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Study of Hyperbaric Oxygen Therapy Combined with Standard Treatment for Patients with Sudden Hearing Loss

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on idiopathic sudden sensorineural hearing loss, a condition where hearing suddenly deteriorates without a known cause. The study aims to determine if adding hyperbaric oxygen treatment to standard care can improve hearing outcomes better than standard care alone. Hyperbaric oxygen involves breathing pure oxygen in a pressurized chamber.

During the study, participants will receive either standard care treatment alone or standard care combined with hyperbaric oxygen therapy. The treatment involves breathing a mixture of nitrous oxide and oxygen through inhalation. The maximum treatment period is 16 days, with each session lasting up to 95 minutes. The total treatment time may reach up to 1520 minutes across all sessions.

Hearing ability will be measured using various tests throughout the study period, with a particular focus on hearing levels after three months of treatment. The study will track changes in hearing ability, word recognition, and how the treatment affects participants' daily communication abilities and overall quality of life.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Your hearing will be tested using pure tone audiometry to measure hearing thresholds at different frequencies
You will complete two questionnaires: the APHAB (which assesses communication problems) and RAND-12 (which evaluates general health status)
Step 2
Treatment assignment
You will be randomly assigned to receive either standard care alone or standard care plus hyperbaric oxygen therapy (HBOT)
If assigned to the HBOT group, treatment must begin within 7 days of your hearing loss onset
Step 3
Treatment period
You will receive treatment with oxygen through inhalation
The treatment will be administered in a specialized chamber if you are in the HBOT group
Your condition will be monitored for any side effects or adverse events during the treatment period
Step 4
Follow-up assessment (Week 14)
Your hearing will be tested again using pure tone audiometry
The test will measure hearing thresholds at four frequencies: 0.5 kHz, 1 kHz, 2 kHz, and 4 kHz
You will complete a word recognition test to evaluate your ability to understand speech
You will fill out the same questionnaires (APHAB and RAND-12) to assess changes in your communication abilities and general health
Your hearing recovery will be evaluated using specific medical criteria (Siegel's criteria and AAO-HNS criteria)

Who can join the trial?

6 criteria

Age between 18 and 80 years old
Sudden hearing loss that started no more than 7 days ago
Able to start hyperbaric oxygen therapy (HBOT) within 7 days from when hearing loss began
Hearing test (pure tone audiometry) showing nerve-related hearing loss with at least 30 decibels (dB) loss in three frequencies in a row
Doctor's assessment confirms that the hearing loss has no known cause (idiopathic)
Average hearing threshold of 50 decibels or more when tested at different sound frequencies (0.5, 1, 2, and 4 kilohertz)

Who cannot join the trial?

13 criteria

Patients younger than 18 years old cannot participate in the study
Patients who have contraindications to hyperbaric oxygen therapy (medical reasons that make this treatment unsafe)
Patients with hearing loss due to known causes (since this study is for idiopathic/unknown cause hearing loss only)
Patients who have had hearing loss symptoms for more than 14 days
Patients with chronic ear diseases (long-term ear conditions)
Patients who cannot equalize ear pressure (inability to "pop" their ears)
Patients with claustrophobia (fear of enclosed spaces)
Patients with untreated pneumothorax (collapsed lung)
Patients with severe heart or lung diseases
Pregnant women
Patients who have previously received hyperbaric oxygen therapy for hearing loss
Patients who cannot provide informed consent
Patients who are participating in other clinical trials

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Verified sites

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Verified
Akershus University Hospital
Lorenskog, Norway
Verified
Helse Bergen HF
Bergen, Norway
Responsive
Sykehuset Oestfold HF Kalnes
Graalum, Norway

Trial locations

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Investigated drugs

Hyperbaric Oxygen Therapy (HBOT) is a treatment where a patient breathes pure oxygen in a pressurized chamber. During this therapy, the patient is exposed to oxygen at higher pressure than normal atmospheric pressure. This allows more oxygen to dissolve in the blood and reach damaged tissues, potentially helping to improve hearing loss. Standard Care Treatment for sudden hearing loss typically includes oral steroids and other conventional medical treatments that doctors normally use to treat sudden hearing loss. This is the basic treatment that all patients receive according to current medical guidelines. The combination of these treatments is being studied to determine if adding hyperbaric oxygen therapy to standard care can lead to better hearing outcomes in patients with sudden, unexplained hearing loss.

What is already known about the treatment

Hyperbaric Oxygen Therapy (HBOT) - A medical treatment where pure oxygen is administered to a patient in a pressurized chamber, allowing the body to take in higher levels of oxygen than would be possible at normal atmospheric pressure. This therapy is used as an adjunctive treatment for sudden hearing loss (ISSNHL), where it helps increase oxygen delivery to the damaged inner ear tissues. The treatment involves patients breathing 100% oxygen while inside a specialized chamber for typically 60-90 minute sessions, with the pressure equivalent to being 30-60 feet underwater. HBOT works by increasing the amount of dissolved oxygen in the blood plasma, which can help reduce inflammation and promote healing in oxygen-deprived tissues of the inner ear.

Investigated diseases

Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL) - A condition characterized by rapid and unexplained hearing loss that develops over a period of up to 72 hours. It typically affects one ear and occurs when there is damage to the inner ear or the nerve pathways between the inner ear and the brain. The hearing loss is considered "sensorineural" because it stems from problems in the inner ear or auditory nerve, rather than the outer or middle ear. The condition can be accompanied by tinnitus (ringing in the ears), dizziness, or a feeling of ear fullness. The exact cause remains unknown, which is why it's termed "idiopathic."