Clinical trial NCT06025097: 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
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Sensorineural Hearing Loss
Tinnitus
Keywords: Steroids
Platelet rich plasma
intratympanic steroids
Lead sponsor: CMH RWP Combined Military Hospital RWP: Rawalpindi
Sponsor class: OTHER_GOV
First posted: 2023-09-06
Enrollment: 70
Sex: ALL
Minimum age (years): 10
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group study, to show the therapeutic effects of Combination solution on diseases in fixed time.
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Improvement in Hearing
timeFrame: 2 weeks post treatment completion.
measure: Improvement in Tinnitus
timeFrame: 2 weeks post treatment completion.
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Combined Military Hospital
state: Punjab
Study officials:
affiliation: CMH Rawalpindi
name: Farhan Akbar, FCPS
role: STUDY_DIRECTOR
References: