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Study on Daridorexant's Effect on Cognitive Performance in Patients with Chronic Insomnia Disorder

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called daridorexant on people with chronic insomnia disorder. Chronic insomnia is a condition where individuals have trouble falling asleep or staying asleep for a long period. The medication being tested is known as QUVIVIQ, which comes in the form of 50 mg film-coated tablets. The purpose of the study is to confirm how effective daridorexant is in improving sleep and daytime symptoms in patients with chronic insomnia.

Participants in the study will take daridorexant daily as part of their regular treatment. The study will monitor changes in their sleep patterns and daytime symptoms over a period of six months. This will include visits at three months and six months to assess how the medication is working. During these visits, changes in sleep quality and cognitive performance, such as attention and memory, will be evaluated using simple tests and questionnaires.

The study aims to provide a better understanding of how daridorexant can help improve sleep and daily functioning in people with chronic insomnia. By observing changes in sleep and cognitive performance, researchers hope to gather valuable information on the benefits of this treatment for those affected by this sleep disorder.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initiation of treatment
Begin taking daridorexant 50 mg once daily. This medication is in the form of a film-coated tablet and is taken orally.
The treatment is intended for individuals diagnosed with chronic insomnia disorder.
Step 2
First follow-up visit
Attend a follow-up visit after 3 months of starting the medication.
During this visit, changes in the insomnia severity index (ISI) total score will be assessed.
Subjective total sleep time (sTST) will be measured using a sleep diary for the 7 days prior to the visit.
Step 3
Second follow-up visit
Attend a second follow-up visit after 6 months of starting the medication.
Similar to the first follow-up, changes in the ISI total score and sTST will be evaluated.
Additional assessments will include changes in cognitive performance, attention, and memory through neuropsychological tests.
Step 4
Additional assessments
At both the 3-month and 6-month follow-up visits, further evaluations will be conducted.
These include changes in the Pittsburgh Sleep Quality Index (PSQI) scores, Epworth Sleepiness Scale (ESS) scores, and Morningness-Eveningness Questionnaire (MEQ) scores.
Changes in the Beck Depression Inventory-II total score and the mental and physical components of the SF-12 will also be assessed.

Who can join the trial?

7 criteria

Patients must be **male or female**.
Patients must be **18 years or older** but **younger than 65 years**.
Patients must have a diagnosis of **chronic insomnia disorder**. This means they have trouble sleeping for a long time, as defined by a specific guideline called **ICSD-3**.
Patients must be starting a medication called **daridorexant** at a dose of **50 mg per day**. This should be according to the approved instructions for use.
Patients must be able and willing to **give written informed consent**. This means they agree to participate in the study after understanding what it involves.
Patients must be willing and able to **understand the purpose of the study**, including any possible risks and side effects.
Patients must be willing and able to **follow the study requirements**. This means they agree to do what is needed for the study.

Who cannot join the trial?

7 criteria

Patients who are not diagnosed with chronic insomnia cannot participate. Chronic insomnia is a condition where a person has trouble sleeping for a long period.
Patients who are under 18 years old cannot participate.
Patients who are part of a vulnerable population, such as those who cannot make decisions for themselves, cannot participate.
Patients who are not willing to follow the study procedures cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients who have a known allergy or sensitivity to the study medication cannot participate.
Patients who have a medical condition that the study doctors believe would make it unsafe for them to participate cannot participate.

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Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA
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Rome, Italy

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Investigated drugs

Daridorexant is a medication being studied for its effectiveness in improving cognitive performance in patients with chronic insomnia disorder. It is used to help people with insomnia get better sleep and improve their daytime functioning. The study aims to confirm how well this medication works in real-world settings over a period of three to six months.

Daridorexant

What is already known about the treatment

Daridorexant – This medication is taken orally and is used to help people with chronic insomnia, a condition where individuals have trouble sleeping. It is currently being studied in clinical trials to confirm its effectiveness in real-world settings. The main purpose of daridorexant is to improve sleep quality and reduce daytime symptoms associated with insomnia. It works by blocking certain receptors in the brain that promote wakefulness, helping to regulate the sleep-wake cycle. Daridorexant is classified as a dual orexin receptor antagonist, which means it targets specific proteins involved in keeping you awake.

Investigated diseases

Chronic Insomnia Disorder – Chronic insomnia disorder is a condition characterized by difficulty falling asleep, staying asleep, or waking up too early, leading to inadequate sleep quality or quantity. This condition persists for at least three nights per week and lasts for three months or longer. Individuals with chronic insomnia often experience daytime symptoms such as fatigue, mood disturbances, and impaired concentration. The disorder can affect daily functioning and overall quality of life. It is not considered a rare disease and can occur in people of all ages.