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NCT05150977: IDAHO

Idiopathic Hypersomnia

Completed Last updated 28 February 2024
What this trial tests

trial testing Polysomnography in Hypersomnia, Idiopathic in 69 participants. Completed in 31 December 2023.

Timeline
1 December 2021
Primary endpoint
30 June 2023
31 December 2023

Quick facts

Lead sponsorUppsala University
StatusCompleted
Study typeOBSERVATIONAL
Enrollment69
Start date1 December 2021
Primary completion30 June 2023
Estimated completion31 December 2023
Sites1 location across Sweden

Drugs / interventions tested

Conditions studied

Sponsor

Uppsala University

Who can join

Adults 18 to 70, any sex, with Hypersomnia, Idiopathic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other trials of Polysomnography

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