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

• ClinicalTrials.gov Identifier: NCT06025097
• Recruitment Status: Recruiting
• First Posted: September 6, 2023
• Last Update Posted: September 21, 2023
• Sponsor: CMH RWP Combined Military Hospital RWP: Rawalpindi
• Information provided by (Responsible Party): Muhammad Noman Karim, CMH RWP Combined Military Hospital RWP: Rawalpindi

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.

Condition or disease	Intervention/treatment	Phase
Sensorineural Hearing Loss; Tinnitus	Drug: Combination Solution	Early Phase 1

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 70 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention 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.
• Primary Purpose: Treatment
• Official Title: Therapeutic Effect of Intra-Tympanic Methyl Prednisone-platelet Rich Plasma Combination in Sensorineural Hearing Loss and Tinnitus of Cochlear Origin.
• Actual Study Start Date: September 1, 2023
• Estimated Primary Completion Date: September 30, 2023
• Estimated Study Completion Date: October 21, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Single Treated Arm; 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..	Drug: Combination Solution; Methyl Prednisone (Trade name: SOLU-MEDROL) + Platelet rich Plasma (Autologous Biological product) via intra-tympanic rout about 1-1.5 ml.; Other Name: PRP + Solumedrol

Outcome Measures

Primary Outcome Measures :

1. Improvement in Hearing [ Time Frame: 2 weeks post treatment completion. ]
   Improvement in hearing as per Audiogram, measured in decibels.
2. Improvement in Tinnitus [ Time Frame: 2 weeks post treatment completion. ]
   Improvement in Tinnitus as per Visual analogue scale from 1 to 10 with 1 being the lowest improvement and 10 being the best.

Eligibility Criteria

• Ages Eligible for Study: 10 Years to 70 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Age: 10-70 yrs
• Capacity to have a Pure tone Audiometry test

• Disease

  1. SNHL;

     • Unilateral or bilateral sensorineural hearing loss
     • Without any identifiable cause

  2. 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.

Contacts and Locations

Contacts

Contact: Muhammad Noman Karim, MBBS; 03090062305; f9noman@gmail.com

Contact: Muhammad Noman, FCPS; 03313358884; f7nomi@gmail.com

Locations

Pakistan

Combined Military Hospital; Recruiting

Rawalpindi, Punjab, Pakistan, 75700

Contact: Muhammad Noman Karim, FCPS f9noman@gmail.com

Sponsors and Collaborators

CMH RWP Combined Military Hospital RWP: Rawalpindi

Investigators

• Study Director: Farhan Akbar, FCPS; CMH Rawalpindi

More Information

• Responsible Party: Muhammad Noman Karim, Principal Investigator, Otolaryngology Dept, CMH Rawalpindi, CMH RWP Combined Military Hospital RWP: Rawalpindi
• ClinicalTrials.gov Identifier: NCT06025097
• Other Study ID Numbers: 001
• First Posted: September 6, 2023
• Last Update Posted: September 21, 2023
• Last Verified: September 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• 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.

• 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

Keywords provided by Muhammad Noman Karim, CMH RWP Combined Military Hospital RWP: Rawalpindi:

Steroids; Platelet rich plasma; intratympanic steroids

Additional relevant MeSH terms:

Hearing Loss; Deafness; Tinnitus; Hearing Loss, Sensorineural; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Methylprednisolone Hemisuccinate; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Neuroprotective Agents; Protective Agents; Antineoplastic Agents, Hormonal; Antineoplastic Agents