InsomniaNCT06311864
Real-World Observational Study on Patient-Reported Outcomes in the Treatment of Insomnia With Daridorexant in Canada
An observational study of Insomnia, run by PeriPharm at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- Daridorexant 50 mg
- Type of treatment
- Pill or oral medicine
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- 20 Jun 2024to 19 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible patients identified by 10 participating physicians in 4 provinces across Canada (Quebec, Ontario, Alberta, British Columbia)
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
PROxy Network, an initiative of PeriPharm inc.
Montreal, Quebec, H2Y 2H4
About this study
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.
Read the 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.
- Conditions
- Insomnia
- Being tested
- Daridorexant 50 mg
- Keywords
- daridorexant, dual orexin receptor antagonist, real-world, observational, quality of life, work productivity, insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daridorexant 50 mgDrug
Also called QUVIVIQ
As indicated by the physician
| Study group | Role | What they receive |
|---|---|---|
| daridorexant | Patients who have been newly prescribed oral tablets of daridorexant 50 mg to treat their insomnia Receives: Drug: Daridorexant 50 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Month 1, Month 2, Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start20 Jun 2024
- Primary completion19 May 2026
- Study completion19 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- PeriPharm
- Sponsor type
- University, hospital or other
- Collaborators
- Idorsia Pharmaceuticals Ltd.
- Responsible party
- Principal investigator, Jean Lachaine, PeriPharm
- Investigators
- Jean Lachaine, PhD, Principal investigator, PeriPharm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06311864
- Sponsor's protocol ID
- PROxy240215
- Status last verified
- May 2026
- First submitted
- 6 Mar 2024
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Observational Study on Patient-Reported Outcomes in the Treatment of Insomnia With Daridorexant in Canada
- ClinicalTrials.gov ID
- NCT06311864
- Acronym / sponsor ID
- PROxy240215
- Conditions
- Insomnia
- Keywords
- daridorexant, dual orexin receptor antagonist, real-world, observational, quality of life, work productivity, insomnia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- PeriPharmUniversity, hospital or other
- Collaborators
- Idorsia Pharmaceuticals Ltd.
- Study start
- 20 Jun 2024 (actual)
- Primary completion
- 19 May 2026 (actual)
- Study completion
- 19 May 2026 (actual)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| daridorexant | – | Drug: Daridorexant 50 mgPatients who have been newly prescribed oral tablets of daridorexant 50 mg to treat their insomnia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients identified by 10 participating physicians in 4 provinces across Canada (Quebec, Ontario, Alberta, British Columbia)
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daridorexant 50 mgAlso: QUVIVIQAs indicated by the physician | Drug | daridorexant |
Primary outcome
Change from Baseline in Quality of Life
Time frame: Month 1, Month 2, Month 3
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.
Change from Baseline in Work Productivity Loss
Time frame: Month 1, Month 2, Month 3
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.
Change from Baseline in the Severity of Insomnia Symptoms
Time frame: Month 1, Month 2, Month 3
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Lachaine, PhD principal investigator
PeriPharm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insomnia, run by PeriPharm at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Quality of Life (time frame: Month 1, Month 2, Month 3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.