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DARIdorexant efficacy on the COGnitive performance in patients with chronic insomnia disorder. DARI-COG Study
EU CTIS ID: 2024-517768-52-00
What this study is testing
Confirm in a real-world study the effectiveness of daridorexant 50 mg/day in patients with chronic insomnia disorder, who will start the drug as common clinical practice and according to indication to monitor subjective sleep and daytime symptoms at 3 month and 6 month follow-up visit
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Male and female patients aged ≥18 years old and < 65 years old with a diagnosis of chronic insomnia disorder according to the ICSD-3; 2. Starting daridorexant 50 mg daily according to the regulatory approved indication; 3. Patients who are able and willing to give written informed consent, willing and able to understand the purpose of the study, including possible risks and side effects, and willing and able to comply with the study requirements.
You likely can't join if
- 1. Concomitant sleep disorders 2. Major psychiatric disorders 3. Patients contraindicated for daridorexant use (according to SmPC) 4. Dose adjustment of daridorexant or prescription to 25 mg/day 5. Pregnancy or planned pregnancy 6. History of suicide ideations and/or attempts 7. History of epilepsy 8. Previous cerebrovascular diseases 9. Heavy smoking 10. Shift-work 11. Use of drugs affecting cognition 12. Body Mass Index >35
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.