocorticoid Through the Round Window Membrane in Patients With Profound or Complete Sudden Sensorineural Hearing Loss
Sudden Hearing Loss
RecruitingPhase 4
Comparison of the Effectiveness of Oral and Intratympanic Corticosteroid Treatments in Patients Diagnosed With Sudden Sensorineural Hearing Loss
Sudden Sensorineural Hearing Loss
Not yet recruiting
CGM-guided Patch Pump vs Basal-Bolus Injection for Steroid-Induced Hyperglycemia in Sudden Sensorineural Hearing Loss: SHIP Trial
Sudden Sensorineural Hearing Loss (SSNHL), Prediabetes / Type 2 Diabetes
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 Phase 2/3 study testing Platelet Rich Plasma, local anesthesia in external auditory canal and Intratympanic Injection in people with Hearing Loss, Sudden and Hearing Loss, Sensorineural, 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 1 inclusion and 3 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 19 Apr 2023. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Mahmoud H Ali, MBBS (201062805374 ext. 71621, mahmoud.nwawa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Pure Tone Averages (time frame: 6 weeks). 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 19 Apr 2023.