Real-World Observational Study on Patient-Reported Outcomes in the Treatment of Insomnia with Daridorexant in Canada
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: June 20, 2024
Actual date on which the first participant was enrolled.Participating physicians will identify potential participants based on their medical judgment for a new prescription of QUVIVIQ® (daridorexant) 50 mg. Physicians will discuss with the potential participant in person to briefly describe the study (purpose, confidentiality, questionnaires, as well as compensation). Potential participants interested in participating in the study will be asked to give their authorization to share with the PROxy Network their contact information by signing an authorization form. A designated PROxy team member will then contact the potential participant to explain the study in more details and to assess the eligibility. If the potential participant agrees to participate and provides verbal consent, he/she will be invited to visit the Participant Portal on the PROxy website to sign the ICF and complete the online baseline questionnaires. Five days prior to each study timepoint (1 month, 2 months and 3 months following baseline questionnaire completion), participants will receive an email inviting them to fill their study questionnaires. This e-mail will be sent every other day to the participant who have not completed the questionnaires. In the case where a participant has not completed the questionnaires within a period of 5 days after the first email was sent, a call will be made by a designated PROxy team member to remind the patient to complete the questionnaire. Participants who don't complete the questionnaires in the 5 days following the call will be excluded from this timepoint analysis.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.100 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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary 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
PROxy Network, an initiative of PeriPharm inc.
Montreal, CanadaOpen PROxy Network, an initiative of PeriPharm inc. in Google Maps