The Effectiveness of Circadin in Improving Quality of Sleep in Patients Aged 55 or Over

Open-label, Post-marketing Observational Study to Evaluate the Effectiveness of Circadin in Improving Quality of Sleep in Patients Aged 55 or Over

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02321449

Acronym

QUALISLEEP

Enrollment

Registered

2014-12-22

Start date

2014-06-30

Completion date

2015-02-28

Last updated

2019-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia

Brief 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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

55 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Change from baseline in quality of sleep questionnaire	Baseline, 3 weeks	Sleep improvement as assessed by the modified Questionnaire Scoring Subjective Characteristics of Sleep before and after treatment.

Secondary

Measure	Time frame
Change from baseline in attention Questionnaire	Baseline, 3 weeks
Change from baseline in memory Questionnaire	Baseline, 3 weeks
Percentage of patients responding unsatisfied, effective therapy, very effective therapy, respectively, in the patient satisfaction assessment	3 weeks

Countries

Russia

Outcome results