Real-World Observational Study on Patient-Reported Outcomes in the Treatment of Insomnia with Daridorexant in Canada

NCT06311864 | Enrolling By Invitation

• 1 other identifier: PROxy240215
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia

Keywords

daridorexant; dual orexin receptor antagonist; real-world; observational; quality of life; work productivity; insomnia

Outcome Measures

Primary Outcomes (3)

• Change from Baseline in Quality of Life

  QoL will be measured using the SF-36 questionnaire, a self-administered and validated questionnaire. The percentage change from baseline in each domain of the SF-36 will be assessed at Month 1, Month 2 and Month 3.

  Month 1, Month 2, Month 3

• Change from Baseline in Work Productivity Loss

  Work productivity loss will be measured using the Work Productivity and Activity Impairment for Specific Health Problem (WPAI:SHP), a self-administered and validated 6-item questionnaire designed to assess the impact of a health condition on work productivity and daily activities for a specific disease/condition (in this case, insomnia). The percentage change from baseline on the WPAI:SHP score at month 1, month 2 and month 3 will be assessed.

  Month 1, Month 2, Month 3

• Change from Baseline in the Severity of Insomnia Symptoms

  Severity of insomnia symptoms will be measured using the Insomnia Severity Index (ISI) questionnaire, a self-administered, validated, 7-item questionnaire, designed to assess the severity of insomnia symptoms. The ISI will be assessed at Month 1, Month 2, and Month 3.

  Month 1, Month 2, Month 3

Study Arms (1)

daridorexant

Patients who have been newly prescribed oral tablets of daridorexant 50 mg to treat their insomnia

Drug: Daridorexant 50 mg

Interventions

Daridorexant 50 mg DRUG

As indicated by the physician

Also known as: QUVIVIQ

daridorexant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible patients identified by 10 participating physicians in 4 provinces across Canada (Quebec, Ontario, Alberta, British Columbia)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• PeriPharm: lead
• Idorsia Pharmaceuticals Ltd.: collaborator

Study Sites (1)

PROxy Network, an initiative of PeriPharm inc.

Montreal, Quebec, H2Y 2H4, Canada

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

daridorexant

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Jean Lachaine, PhD

  PeriPharm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 15, 2024
• Study Start: June 20, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)