Burden of Illness in Central Disorders of Hypersomnolence
Research type
Research Study
Full title
Burden of Illness Study among Patients with Central Disorders of Hypersomnolence in 6 European Countries.
IRAS ID
325690
Contact name
Gisela Kobelt
Contact email
Sponsor organisation
Takeda Pharmaceuticals
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
Central hypersomnolence disorders, including narcolepsy type 1 and 2 and idiopathic hypersomnia (NT1, NT2, IH) are rare, chronic, and disabling disorders associated with dysregulation of sleep and wakefulness. These conditions are associated with increased direct medical costs, in particular also related to productivity loss. Quality of life is substantially impaired.
The aim of the study is to quantify the burden of NT1, NT2 and IH in relation to disease severity by assessing quality of life (utility) and direct and indirect costs in six European countries.
The study is a cross-sectional, observational, quantitative survey among patients, who will be invited to participate by their clinic or their patient organisation. Data will be collected through a questionnaire covering: demographics, education, income, diagnosis, age at onset and symptoms including cataplexy, fatigue, cognition, co-morbidities, employment and work capacity, vehicle driving, health care resource utilization, pharmacological treatment and informal care. In addition, the following validated instruments will be administered: EuroQoL (EQ-5D-5L), Epworth Sleepiness Scale (ESS), Narcolepsy Severity Scale (NSS-CT) and the Idiopathic Hypersomnia Severity Scale (IHSS).
Participants will have to self-declare their diagnosis, be 18 years or older, read and understand English, accept to participate and not currently be participating in a clinical trial.
Data will be collected by electronic and mail questionnaires at one time point. Responses are entirely anonymous and cannot be traced back to an individual. Study participation will not impact treatment or other clinical decisions in any way.REC name
South Central - Berkshire Research Ethics Committee
REC reference
23/SC/0124
Date of REC Opinion
6 Apr 2023
REC opinion
Favourable Opinion