InsomniaQUALISLEEPNCT02321449
The Effectiveness of Circadin in Improving Quality of Sleep in Patients Aged 55 or Over
An observational study of Insomnia, run by Ipsen at 3 sites in Russia.
Trial summary
To evaluate the effectiveness of treatment with Circadin based on sleep improvement as assessed by the modified Questionnaire Scoring Subjective Characteristics of Sleep before and after the treatment Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Insomnia
- How many people
- 40 participants
- Where
- 3 sitesRussia
- Study dates
- Jun 2014to Feb 2015
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult male and female patients aged ≥ 55 years suffering from primary (non-organic) insomnia characterized by poor quality of sleep
Who may be able to join
- Male and female patients aged ≥ 55 years suffering from non-organic insomnia according to International Classification of Diseases (ICD-10)
- Patients with sleep disorders manifested as poor sleep quality associated with impaired daytime functioning with or without one or more of the following criteria: difficulty falling asleep, frequent night awakenings, early morning awakenings
- Patients able to follow the study protocol
- Patients who have signed the Informed Consent prior to initiation of any observation-related procedures
- Patients with a global score of ≤17 inclusively on the modified Questionnaire Scoring Subjective Characteristics of Sleep
- Patients who have just been identified to receive treatment with Circadin
- Patients without previous treatment with Circadin
Who cannot join
- Hypersensitivity to any components of Circadin
- Congenital galactose intolerance, glucose-galactose malabsorption, Lapp lactase deficiency
- Pregnancy and lactation
- Alcohol or drug addiction
- Severe somatic and neurological conditions, exacerbations thereof, including autoimmune diseases or renal/hepatic insufficiency
- Intake of psychoactive medicines within the last 30 days before observational study entry
- Presence of clinically significant anxiety and depression as assessed by the Hospital Anxiety and Depression Scale
- Presence of pain that might be the cause for insomnia. Subjects suffering from breathing related sleep disorders
Trial locations and contacts
3 sites in 1 country.
Russia3 sites
State research center of preventive medicine
Moscow, 101000
Research and Education Center of Moscow State University named after M.V. Lomonosov
Moscow, 119192
First Moscow State Medical University
Moscow, 119435
About this study
Official title: Open-label, Post-marketing Observational Study to Evaluate the Effectiveness of Circadin in Improving Quality of Sleep in Patients Aged 55 or Over
To evaluate the effectiveness of treatment with Circadin based on sleep improvement as assessed by the modified Questionnaire Scoring Subjective Characteristics of Sleep before and after the treatment
- Conditions
- Insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in quality of sleep questionnaire
Sleep improvement as assessed by the modified Questionnaire Scoring Subjective Characteristics of Sleep before and after treatment.
Measured: Baseline, 3 weeks
Secondary outcomes (3)
Change from baseline in attention Questionnaire
Measured: Baseline, 3 weeks
Change from baseline in memory Questionnaire
Measured: Baseline, 3 weeks
Percentage of patients responding "unsatisfied", "effective therapy", "very effective therapy", respectively, in the patient satisfaction assessment
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2014 (estimated)
- Study startJun 2014
- Primary completionFeb 2015
- Study completionFeb 2015
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.
- More trials run by IpsenThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02321449
- Sponsor's protocol ID
- A-38-59010-001
- Acronym
- QUALISLEEP
- Status last verified
- Jan 2019
- First submitted
- 17 Dec 2014
- Last updated
- 11 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Post-marketing Observational Study to Evaluate the Effectiveness of Circadin in Improving Quality of Sleep in Patients Aged 55 or Over
- ClinicalTrials.gov ID
- NCT02321449
- Acronym / sponsor ID
- QUALISLEEP / A-38-59010-001
- Conditions
- Insomnia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 22 Dec 2014 (estimated)
- 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.
To evaluate the effectiveness of treatment with Circadin based on sleep improvement as assessed by the modified Questionnaire Scoring Subjective Characteristics of Sleep before and after the treatment
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult male and female patients aged ≥ 55 years suffering from primary (non-organic) insomnia characterized by poor quality of sleep
Key inclusion criteria (7 listed)
- Male and female patients aged ≥ 55 years suffering from non-organic insomnia according to International Classification of Diseases (ICD-10)
- Patients with sleep disorders manifested as poor sleep quality associated with impaired daytime functioning with or without one or more of the following criteria: difficulty falling asleep, frequent night awakenings, early morning awakenings
- Patients able to follow the study protocol
- Patients who have signed the Informed Consent prior to initiation of any observation-related procedures
- Patients with a global score of ≤17 inclusively on the modified Questionnaire Scoring Subjective Characteristics of Sleep
Key exclusion criteria (8 listed)
- Hypersensitivity to any components of Circadin
- Congenital galactose intolerance, glucose-galactose malabsorption, Lapp lactase deficiency
- Pregnancy and lactation
- Alcohol or drug addiction
- Severe somatic and neurological conditions, exacerbations thereof, including autoimmune diseases or renal/hepatic insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from baseline in quality of sleep questionnaire
Time frame: Baseline, 3 weeks
Sleep improvement as assessed by the modified Questionnaire Scoring Subjective Characteristics of Sleep before and after treatment.
3 secondary outcomes
Change from baseline in attention Questionnaire
Time frame: Baseline, 3 weeks
Change from baseline in memory Questionnaire
Time frame: Baseline, 3 weeks
Percentage of patients responding "unsatisfied", "effective therapy", "very effective therapy", respectively, in the patient satisfaction assessment
Time frame: 3 weeks
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 11 Jan 2019.
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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.
Ipsen Medical Director study director
Ipsen
3 sites 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 Ipsen at 3 sites in Russia.
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 7 inclusion and 8 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 11 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Russia. 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 sleep questionnaire (time frame: Baseline, 3 weeks). 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 11 Jan 2019.