Observational, Multicentre, Cross-sectional Study to Describe Diagnosis and Treatment Patterns in Narcolepsy Patients in Real Life Practice in Spain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- Percentage of Participants Categorized Based on Treatment by Narcolepsy Type Since Diagnosis up to Study Visit
研究概览
简要总结
This study aims to review information of people with a sleep condition called narcolepsy. Narcolepsy is a condition that causes extreme sleepiness during the day including falling asleep suddenly. Study doctors will review the medical records of the participants from sleep clinics in Spain. They will do this from 1 year before the participant was diagnosed with narcolepsy up to the start of this study.
Participants will visit the sleep clinic once. During this visit, the study doctors will carry out a short medical exam. Participants will also complete a few questionnaires during this visit. If participants cannot visit the clinic for any reason, the clinic staff will arrange a phone call instead.
详细描述
This is a non-interventional, cross-sectional study with retrospective medical chart review conducted in public and private Spanish sleep clinics, to describe the management of adult participants diagnosed with narcolepsy defined by ICDS-3 in real world practice.
This study will enroll approximately 196 participants (137 with NT1 and 59 with NT2). Participants will be enrolled in 2 cohorts:
- Cohort A: NT1 Participants
- Cohort B: NT2 Participants
The data will be collected retrospectively through clinical records and at study visit (clinical and demographic data, and participant related outcomes [PRO]) in an electronic case report form (eCRF).
This multi-center study will be conducted in Spain. The overall duration of this study is approximately 24 months. Participants will attend a single visit in the participating centers. In the event of a possible outbreak of coronavirus disease 2019 (COVID-19) participants will have a telepathic visits, the invitation to participate, the obtention of participant's informed consent and the collection of participant's questionnaires will be carried out remotely (by phone or via email).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •With confirmed diagnosis of narcolepsy defined by ICDS-
- •With at least 1-year follow-up with data available at the participating site after initial narcolepsy diagnosis and before study inclusion.
- •With data available at the participant site at least 1-year before first narcolepsy diagnosis.
- •Capable to fulfill the study questionnaires.
排除标准
- •Participating in a clinical trial (less than or equal to [<=] 12 months).
- •With any serious degenerative disease (Alzheimer, Parkinson or epilepsy) or psychiatric condition.
结局指标
主要结局
Percentage of Participants Categorized Based on Treatment by Narcolepsy Type Since Diagnosis up to Study Visit
时间窗: From narcolepsy diagnosis up to study visit (up to 12 months)
Percentage of participants with narcolepsy categorized based on pharmacological and non-pharmacological treatment as 'yes' and 'no' since study diagnosis are reported in this outcome measure. Percentages are rounded-off to the nearest decimal point.
Percentage of Participants Categorized Based on Non-Pharmacological Treatments Patterns by Treatment Status
时间窗: From narcolepsy diagnosis up to study visit (up to 12 months)
Percentage of participants with narcolepsy categorized based on non-pharmacological treatment patterns as 'yes' and 'no' by treatment status \[Naïve (untreated) and treated\] are reported in this outcome measure. Percentages are rounded-off to the nearest decimal point. Data is collected and reported per Naïve (untreated) and treated arms for this outcome measure.
Percentage of Treated or Naïve (Untreated) Participants for the Type of Pharmacological Treatment Status Since Diagnosis
时间窗: From narcolepsy diagnosis up to study visit (up to 12 months)
Percentage of Treated or naïve (Untreated) participants with narcolepsy categorized based on pharmacological treatment status since diagnosis are reported in this outcome measure. Percentages are rounded-off to the nearest decimal point.
Percentage of Participants With the Use of Each Type of Treatment Stratified by Type of Hospital (Public or Private Centers)
时间窗: From a year before narcolepsy diagnosis up to study visit (up to 20 months)
Percentages are rounded off to the nearest decimal point.
次要结局
- Number of Participants Categorized by Sociodemographic and Clinical Variables at Study Visit(Day 1)
- Height of Participants at Study Visit(Day 1)
- Weight of Participants at Study Visit(Day 1)
- Body Mass Index (BMI) of Participants at Study Visit(Day 1)
- Blood Pressure (BP) of Participants at Study Visit(Day 1)
- Percentage of Participants Categorized Based on Different Specialists Who Diagnosed Narcolepsy(From a year before narcolepsy diagnosis up to study visit (up to 20 months))
- Percentage of Participants Categorized Based on Usage of Different Procedures or Tests for the Diagnosis of Narcolepsy(From a year before narcolepsy diagnosis up to 12 months)
- Time From First Symptom to Diagnosis of Narcolepsy(From first symptom of narcolepsy up to diagnosis maximum up to 59.92 years (retrospective data was retrieved and observed during 20 months of this study))
- Time From Diagnosis of Narcolepsy to First Treatment(From first symptom of narcolepsy up to diagnosis maximum up to 46.04 years (retrospective data was retrieved and observed during 20 months of this study))
- Percentage of Participants Categorized Based on Pharmacological Treatment and Interventions Received in Relation With the Presence of Most Typical Symptoms(From a year before narcolepsy diagnosis up to study visit (up to 20 months))
- Percentage of Participants With Pharmacological Treatments at Each Line(From a year before narcolepsy diagnosis up to study visit (up to 20 months))
- Sustained Attention to Response Task (SART)(From a year before narcolepsy diagnosis up to study visit (up to 20 months))
- Maintenance of Wakefulness Test (MWT)(From a year before narcolepsy diagnosis up to study visit (up to 20 months))
- Epworth Sleepiness Scale (ESS)(From a year before narcolepsy diagnosis up to 12 months)
- Percentage of Participants Categorized Based on Different Non-pharmacological Treatment Approach(From a year before narcolepsy diagnosis up to study visit (up to 20 months))
- Percentage of Participants Categorized Based on Utilization of Direct Healthcare Resource Utilized Per Year(From a year before study visit (up to 12 months))
- Duration of Hospitalization(From a year before study visit (up to 12 months))
- Work Productivity and Activity Impairment (WPAI) Score(From a year before study visit (up to 20 months))
- Number of Participants Categorized Based on Occupational Accidents(From a year before study visit (up to 20 months))
- Percentage of Participants Categorized Based on Cost of Direct Healthcare Resources Utilized by Participants Per Year(From a year before study visit (approximately 20 months))
- Percentage of Participants With Health Related Quality of Life (HRQoL) Assessed by European Quality of Life Five Dimension (EQ-5D) Questionnaire(From a year before narcolepsy diagnosis up to study visit (up to 20 months))
- Stigma Scale for Chronic Illness 8-item Version (SSCI-8) Total Score(From a year before narcolepsy diagnosis up to study visit (up to 20 months))
- Treatment Satisfaction of Participants Assessed by Treatment Satisfaction Questionnaire for Medication (TSQM-9)(From a year before narcolepsy diagnosis up to study visit (up to 20 months))
- Percentages of Participants Based on Most Prevalent Comorbidities and Other Concomitant Disorders Associated With Narcolepsy(From a year before narcolepsy diagnosis up to study visit (up to 20 months))
- Charlson Comorbidity Index (CCI)(From a year before narcolepsy diagnosis up to study visit (up to 20 months))
- Number of Participants With Adverse Events (AEs)(Up to 20 months)