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Idiopathic Hypersomnia

Idiopathic Hypersomnia - a Retrospective Characterization Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05150977
Acronym
IDAHO
Enrollment
69
Registered
2021-12-09
Start date
2021-12-01
Completion date
2023-12-31
Last updated
2024-02-28

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

Conditions

Hypersomnia, Idiopathic

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.

Interventions

OTHERPolysomnography

Reviewing collected data

Sponsors

Uppsala University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
PolysomnographyBaselineSpectral analyses
Multiple sleep latency testBaselineSleep latency and REM latency

Secondary

MeasureTime frameDescription
Morbidity1 weekDiagnoses
Sick leave1 weekPercent
Pharmacotherapy1 weekType and dosage
Epworth Sleepiness ScaleBaselineScore on a scale with a total score of 0 to 24. Higher values means more severe problems.
Sleep Problem Acceptance Questionnaire1 weekScore 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.
Insomnia Severity IndexBaselineScore on a scale. Seven items with a total score ranging from 0 to 28 points. Higher values means more severe insomnia, a negative outcome.
Montgomery Åsberg Depression Rating ScaleBaselineScore on a scale. Higher score indicates more severe depression, a negative outcome. The overall score ranges from 0 to 60.
Diurnal Type QuestionnaireBaselineScore on a scale. The overall score ranges 0 to 21, and higher scores equals more of a delayed sleep phase.
Munich Parasomnia ScreeningBaselineScore on a scale. 21 items with an overall score ranging from 0 to 84. Higher scores indicates a negative outcome.
The Ullanlinna Narcolepsy ScaleBaselineScore on a scale. 11 item with a total score ranging 0-44. Higher total score equals a negative outcome.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026