Uppsala University
Uppsala, 75185, Sweden
NCT Number: NCT05150977
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.
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Notify Me18 year–70 year
All sexes
Observational
Uppsala, 75185, Sweden
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Reviewing collected data
Other names: Multiple sleep latency test, Questionnaires, Register data
Time frame: Baseline
Spectral analyses
Time frame: Baseline
Sleep latency and REM latency
Time frame: 1 week
Diagnoses
Time frame: 1 week
Percent
Time frame: 1 week
Type and dosage
Time frame: Baseline
Score on a scale with a total score of 0 to 24. Higher values means more severe problems.
Time frame: 1 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.
Time frame: Baseline
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.
Time frame: Baseline
Score on a scale. Higher score indicates more severe depression, a negative outcome. The overall score ranges from 0 to 60.
Time frame: Baseline
Score on a scale. The overall score ranges 0 to 21, and higher scores equals more of a delayed sleep phase.
Time frame: Baseline
Score on a scale. 21 items with an overall score ranging from 0 to 84. Higher scores indicates a negative outcome.
Time frame: Baseline
Score on a scale. 11 item with a total score ranging 0-44. Higher total score equals a negative outcome.
Uppsala University
Other
Idiopathic Hypersomnia - a Retrospective Characterization Study
Acronym: IDAHO
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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