Assessment of The Efficacy of Intratympanic Platelet Rich Plasma for Treatment of Sensorineural Hearing Loss.
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|ClinicalTrials.gov Identifier: NCT05786378|
Recruitment Status : Not yet recruiting
First Posted : March 27, 2023
Last Update Posted : April 19, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Hearing Loss, Sudden Hearing Loss, Sensorineural Hearing Loss||Biological: Platelet Rich Plasma Drug: local anesthesia in external auditory canal Procedure: Intratympanic Injection||Phase 2 Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessment of The Efficacy of Intratympanic Platelet Rich Plasma for Treatment of Sensorineural Hearing Loss.|
|Estimated Study Start Date :||June 1, 2023|
|Estimated Primary Completion Date :||January 2024|
|Estimated Study Completion Date :||February 2024|
|Experimental: platlet rich plasma||
Biological: Platelet Rich Plasma
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.
Drug: local anesthesia in external auditory canal
local anesthesia cream (lidocaine cream) will be applied in external auditory canal for 15 minutes
Procedure: Intratympanic Injection
0.5-1 ml of PRP will be injected in middle ear cavity in round window niche Using microscope or endoscope.
- 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.
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|Ages Eligible for Study:||5 Years to 70 Years (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patients have sudden idiopathic sensorineural hearing loss
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05786378
|Contact: Mahmoud H Ali, MBBS||201062805374 ext email@example.com|
|Otorhinolaryngeology Departement, Faculty of Medicine , Assuit Univerisity|
|Assiut, Assuit, Egypt, 71515|
|Responsible Party:||Mahmoud Hassan Ali, Resident doctor at Otolaryngology Departement, Principal Investigator, Assiut University|
|Other Study ID Numbers:||
|First Posted:||March 27, 2023 Key Record Dates|
|Last Update Posted:||April 19, 2023|
|Last Verified:||April 2023|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Hearing Loss, Sensorineural
Hearing Loss, Sudden
Nervous System Diseases
Central Nervous System Depressants
Physiological Effects of Drugs