MedPath

Idiopathic Hypersomnia

Completed
Conditions
Hypersomnia, Idiopathic
Interventions
Other: Polysomnography
Registration Number
NCT05150977
Lead Sponsor
Uppsala University
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
69
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Idiopathic hypersomniaPolysomnographyObservation
Primary Outcome Measures
NameTimeMethod
PolysomnographyBaseline

Spectral analyses

Multiple sleep latency testBaseline

Sleep latency and REM latency

Secondary Outcome Measures
NameTimeMethod
Insomnia Severity IndexBaseline

Score on a scale. Seven items with a total score ranging from 0 to 28 points. Higher values means more severe insomnia, a negative outcome.

Diurnal Type QuestionnaireBaseline

Score on a scale. The overall score ranges 0 to 21, and higher scores equals more of a delayed sleep phase.

The Ullanlinna Narcolepsy ScaleBaseline

Score on a scale. 11 item with a total score ranging 0-44. Higher total score equals a negative outcome.

Munich Parasomnia ScreeningBaseline

Score on a scale. 21 items with an overall score ranging from 0 to 84. Higher scores indicates a negative outcome.

Epworth Sleepiness ScaleBaseline

Score on a scale with a total score of 0 to 24. Higher values means more severe problems.

Morbidity1 week

Diagnoses

Pharmacotherapy1 week

Type and dosage

Sleep Problem Acceptance Questionnaire1 week

Score on a scale. An 8-item self-report questionnaire, total scores range from 0 to 48 points. Higher values equals higher level of acceptance and a positive outcome.

Sick leave1 week

Percent

Montgomery Åsberg Depression Rating ScaleBaseline

Score on a scale. Higher score indicates more severe depression, a negative outcome. The overall score ranges from 0 to 60.

Trial Locations

Locations (1)

Uppsala University

🇸🇪

Uppsala, Sweden

Uppsala University
🇸🇪Uppsala, Sweden
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