Ignite Creation Date:
2024-05-06 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 2:19 PM
Study NCT ID:
NCT05150977
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2021-11-26
Brief Title:
Idiopathic Hypersomnia
Sponsor:
Uppsala University
Organization:
Uppsala University
Study Overview
Official Title:
Idiopathic Hypersomnia - a Retrospective Characterization Study
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IDAHO
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 pharmacotherapyQuestionnaires 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
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 pharmacotherapyQuestionnaires 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None