Obstructive sleep apnea (OSA) is a disorder where a person's breathing is interrupted during sleep. The current treatments for OSA have some limitations, such as not being effective, not being easy to use, or causing discomfort. Scientists are continuously looking for new ways to treat OSA.
A clinical trial was done to see if a medication called sulthiame (STM) could be used to treat OSA. STM works by inhibiting an enzyme called carbonic anhydrase, which helps regulate breathing. The researchers wanted to test if STM was safe and tolerable for people with moderate to severe OSA who were not able to use positive airway pressure treatment, which is one of the current treatments for OSA.
The trial was conducted over four weeks, and it was double-blind, randomized, and placebo-controlled. This means that neither the researchers nor the patients knew if they were receiving STM or a placebo. The patients were divided into three groups: one group received 400 mg of STM, another group received 200 mg of STM, and the last group received a placebo.
The trial found that STM reduced the number of apnea-hypopnea events that occurred during sleep. Apnea-hypopnea events are when breathing is interrupted during sleep. The researchers found that STM reduced the number of these events by more than 20 per hour, which is a strong reduction. Patients who received 400 mg of STM saw a 41% reduction in apnea-hypopnea events, while patients who received 200 mg saw a 32% reduction. Patients who received a placebo saw a reduction of only 5%. This means that STM was more effective at reducing apnea-hypopnea events than the placebo.
The researchers found that 79% of patients who received 400 mg of STM reported intermittent paresthesia, which is a tingling sensation in the body. 67% of patients who received 200 mg of STM reported the same, while only 18% of patients who received a placebo reported it. Additionally, 18% of patients who received 400 mg of STM reported dyspnea, which is shortness of breath. Six patients in the 400 mg group had to stop taking the medication because of side effects, but these were not serious.
The trial also found that overnight oxygen saturation improved by 1.1% after patients took 400 mg or 200 mg of STM. Oxygen saturation is the amount of oxygen in the blood, and a higher saturation level is better. The trial did not find any changes in patient-related outcomes, such as how well the patients felt or how well they slept.
Overall, the trial found that STM was safe for people with moderate to severe OSA who could not use positive airway pressure treatment. The medication was effective in reducing apnea-hypopnea events and improving oxygen saturation. However, the medication did have side effects, such as tingling sensations and shortness of breath. More research is needed to determine if STM is a viable treatment for OSA on a larger scale.
This trial is important because it provides new information about a potential treatment for OSA. If STM is found to be a safe and effective treatment, it could help many people with OSA who cannot use current treatments.