search
Back to results

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

Primary Purpose

Hearing Loss, Sudden, Hearing Loss, Sensorineural, Hearing Loss

Status
Not yet recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Platelet Rich Plasma
local anesthesia in external auditory canal
Intratympanic Injection
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss, Sudden

Eligibility Criteria

5 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients have sudden idiopathic sensorineural hearing loss Exclusion Criteria: 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.

Sites / Locations

  • Otorhinolaryngeology Departement, Faculty of Medicine , Assuit Univerisity

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

platlet rich plasma

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 7, 2023
Last Updated
April 18, 2023
Sponsor
Assiut University
search

1. Study Identification

Unique Protocol Identification Number
NCT05786378
Brief Title
Assessment of The Efficacy of Intratympanic Platelet Rich Plasma for Treatment of Sensorineural Hearing Loss.
Official Title
Assessment of The Efficacy of Intratympanic Platelet Rich Plasma for Treatment of Sensorineural Hearing Loss.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Sudden, Hearing Loss, Sensorineural, Hearing Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
platlet rich plasma
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Platelet Rich Plasma
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
local anesthesia in external auditory canal
Intervention Description
local anesthesia cream (lidocaine cream) will be applied in external auditory canal for 15 minutes
Intervention Type
Procedure
Intervention Name(s)
Intratympanic Injection
Intervention Description
0.5-1 ml of PRP will be injected in middle ear cavity in round window niche Using microscope or endoscope.
Primary Outcome Measure Information:
Title
Changes in Pure Tone Averages
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients have sudden idiopathic sensorineural hearing loss Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud H Ali, MBBS
Phone
201062805374
Ext
71621
Email
mahmoud.nwawa@gmail.com
Facility Information:
Facility Name
Otorhinolaryngeology Departement, Faculty of Medicine , Assuit Univerisity
City
Assiut
State/Province
Assuit
ZIP/Postal Code
71515
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs