Hypersomnia, IdiopathicIDAHONCT05150977
Idiopathic Hypersomnia
An observational study of Hypersomnia, Idiopathic, run by Uppsala University at 1 site in Sweden.
Trial summary
Idiopathic hypersomnia (IH) is characterized by non-restoring night-time sleep, excessive daytime sleepiness, sleep inertia, impaired cognitive functioning and autonomic symptoms. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypersomnia, Idiopathic
- What is being tested?
- Polysomnography
- How many people
- 69 participants
- Where
- 1 siteSweden
- Study dates
- 1 Dec 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible subjects are 185 individuals with idiopathic hypersomnia (IH) assessed and diagnosed using polysomnography and multiple sleep latency test at the Sleep unit, Uppsala university hospital between 2010-01-01 and 2019-12-31. Inclusion criteria is IH, according to the ICSD-3.
Who may be able to join
- Idiopathic hypersomnia, according to the The International Classification of Sleep Disorders - Third Edition (ICSD-3)
Who cannot join
- Other serious somatic or psychiatric disease
- Drug additction with drug seeking behaviour
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Idiopathic Hypersomnia - a Retrospective Characterization Study
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:
- Are there subgroups within the IH-group, that can be retrospectively characterized out of data from polysomnography, PSG and MSLT.
- What are the relationships between IH, and possible IH subgroups, and morbidity, mortality, and sick leave, using retrospective register data?
- What is the natural course of IH, and possible IH subgroups, assessed with questionnaires that measures daytime sleepiness, depression, and insomnia?
- 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.
- Conditions
- Hypersomnia, Idiopathic
- Being tested
- Polysomnography
- Medical subject headings
- Idiopathic Hypersomnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolysomnographyOther
Also called Multiple sleep latency test, Questionnaires, Register data
Reviewing collected data
| Study group | Role | What they receive |
|---|---|---|
| Idiopathic hypersomnia | Observation Receives: Other: Polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polysomnography
Spectral analyses
Measured: Baseline
Multiple sleep latency test
Sleep latency and REM latency
Measured: Baseline
Secondary outcomes (10)
Morbidity
Diagnoses
Measured: 1 week
Sick leave
Percent
Measured: 1 week
Pharmacotherapy
Type and dosage
Measured: 1 week
Epworth Sleepiness Scale
Score on a scale with a total score of 0 to 24. Higher values means more severe problems.
Measured: Baseline
Sleep Problem Acceptance Questionnaire
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.
Measured: 1 week
Insomnia Severity Index
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.
Measured: Baseline
Montgomery Åsberg Depression Rating Scale
Score on a scale. Higher score indicates more severe depression, a negative outcome. The overall score ranges from 0 to 60.
Measured: Baseline
Diurnal Type Questionnaire
Score on a scale. The overall score ranges 0 to 21, and higher scores equals more of a delayed sleep phase.
Measured: Baseline
Munich Parasomnia Screening
Score on a scale. 21 items with an overall score ranging from 0 to 84. Higher scores indicates a negative outcome.
Measured: Baseline
The Ullanlinna Narcolepsy Scale
Score on a scale. 11 item with a total score ranging 0-44. Higher total score equals a negative outcome.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start1 Dec 2021
- Primary completion30 Jun 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypersomnia, IdiopathicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rolf Karlsten, PhD, Study chair, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05150977
- Sponsor's protocol ID
- 2021-03458
- Acronym
- IDAHO
- Status last verified
- Feb 2024
- First submitted
- 26 Nov 2021
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Idiopathic Hypersomnia - a Retrospective Characterization Study
- ClinicalTrials.gov ID
- NCT05150977
- Acronym / sponsor ID
- IDAHO / 2021-03458
- Conditions
- Hypersomnia, Idiopathic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 9 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Are there subgroups within the IH-group, that can be retrospectively characterized out of data from polysomnography, PSG and MSLT.
- What are the relationships between IH, and possible IH subgroups, and morbidity, mortality, and sick leave, using retrospective register data?
- What is the natural course of IH, and possible IH subgroups, assessed with questionnaires that measures daytime sleepiness, depression, and insomnia?
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Idiopathic hypersomnia | – | Other: PolysomnographyObservation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible subjects are 185 individuals with idiopathic hypersomnia (IH) assessed and diagnosed using polysomnography and multiple sleep latency test at the Sleep unit, Uppsala university hospital between 2010-01-01 and 2019-12-31. Inclusion criteria is IH, according to the ICSD-3.
Key inclusion criteria (1 listed)
- Idiopathic hypersomnia, according to the The International Classification of Sleep Disorders - Third Edition (ICSD-3)
Key exclusion criteria (2 listed)
- Other serious somatic or psychiatric disease
- Drug additction with drug seeking behaviour
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PolysomnographyAlso: Multiple sleep latency test, Questionnaires, Register dataReviewing collected data | Other | Idiopathic hypersomnia |
Primary outcome
Polysomnography
Time frame: Baseline
Spectral analyses
Multiple sleep latency test
Time frame: Baseline
Sleep latency and REM latency
10 secondary outcomes
Morbidity
Time frame: 1 week
Sick leave
Time frame: 1 week
Pharmacotherapy
Time frame: 1 week
Epworth Sleepiness Scale
Time frame: Baseline
Sleep Problem Acceptance Questionnaire
Time frame: 1 week
Insomnia Severity Index
Time frame: Baseline
Montgomery Åsberg Depression Rating Scale
Time frame: Baseline
Diurnal Type Questionnaire
Time frame: Baseline
Munich Parasomnia Screening
Time frame: Baseline
The Ullanlinna Narcolepsy Scale
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rolf Karlsten, PhD study chair
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypersomnia, Idiopathic, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Polysomnography (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.