Last reviewed · How we verify
NCT05150977: IDAHO
Idiopathic Hypersomnia
trial testing Polysomnography in Hypersomnia, Idiopathic in 69 participants. Completed in 31 December 2023.
30 June 2023
Quick facts
| Lead sponsor | Uppsala University |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 69 |
| Start date | 1 December 2021 |
| Primary completion | 30 June 2023 |
| Estimated completion | 31 December 2023 |
| Sites | 1 location across Sweden |
Drugs / interventions tested
- Polysomnography
Conditions studied
- Hypersomnia, Idiopathic — all drugs for Hypersomnia, Idiopathic →
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.
Verify or expand the search:
- PubMed search for NCT05150977
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05150977 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Uppsala University
- Last refreshed: 28 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05150977.
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