Effects of single and multiple oxygen administration under elevated ambient pressure on the healthy human kidney
- Conditions
- TINNITUS
- Registration Number
- DRKS00028147
- Lead Sponsor
- HBO-Zentrum Euregio Aachen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 20
HBO therapy in the context of a hearing loss/ tinnitus
- No known previous kidney diseases
- No known vascular diseases
- GFR > 90m/min (via CKD-EPI)
- No use of permanent medication with influence on renal function
- Sufficient knowledge of German
- GFR < 90ml/min
- Diseases with limitation of endocrine and exocrine renal function
- Known intolerance to high ambient pressures with inability to equalize pressure (via Valsalva maneuver). Exclusion is based on patient history and symptoms.
- Diseases of the middle ear
- claustrophobia
- Pulmonary disorders, such as severe bronchial asthma, emphysema, pneumothorax, acute infectious diseases
- Acute upper respiratory tract and/or sinus infections with sinunasal congestion (stuffy nose or rhinitis)
- Non-removable implants such as pacemakers, drug pumps, breast implants depending on manufacturer's instructions
- Pregnancy and lactation
- Severe cardiovascular diseases, in particular uncontrolled or poorly controlled arterial hypertension or heart failure
- Sickle cell anemia
- Condition following surgical procedures on the chest, ear or eye
- seizure disorders
- Taking medications that lower the seizure threshold (e.g., antidepressants)
- Persistent foramen ovale (PFO)
- Known vascular diseases
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoints will be measured using laboratory analysis of blood and urine samples. <br><br>The primary endpoints are:<br>1.Hyperbaric oxygen therapy causes adjustments in renal metabolism that can be detected by urinary parameters.<br>2.Repeated hyperbaric oxygen therapy induces responses in the body that resemble intermittent hypoxia.
- Secondary Outcome Measures
Name Time Method The following secondary hypotheses are put forward:<br>1. even single hyperbaric oxygen therapy has a detectable effect on metabolic adaptations of the kidney.<br>2. repeated hyperbaric oxygen therapy stimulates hematopoietic processes, primarily Erythropoetin formation.