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Intra-Tympanic Steroid With PRP Combination in Sensorineural Hearing Loss and Tinnitus.

Primary Purpose

Sensorineural Hearing Loss, Tinnitus

Status
Recruiting
Phase
Early Phase 1
Locations
Pakistan
Study Type
Interventional
Intervention
Combination Solution
Sponsored by
CMH RWP Combined Military Hospital RWP: Rawalpindi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sensorineural Hearing Loss focused on measuring Steroids, Platelet rich plasma, intratympanic steroids

Eligibility Criteria

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

Inclusion Criteria: Age: 10-70 yrs Capacity to have a Pure tone Audiometry test Disease SNHL; Unilateral or bilateral sensorineural hearing loss Without any identifiable cause Tinnitus; Subjective sensation of noise without any obvious source of sound Without any identifiable cause Hearing levels of 55dB or above Exclusion Criteria: Age: less than 10 or more than 70 yrs Conductive hearing loss/ Mixed Hearing loss Tumor, Neurologic cause of hearing loss/ tinnitus Past ear Surgery Any External, middle or inner Ear Disease other than SSNHL Traumatic Hearing Loss or Hearing Loss due to an obvious cause. Patients' refusal to follow-up Any contraindication to Steroids administration. Any Blood Disorder Non-consenting patients Comorbid: Diabetes Hypertension Cardio vascular diseases Obesity Etc.

Sites / Locations

  • Combined Military HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Treated Arm

Arm Description

Single arm study, Patients with SNHL and Tinnitus all were given same Composite solution consisting of (Methyl prednisone and Platelet rich plasma) via intr-atympanic route..

Outcomes

Primary Outcome Measures

Improvement in Hearing
Improvement in hearing as per Audiogram, measured in decibels.
Improvement in Tinnitus
Improvement in Tinnitus as per Visual analogue scale from 1 to 10 with 1 being the lowest improvement and 10 being the best.

Secondary Outcome Measures

Full Information

First Posted
August 10, 2023
Last Updated
September 17, 2023
Sponsor
CMH RWP Combined Military Hospital RWP: Rawalpindi
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1. Study Identification

Unique Protocol Identification Number
NCT06025097
Brief Title
Intra-Tympanic Steroid With PRP Combination in Sensorineural Hearing Loss and Tinnitus.
Official Title
Therapeutic Effect of Intra-Tympanic Methyl Prednisone-platelet Rich Plasma Combination in Sensorineural Hearing Loss and Tinnitus of Cochlear Origin.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
October 21, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CMH RWP Combined Military Hospital RWP: Rawalpindi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Steroids are used widely for the treatment of Sensorineural hearing loss worldwide. The difficulty lies with efficient delivery of the drug into the cochlea, which is already a sealed chamber with limited blood supply that too with an end Artery. We intend to extrapolate its effects by combining it with Platelet rich plasma. intra-tympanic delivery is achieved with injection via tympanic membrane and its absorption via round window is hastened by posture maintenance for about half an hour. PRP is an autologous biologic fluid which has excellent safety profile and is already in use by various specialties.
Detailed Description
Definitions: Sensorineural Hearing Loss: Hearing loss occurring due to pathologies of cochlea. Platelet-rich plasma : Platelet-rich plasma is an autologous biological product separated from blood after removal of Red blood cells. It is the plasma portion of blood which is simply rich of platelets. Preparations: Intratympanic methyl prednisone + Autologous PRP: 2ml Solution (1ml of methyl prednisone 40mg/ml + 1ml of PRP) Materials and Methods: Inclusion Criteria: mentioned in pertinent section Exclusion Criteria: mentioned in pertinent section Methodology: This will be an Interventional study, prior permission from Hospitals Ethical Review Board will be taken. Informed consent will be obtained from the patients with regards to participation the study. All the patients in which the presentation to Ear Nose Throat (ENT) clinic is SNHL or Subjective tinnitus and also satisfying the inclusion criteria will be selected. SNHL will be graded according to the audiogram and values will be recorded to the nearest +5db with round off. The Tinnitus will be graded on visual analogue scale graded from 1 to 10 (1= No tinnitus while 10 being the worst). After recording the pre-treatment data these patients will be scheduled for intervention. Patients will receive the solution consisting of 1ml methyl prednisone (40mg/ml) and 1ml of PRP via intra-tympanic route. The solution will be injected into the tympanic cavity via the tympanic membrane injection (intra-tympanic route). Patients will receive repeated doses of same intra-tympanic injections on every third day for a total of 3 consecutive doses (in 9 days). Hearing assessment via Audiometry will be done post-treatment after 2 weeks of finishing the treatment (23rd day after starting the therapy). Procedure: On receiving a patient at ENT department with a diagnosis of SNHL/ tinnitus, patient will be scheduled for intra-tympanic injection session. All of the intra-tympanic injections will be performed by the same ENT Doctor. Patient will be positioned in sitting posture, head tilted sideways and rotated slightly to instill the pyodine solution into the ear for 5 minutes. Then after cleaning with a sterile suction tip, xylocaine 10% solution will be sprayed into the ear canal and a wick soaked in xylocaine left there for 5 more minutes. The wick will then be removed and ear will be examined to exclude any physical disease or deformity in the external ear. Head will be brought to the examining position and a sterile 3cc syringe will be loaded with 1 ml of 40mg/ml methyl prednisone and 1 ml of PRP. 3cc syringe needle is replaced with 25 Guage Lumber Puncture needle. Under guidance of a Microscope or 0-degree rigid Endoscope, one point Pin-hole will be made by just piercing the Tympanic membrane antero-inferiorly and the prepared solution will be instilled. While instilling the solution a meniscus would be seen rising from inferior to superior aspect of the tympanic membrane. The patient will be made to lie in supine position and then will be made to stay in same position for about 15-30 mins (so as to hasten the absorption through round window and to prevent escape of solution via Eustachian tube). This supine position would also facilitate establishment of a reservoir in the mastoid antrum to slowly discharge over time and further the absorption through round window. A cotton wick will be left in the ear canal to be removed after an hour. The procedure will be repeated at every 3rd day till a total of three procedures. Patient will be further called for follow up Audiometry, at 2 weeks after finishing the treatment. Any improvement from the pre-treatment audiometry will be noted. Improvement will be labelled as Mild; of 10 decibels, partial; 11-25 decibels and Good; above 25 decibels. The improvements in tinnitus will be ascertained subjectively with a visual analogue scale graded from 1 to 10. Data will be recorded and analyzed and results will be published in due course of time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sensorineural Hearing Loss, Tinnitus
Keywords
Steroids, Platelet rich plasma, intratympanic steroids

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Single group study, to show the therapeutic effects of Combination solution on diseases in fixed time.
Masking
None (Open Label)
Masking Description
Care giver and patient both are known to the treatment being offered under investigation.
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Treated Arm
Arm Type
Experimental
Arm Description
Single arm study, Patients with SNHL and Tinnitus all were given same Composite solution consisting of (Methyl prednisone and Platelet rich plasma) via intr-atympanic route..
Intervention Type
Drug
Intervention Name(s)
Combination Solution
Other Intervention Name(s)
PRP + Solumedrol
Intervention Description
Methyl Prednisone (Trade name: SOLU-MEDROL) + Platelet rich Plasma (Autologous Biological product) via intra-tympanic rout about 1-1.5 ml.
Primary Outcome Measure Information:
Title
Improvement in Hearing
Description
Improvement in hearing as per Audiogram, measured in decibels.
Time Frame
2 weeks post treatment completion.
Title
Improvement in Tinnitus
Description
Improvement in Tinnitus as per Visual analogue scale from 1 to 10 with 1 being the lowest improvement and 10 being the best.
Time Frame
2 weeks post treatment completion.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 10-70 yrs Capacity to have a Pure tone Audiometry test Disease SNHL; Unilateral or bilateral sensorineural hearing loss Without any identifiable cause Tinnitus; Subjective sensation of noise without any obvious source of sound Without any identifiable cause Hearing levels of 55dB or above Exclusion Criteria: Age: less than 10 or more than 70 yrs Conductive hearing loss/ Mixed Hearing loss Tumor, Neurologic cause of hearing loss/ tinnitus Past ear Surgery Any External, middle or inner Ear Disease other than SSNHL Traumatic Hearing Loss or Hearing Loss due to an obvious cause. Patients' refusal to follow-up Any contraindication to Steroids administration. Any Blood Disorder Non-consenting patients Comorbid: Diabetes Hypertension Cardio vascular diseases Obesity Etc.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad Noman Karim, MBBS
Phone
03090062305
Email
f9noman@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad Noman, FCPS
Phone
03313358884
Email
f7nomi@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Farhan Akbar, FCPS
Organizational Affiliation
CMH Rawalpindi
Official's Role
Study Director
Facility Information:
Facility Name
Combined Military Hospital
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
75700
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammad Noman Karim, FCPS
Email
f9noman@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
If there is a need to analyze the data for a particular clinical question, than only the data would be shared with other researchers.

Learn more about this trial

Intra-Tympanic Steroid With PRP Combination in Sensorineural Hearing Loss and Tinnitus.

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