Daridorexant's Impact on Sleep in Chronic Insomnia
Data Collection
Collected from today forward - ProspectiveMental Disorders+3
+ Sleep Initiation and Maintenance Disorders
+ Nervous System Diseases
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: October 1, 2023
Actual date on which the first participant was enrolled.This study explores how well the medication daridorexant works for people with chronic insomnia, a condition that affects about 10% of the European population. Insomnia can lead to serious health issues like heart disease, depression, and diabetes. Daridorexant has been recommended in European guidelines as a first-choice treatment for insomnia because it avoids some side effects common with other sleep aids, such as feeling drowsy during the day or becoming dependent on the drug. By using a modern approach, this study aims to measure daridorexant's effectiveness in real-world settings compared to other treatments and identify which patients benefit the most from it. Participants in the study will take daridorexant 50 mg and their sleep quality will be monitored over three months. This will be done through self-reported questionnaires and a wearable device that tracks sleep patterns based on movement. The study will assess improvements in sleep quality, how long and efficiently people sleep, and how well they function during the day. By looking at these factors, researchers hope to understand how daridorexant helps with sleep and whether it can also alleviate symptoms of other sleep disorders. Potential risks are not highlighted, suggesting the focus is on evaluating positive outcomes and understanding the medication's effectiveness in real-life conditions.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.31 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Age ≥ 18 years * Signed informed consent form * Diagnosis of chronic insomnia according to DSM-5 criteria, defined as: Dissatisfaction with sleep quantity or quality, associated with one or more of the following: Difficulty initiating sleep Difficulty maintaining sleep (frequent awakenings or trouble returning to sleep) Early morning awakenings with inability to return to sleep The sleep disturbance causes clinically significant distress or impairment in social, occupational, educational, academic, or other important areas of functioning Sleep difficulties occur despite adequate opportunity and circumstances for sleep The insomnia is not better explained by or occurring exclusively during other sleep-wake disorders (e.g., narcolepsy, parasomnias, circadian rhythm sleep-wake disorders, breathing-related sleep disorders) The insomnia is not attributable to the physiological effects of a substance (e.g., drug abuse or medication) \- No contraindications to daridorexant use according to the European Medicines Agency (EMA) Exclusion Criteria: * Pregnancy * Breastfeeding * Withdrawal of informed consent at any time
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Azienda Ospedaliera Universitaria Pisana
Pisa, ItalyOpen Azienda Ospedaliera Universitaria Pisana in Google Maps