Assessment of The Efficacy of Intratympanic Platelet Rich Plasma for Treatment of Sensorineural Hearing Loss.

Hearing Loss Clinical Trial

Official title:

Assessment of The Efficacy of Intratympanic Platelet Rich Plasma for Treatment of Sensorineural Hearing Loss.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05786378
• Other study ID #: Intratympanic PRP
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: June 1, 2023
• Est. completion date: February 2024

Study information

• Verified date: April 2023
• Source: Assiut University
• Contact: Mahmoud H Ali, MBBS
• Phone: 201062805374
• Email: mahmoud.nwawa[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Assessment of the efficacy of Intratympanic platelet rich plasma injection for treatment of idiopathic suden sensorineural hearing loss

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 23
• Est. completion date: February 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients have sudden idiopathic sensorineural hearing loss

Exclusion Criteria:

1. patients has previous ear surgery.

2. patients has absent cochlea in CT or MRI

3. patients has Cancer,Chronic liver disease, Hemodynamic instability,Hypofibrinogenemia, Platelet dysfunction syndromes, Systemic disorder, sepsis, Low platelet count.

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural
• Hearing Loss, Sudden

Intervention

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.

Locations

Country	Name	City	State
Egypt	Otorhinolaryngeology Departement, Faculty of Medicine , Assuit Univerisity	Assiut	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks