A common childhood epilepsy drug has the potential to change the lives of millions of people who suffer from sleep apnea, as a human trial has delivered surprising results in reducing symptoms and improving daytime alertness.
Sulthiame, known as Ospolot, is a medication most commonly prescribed to control the symptoms of childhood epilepsy. But in a double-blind, randomized controlled trial involving 298 people with obstructive sleep apnea (OSA), it had surprisingly good results in helping those who were unable to tolerate CPAP machines or other mouthpieces.
“The standard treatment for obstructive sleep apnea is sleeping with a machine that blows air through a face mask to keep the airways open," said Jan Hedner, a professor at Sahlgrenska University Hospital and the University of Gothenburg, Sweden. "Unfortunately, many people find these machines hard to use over the long term, so there is a need to find alternative treatments. We also a need better understanding of the underlying mechanisms in OSA to help clinicians give more personalized treatment.”
In the trial, patients being treated at 28 medical centers in Spain, France, Belgium, Germany and the Czech Republic were split into four groups, with 74 people taking 100 mg of sulthiame each day, 74 taking 200 mg, 75 taking 300 mg and 75 taking a placebo. All participants were assessed with polysomnography at the initial stage, then at four weeks and finally at 12 weeks. Polysomnography was used to measure breathing, oxygen levels in the blood, heart rhythm, eye movements, and brain and muscle activity during sleep.
The researchers found that those taking sulthiame had fewer breathing interruptions and higher oxygen levels in their blood. They also reported less lethargy during the day.
While a childhood epilepsy drug might seem like a strange match for OSA, sulthiame actually targets the respiratory system and stimulates the muscles in the upper airway.
Using the apnea-hypopnea index of AHI3a, which assesses breathing interruptions during sleep, the researchers found that patients on the highest dose of sulthiame had 39.9% lower frequency of respiratory pauses during the night. The cohort on the medium dose scored 34.8% lower, while the low-dose group scored 17.8% lower.
Then, using the apnea-hypopnea index (AHI) of AHI4, the scientists found that sulthiame reduced those respiratory interruptions by close to 50%, while significantly lowering oxygen levels in the blood.
However, there were some side effects, including pins and needles, headache, fatigue and nausea, though the researchers report that these were mild to moderate.
“People taking sulthiame in the trial had a reduction in OSA symptoms such as stopping breathing during the night and feeling sleepy during the day," said Hedner. "Their average levels of oxygen in the blood were also improved with the treatment. This suggests that sulthiame could be an effective treatment for OSA, especially for those who find they cannot use the existing mechanical treatments."
The results of the trial were presented at the European Respiratory Society (ERS) Congress in Vienna, Austria on September 10. Hedner says while the trial showed promising results, more studies will need to be conducted.
“Although sulthiame is already available as a treatment for childhood epilepsy, we still need to carry out a phase III study to confirm the beneficial respiratory effects of this drug in a larger group of patients with OSA," he added.
OSA isn't just a snoring issue; it can lead to serious health problems and comorbidities if not treated. And, right now, treatment is limited and most frequently invasive.
“Many of us know that we snore or that our partner snores," said Professor Sophia Schiza, head of the ERS assembly on sleep disordered breathing, but who was not involved in the research. "If snoring is accompanied by other symptoms, such as waking up often in the night, feeling fatigued and/or sleepy during the daytime, then it’s time to speak to a doctor. Because obstructive sleep apnoea increases the risk of serious health problems such as high blood pressure, heart and metabolic disease, it’s vital that we diagnose and treat the condition. Treatments are available, but because they don’t work for everyone, we need more ways to treat the disease, based on individualized diagnostic and treatment approaches.
“This is one of the first studies to suggest that a drug treatment could help some patients, and the results are promising," she added. "We need to continue testing sulthiame and other treatments to understand their long-term effects, including any side effects. For example, we’d like to see whether treatment can help with lowering blood pressure and preventing cardiovascular disease for people with OSA.”
