Clinical trial NCT06311864: Real-World Observational Study on Patient-Reported Outcomes in the Treatment of Insomnia with Daridorexant in Canada
Official title: Real-World Observational Study on Patient-Reported Outcomes in the Treatment of Insomnia with Daridorexant in Canada
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Insomnia
Keywords: daridorexant
dual orexin receptor antagonist
real-world
observational
quality of life
work productivity
insomnia
Lead sponsor: PeriPharm
Sponsor class: OTHER
Collaborators: name: Idorsia Pharmaceuticals Ltd.
First posted: 2024-03-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible patients identified by 10 participating physicians in 4 provinces across Canada (Quebec, Ontario, Alberta, British Columbia)

Brief summary: The purpose of this observational study is to evaluate the impact of daridorexant on quality of life, work productivity and insomnia symptoms in Canadian adults suffering from insomnia.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Signed ICF prior to any study-mandated procedure.
* Has received a first prescription of daridorexant 50 mg to treat insomnia, treatment start has not exceeded 7 days prior to enrollment.
* Ability to read and understand French or English.

Exclusion Criteria:

* Patients participating in a clinical trial.
* History of daridorexant use in the past (i.e., samples provided by the physician before prescription).
* Taking a concomitant medication to treat insomnia.
* Already started daridorexant more than 7 days prior to enrollment.The 7-day period is necessary to allow flexibility between the time of prescription and PROxy first contact to participant. Beyond this 7-day period, patients may already have experienced benefits from daridorexant. To minimize bias in baseline results, these patients will be excluded.

Primary outcomes:
measure: Change from Baseline in Quality of Life
timeFrame: Month 1, Month 2, Month 3
measure: Change from Baseline in Work Productivity Loss
timeFrame: Month 1, Month 2, Month 3
measure: Change from Baseline in the Severity of Insomnia Symptoms
timeFrame: Month 1, Month 2, Month 3
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: PROxy Network, an initiative of PeriPharm inc.
state: Quebec
Study officials:
affiliation: PeriPharm
name: Jean Lachaine, PhD
role: PRINCIPAL_INVESTIGATOR
References: