Clinical trial NCT05150977: Idiopathic Hypersomnia
Official title: Idiopathic Hypersomnia - a Retrospective Characterization Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypersomnia, Idiopathic
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible subjects are 185 individuals with idiopathic hypersomnia (IH) assessed and diagnosed using polysomnography and multiple sleep latency test at the Sleep unit, Uppsala university hospital between 2010-01-01 and 2019-12-31. Inclusion criteria is IH, according to the ICSD-3.

Brief summary: Idiopathic hypersomnia (IH) is characterized by non-restoring night-time sleep, excessive daytime sleepiness, sleep inertia, impaired cognitive functioning and autonomic symptoms. IH seems to be long lasting, once established, but little is known about long-time consequences, and research on the relationship between idiopathic hypersomnia and all-cause mortality is however sparse. IH is thus a poorly characterized disorder of hypersomnolence, and the present study aims to answer the following research questions:

1. Are there subgroups within the IH-group, that can be retrospectively characterized out of data from polysomnography, PSG and MSLT.
2. What are the relationships between IH, and possible IH subgroups, and morbidity, mortality, and sick leave, using retrospective register data?
3. What is the natural course of IH, and possible IH subgroups, assessed with questionnaires that measures daytime sleepiness, depression, and insomnia?
4. How do subjects diagnosed with IH think about their disease, cope with it, and perceive the effects of treatments, using qualitative interviews? 185 individuals assessed and diagnosed at the Sleep unit, Uppsala university hospital between 2010-01-01 and 2019-12-31 will be contacted. After collecting informed consents, PSG and MSLT data will be analysed together with register data regarding morbidity, mortality, sick leave, and pharmacotherapy.Questionnaires used at the time of the original assessment will be reviewed and, to study the natural course of the syndrome, the same questionnaires will be sent to the participants by mail.


Eligibility criteria: Inclusion Criteria:

* Idiopathic hypersomnia, according to the The International Classification of Sleep Disorders - Third Edition (ICSD-3)

Exclusion Criteria:

* Other serious somatic or psychiatric disease
* Drug additction with drug seeking behaviour

Primary outcomes:
measure: Polysomnography
timeFrame: Baseline
measure: Multiple sleep latency test
timeFrame: Baseline
Secondary outcomes:
measure: Morbidity
timeFrame: 1 week
measure: Sick leave
timeFrame: 1 week
measure: Pharmacotherapy
timeFrame: 1 week
measure: Epworth Sleepiness Scale
timeFrame: Baseline
measure: Sleep Problem Acceptance Questionnaire
timeFrame: 1 week
measure: Insomnia Severity Index
timeFrame: Baseline
measure: Montgomery Åsberg Depression Rating Scale
timeFrame: Baseline
measure: Diurnal Type Questionnaire
timeFrame: Baseline
measure: Munich Parasomnia Screening
timeFrame: Baseline
measure: The Ullanlinna Narcolepsy Scale
timeFrame: Baseline
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University
Study officials:
affiliation: Uppsala University
name: Rolf Karlsten, PhD
role: STUDY_CHAIR
References: