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

NCT06025097 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Sensorineural Hearing Loss; Tinnitus

Keywords

Steroids; Platelet rich plasma; intratympanic steroids

Outcome Measures

Primary Outcomes (2)

• Improvement in Hearing

  Improvement in hearing as per Audiogram, measured in decibels.

  2 weeks post treatment completion.

• 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.

  2 weeks post treatment completion.

Study Arms (1)

Single Treated Arm

EXPERIMENTAL

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

Interventions

Combination Solution DRUG

Methyl Prednisone (Trade name: SOLU-MEDROL) + Platelet rich Plasma (Autologous Biological product) via intra-tympanic rout about 1-1.5 ml.

Also known as: PRP + Solumedrol

Single Treated Arm

Eligibility Criteria

• Age: 10 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CMH RWP Combined Military Hospital RWP: Rawalpindi: lead

Study Sites (1)

Combined Military Hospital

Rawalpindi, Punjab Province, 75700, Pakistan

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural; Tinnitus

Interventions

TEC solution; Methylprednisolone Hemisuccinate

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Farhan Akbar, FCPS

  CMH Rawalpindi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Care giver and patient both are known to the treatment being offered under investigation.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Otolaryngology Dept, CMH Rawalpindi

Model Details: Single group study, to show the therapeutic effects of Combination solution on diseases in fixed time.

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: September 6, 2023
• Study Start: September 1, 2023
• Primary Completion: September 30, 2023
• Study Completion: October 21, 2023
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)