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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05786378
Recruitment Status : Not yet recruiting
First Posted : March 27, 2023
Last Update Posted : April 19, 2023
Sponsor:
Information provided by (Responsible Party):
Mahmoud Hassan Ali, Assiut University

Study Description
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Brief Summary:
Assessment of the efficacy of Intratympanic platelet rich plasma injection for treatment of idiopathic suden sensorineural hearing loss

Condition or disease Intervention/treatment Phase
Hearing Loss, Sudden Hearing Loss, Sensorineural Hearing Loss Biological: Platelet Rich Plasma Drug: local anesthesia in external auditory canal Procedure: Intratympanic Injection Phase 2 Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of The Efficacy of Intratympanic Platelet Rich Plasma for Treatment of Sensorineural Hearing Loss.
Estimated Study Start Date : June 1, 2023
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: platlet rich plasma Biological: Platelet Rich Plasma

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.


Drug: local anesthesia in external auditory canal
local anesthesia cream (lidocaine cream) will be applied in external auditory canal for 15 minutes

Procedure: Intratympanic Injection
0.5-1 ml of PRP will be injected in middle ear cavity in round window niche Using microscope or endoscope.


Outcome Measures
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Primary Outcome Measures :
  1. Changes in Pure Tone Averages [ Time Frame: 6 weeks ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   5 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients have sudden idiopathic sensorineural hearing loss

Exclusion Criteria:

  1. patients has previous ear surgery.
  2. patients has absent cochlea in CT or MRI
  3. patients has Cancer,Chronic liver disease, Hemodynamic instability,Hypofibrinogenemia, Platelet dysfunction syndromes, Systemic disorder, sepsis, Low platelet count.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05786378


Contacts
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Contact: Mahmoud H Ali, MBBS 201062805374 ext 71621 mahmoud.nwawa@gmail.com

Locations
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Egypt
Otorhinolaryngeology Departement, Faculty of Medicine , Assuit Univerisity
Assiut, Assuit, Egypt, 71515
Sponsors and Collaborators
Assiut University
More Information
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Responsible Party: Mahmoud Hassan Ali, Resident doctor at Otolaryngology Departement, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT05786378    
Other Study ID Numbers: Intratympanic PRP
First Posted: March 27, 2023    Key Record Dates
Last Update Posted: April 19, 2023
Last Verified: April 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Loss, Sudden
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
 Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs