Ongoing Clinical Trials for Obstructive Sleep Apnoea Syndrome
Currently, there are 4 ongoing clinical trials investigating new treatments for obstructive sleep apnoea syndrome. These studies are taking place across several European countries and are exploring different approaches, including inhaled medications, combination therapies, hormonal treatments, and metabolic interventions. Participants in these trials may have the opportunity to access experimental treatments that could help manage breathing interruptions during sleep.
Clinical trial locations
- Belgium
- Czechia
- Denmark
- France
- Germany
- Sweden
Study of Nacystelyn for Patients with Obstructive Sleep Apnea
This trial is examining whether Nacystelyn, delivered through a dry-powder inhaler, can help improve breathing during sleep. The medication works by breaking down mucus and reducing inflammation in the airways, which may help keep them open during sleep.
Main inclusion criteria: Adults with an Apnea-Hypopnoea Index between 15 and 30 per hour can participate. You should not have used CPAP therapy or have stopped using it for at least two months before joining. Your oxygen desaturation index must be 10 or more, and your BMI should be between 18 and 35 kg/m². Women of childbearing potential must agree to use specified contraception methods.
Main exclusion criteria: People without the condition or those from certain vulnerable populations may not be able to participate. Specific age restrictions apply.
Study focus: The trial lasts for 6 weeks, during which participants will use either Nacystelyn or a placebo inhaler. Researchers will monitor changes in breathing patterns, oxygen levels, and sleep quality to determine if the medication effectively reduces symptoms.
Study of sulthiame combined with oral appliance therapy for patients with obstructive sleep apnea who have incomplete response to oral appliance treatment alone
This study is specifically for people who are already using an oral appliance to treat their sleep apnoea but are not getting complete relief. Researchers want to find out if adding sulthiame, a medication that inhibits an enzyme called carbonic anhydrase, can improve results.
Main inclusion criteria: You must already be using oral appliance therapy but still have an AHI score of 15 or higher. You need to be between 18 and 75 years old and able to understand instructions, fill out questionnaires, and follow study procedures.
Main exclusion criteria: People with severe sleep apnoea, known allergies to sulthiame, kidney stones or severe kidney problems, pregnancy or breastfeeding, significant liver disease, uncontrolled high blood pressure, history of seizures, or those who work regular night shifts cannot participate.
Study focus: This is a crossover study where participants will receive both sulthiame and placebo at different times, each for 2 weeks, while continuing to use their oral appliance. Sleep studies will be conducted after each treatment period to measure breathing patterns and oxygen levels.
Study on the Effect of Aprepitant on Aldosterone Levels in Patients with Obstructive Sleep Apnea and High Blood Pressure
This trial is investigating aprepitant, a medication that blocks certain receptors involved in hormone production. The study focuses on patients who have both sleep apnoea and high blood pressure, examining whether the medication can influence aldosterone levels, a hormone that affects blood pressure.
Main inclusion criteria: Adults aged 18 to 75 with severe sleep apnoea (AHI of 30 or more) and high blood pressure can participate. Your blood pressure should be 140/90 mmHg or higher. If you’re taking diuretics, you’ll need to switch to another type of blood pressure medication before starting. Women of childbearing age must use effective contraception and have negative pregnancy tests.
Main exclusion criteria: Pregnant or breastfeeding women, people with other medical conditions that might interfere with the study, those taking medications that could affect results, individuals with allergies to the study medication, or those who recently participated in another trial cannot join.
Study focus: Participants will take aprepitant in capsule form, and researchers will monitor aldosterone levels, blood pressure, and various hormone and electrolyte measurements throughout the study to assess how the medication affects these factors.
Study on the Effectiveness of Orforglipron for Patients with Obstructive Sleep Apnea and Obesity or Overweight
This trial is testing orforglipron, a medication targeting metabolic pathways, in people who have sleep apnoea and are also overweight or have obesity. The study aims to see if taking this medication once daily can reduce the frequency of breathing interruptions during sleep.
Main inclusion criteria: You must have an AHI of 15 or higher and a BMI of 27 kg/m² or more. The study includes two groups: people who cannot or do not want to use PAP therapy (and have not used it for at least 4 weeks before screening), and those already using PAP therapy for at least 3 consecutive months who plan to continue during the study.
Main exclusion criteria: People without sleep apnoea, those who are not overweight or obese, or individuals outside the specified age range cannot participate.
Study focus: This is a double-blind trial lasting up to 52 weeks. Participants will be randomly assigned to receive either orforglipron or a placebo capsule once daily. Regular assessments will monitor changes in the Apnea-Hypopnea Index and other health indicators to evaluate the medication’s effectiveness.
Summary
These four clinical trials represent diverse approaches to treating obstructive sleep apnoea syndrome across Europe. The studies are concentrated in Western and Northern European countries, with France participating in two trials. Three of the four trials focus on patients with specific additional conditions: two target those with weight-related issues, and one addresses patients with high blood pressure. Notably, one trial specifically aims to help people who have not achieved adequate relief from existing oral appliance therapy. The investigational treatments include inhaled medications, carbonic anhydrase inhibitors, hormone-affecting drugs, and metabolic medications, reflecting the variety of biological pathways researchers are exploring to address this sleep disorder.
