Ongoing Clinical Trials for Nocturia
This article provides information about an ongoing clinical trial investigating treatments for nocturia, a condition where people wake up frequently during the night to urinate. Currently, there is 1 clinical trial being conducted in Europe, testing the medication daridorexant in patients who experience both nocturia and insomnia.
Clinical trial locations
- Germany
- Spain
Study on Daridorexant for Treating Insomnia in Patients with Insomnia and Nocturia
This clinical trial is investigating how the medication daridorexant can help people who suffer from both insomnia and nocturia. Insomnia is a sleep disorder where people have difficulty falling asleep or staying asleep, while nocturia causes people to wake up frequently during the night to use the bathroom. The study aims to find out whether daridorexant can improve sleep quality and increase total sleep time for individuals experiencing both conditions.
Who can participate:
- Adults who are 55 years old or older
- People who have experienced insomnia for at least 3 months
- Those with an Insomnia Severity Index score of 13 or higher, indicating moderate to severe sleep problems
- Individuals who wake up 3 or more times per night to urinate, with this pattern lasting at least 1 month
- People who can communicate well with the study team and understand the study requirements
Who cannot participate:
- People under 18 years old or over 65 years old
- Those who are not diagnosed with insomnia disorder
- Those who do not experience nocturia
- Individuals who are part of vulnerable populations that may need special protection or care
What the study involves:
This is a double-blind, randomized, placebo-controlled trial, which means that neither participants nor researchers will know who is receiving the actual medication or a placebo (an inactive substance that looks like the medication). This design helps ensure that the results are unbiased and reliable.
Participants will receive either QUVIVIQ 50 mg tablets, which contain daridorexant, or a placebo. The medication is taken once daily in the form of film-coated tablets. Throughout the study, participants will have regular follow-up visits where the study team will monitor their health and ask about changes in sleep patterns and nighttime bathroom visits.
How the medication works:
Daridorexant is classified as a dual orexin receptor antagonist. It works by blocking certain signals in the brain that can keep you awake, helping you to fall asleep more easily and stay asleep longer. The medication targets specific proteins in the brain to help regulate the sleep-wake cycle.
Main goal of the trial:
The primary objective is to evaluate whether daridorexant can increase the total amount of sleep time for people with both insomnia and nocturia. The study will measure the change in total sleep time from the beginning of the study to the end of the fourth week. Researchers will analyze participants’ reported sleep experiences to determine the effectiveness of the treatment.
The trial is being conducted in Spain and Germany and is expected to provide valuable insights into managing sleep disorders in individuals who experience both insomnia and frequent nighttime urination.
Summary
Currently, there is one active clinical trial focused on nocturia, specifically targeting patients who also suffer from insomnia. The trial is being conducted in two European countries: Spain and Germany. The study focuses exclusively on the investigational drug daridorexant, marketed as QUVIVIQ, which represents a relatively new approach to treating sleep disturbances by blocking signals in the brain that promote wakefulness.
This trial specifically targets older adults aged 55 and above who experience both moderate to severe insomnia and frequent nighttime urination. The combination of these two conditions can significantly impact quality of life, and this research aims to determine whether treating the sleep disorder component can provide relief for patients experiencing both issues simultaneously.
The trial uses a rigorous double-blind, placebo-controlled design, which is considered the gold standard in clinical research for evaluating treatment effectiveness. This approach helps ensure that any observed benefits are truly due to the medication rather than other factors such as expectation or natural variation in symptoms.
