Study on Daridorexant for Treating Insomnia in Patients with Insomnia and Nocturia

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What is this study about?

This clinical trial is focused on studying the effects of a medication called daridorexant in individuals who have insomnia and a condition known as nocturia. Insomnia is a sleep disorder where people have trouble falling asleep or staying asleep, while nocturia is a condition where individuals wake up frequently during the night to urinate. The study aims to determine if daridorexant can help improve sleep in people who experience both of these conditions.

Participants in the study will receive either the medication QUVIVIQ, which contains daridorexant, or a placebo, which looks like the medication but does not contain the active ingredient. The study is designed to be a double-blind, randomized, placebo-controlled trial, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo during the study period. This helps ensure that the results are unbiased and reliable.

The study will take place over several weeks, during which participants will be monitored to see how their sleep patterns change. The main goal is to assess whether daridorexant can increase the total amount of sleep time for those with insomnia and nocturia. Participants will be asked to report their sleep experiences, and researchers will analyze this information to determine the effectiveness of the treatment. The study is expected to provide valuable insights into managing sleep disorders in individuals with these conditions.

1 initial visit

Upon joining the study, you will have an initial visit with the study team. During this visit, you will be asked to sign an informed consent form (ICF) to confirm your understanding and agreement to participate in the study.

You will undergo an assessment to ensure you meet the study criteria, which includes being at least 55 years old, having insomnia complaints for at least 3 months, and experiencing nocturia with an average of 3 or more nighttime bathroom visits.

2 randomization

After the initial assessment, you will be randomly assigned to one of two groups. This process is called randomization. You will either receive the study medication, daridorexant, or a placebo, which looks like the medication but has no active ingredients.

The study is double-blind, meaning neither you nor the study team will know which group you are in during the trial.

3 medication administration

You will take the assigned medication orally in the form of film-coated tablets. If you are in the daridorexant group, you will receive QUVIVIQ 50 mg tablets.

The medication should be taken once daily, following the instructions provided by the study team.

4 follow-up visits

Throughout the study, you will have regular follow-up visits with the study team. These visits are important to monitor your health and the effects of the medication.

During these visits, you will be asked about your sleep patterns and any changes in your nocturia symptoms.

5 end of study assessment

At the end of the study, you will have a final assessment. This will include a review of your overall experience and any changes in your sleep and nocturia symptoms.

The primary goal is to evaluate the change in your total sleep time from the beginning of the study to the end of the fourth week.

Who Can Join the Study?

Must have signed and dated the informed consent form before any study-related procedures. This means you agree to participate and understand what the study involves.
Must be a male or female who is 55 years old or older at the time of signing the consent form.
Must have had trouble sleeping, known as insomnia, for at least 3 months before the first study visit.
Must have an Insomnia Severity Index (ISI) score of 13 or higher at the first study visit. The ISI is a questionnaire that helps measure how severe your insomnia is.
Must experience nocturia, which means waking up at night to urinate, with an average of 3 or more times per night for at least 1 month before the first study visit.
Must be able to communicate well with the study doctor, understand the study requirements, and be alert and aware of who you are, where you are, the time, and the situation.

Who Cannot Join the Study?

Patients who are not diagnosed with Insomnia Disorder cannot participate.
Patients who do not have Nocturia cannot participate. Nocturia is a condition where you wake up during the night because you have to urinate.
Patients who are under 18 years old cannot participate.
Patients who are over 65 years old cannot participate.
Patients who are part of a vulnerable population cannot participate. This means groups of people who might need special protection or care.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Somni bene Institut fuer medizinische Forschung und Schlafmedizin Schwerin GmbH	Schwerin	Germany
Urologicum Duisburg	Duisburg	Germany
Advanced Sleep Research GmbH	Berlin	Germany
Hospital Universitario De Canarias	La Laguna	Spain
Hospital Universitario Puerta Del Mar	Cadiz	Spain
Hospital Del Mar	Barcelona	Spain
Uroclinica Barcelona SLP	Barcelona	Spain
Glegudvxsyfzahsgjin Mkzwjto Bhqjq &xsjp Hdef Sshhevck	Duisburg	Germany
Urffbtlfxqu Phcemlpfhaulimxnoy &xskyhy Pkxdiaitbymw am Fqayjgeidqvvhpjomy	Aachen	Germany
Flwlgahtp Pyrm Le Irqnpttiukgpv Bjkwdjifs Dww Hdzprgxe Uzijtmlbmdzgj Lh Paw	Madrid	Spain
Hnzvnytr Uhtgytofdqezu dl A Cmfmll	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	06.03.2023
Spain	Not recruiting	06.03.2023

Trial locations

Investigated drugs:

Daridorexant

Daridorexant is a medication used in this clinical trial to help people who have trouble sleeping, a condition known as insomnia. 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. This trial is specifically looking at how well daridorexant can help people who not only have insomnia but also experience frequent urination at night, a condition called nocturia. The goal is to see if this medication can improve sleep quality for these individuals.

Investigated diseases:

Insomnia Disorder – Insomnia Disorder is characterized by difficulty in falling asleep, staying asleep, or waking up too early and not being able to return to sleep. This condition often leads to daytime fatigue, mood disturbances, and impaired cognitive function. It can be a short-term issue or a chronic problem lasting for months or longer. The progression of insomnia can vary, with some individuals experiencing intermittent episodes, while others may have persistent symptoms. Factors such as stress, lifestyle habits, and underlying health conditions can influence its development. Over time, chronic insomnia can affect overall health and quality of life.

Nocturia – Nocturia is a condition where an individual wakes up during the night one or more times to urinate. It is often associated with an increased volume of urine production at night or a reduced bladder capacity. This condition can disrupt sleep patterns and lead to fatigue and decreased alertness during the day. Nocturia can be caused by various factors, including age-related changes, lifestyle habits, or underlying medical conditions. The frequency and severity of nocturia can vary, with some individuals experiencing occasional episodes and others having more frequent occurrences. Over time, it can impact sleep quality and overall well-being.

Trial ID:

2022-501246-30-00

Protocol code:

ID-078A401

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Daridorexant for Treating Insomnia in Patients with Insomnia and Nocturia

What is this study about?

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