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Completed

NCT Number: NCT05150977

Idiopathic Hypersomnia

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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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Uppsala University

Uppsala, 75185, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Idiopathic hypersomnia, according to the The International Classification of Sleep Disorders - Third Edition (ICSD-3)

Exclusion criteria

  • Other serious somatic or psychiatric disease
  • Drug additction with drug seeking behaviour

Treatment and study plan

Polysomnography

Other

Reviewing collected data

Other names: Multiple sleep latency test, Questionnaires, Register data

Primary outcomes

  1. Polysomnography

    Time frame: Baseline

    Spectral analyses

  2. Multiple sleep latency test

    Time frame: Baseline

    Sleep latency and REM latency

Secondary outcomes

  1. Morbidity

    Time frame: 1 week

    Diagnoses

  2. Sick leave

    Time frame: 1 week

    Percent

  3. Pharmacotherapy

    Time frame: 1 week

    Type and dosage

  4. Epworth Sleepiness Scale

    Time frame: Baseline

    Score on a scale with a total score of 0 to 24. Higher values means more severe problems.

  5. Sleep Problem Acceptance Questionnaire

    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.

  6. Insomnia Severity Index

    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.

  7. Montgomery Åsberg Depression Rating Scale

    Time frame: Baseline

    Score on a scale. Higher score indicates more severe depression, a negative outcome. The overall score ranges from 0 to 60.

  8. Diurnal Type Questionnaire

    Time frame: Baseline

    Score on a scale. The overall score ranges 0 to 21, and higher scores equals more of a delayed sleep phase.

  9. Munich Parasomnia Screening

    Time frame: Baseline

    Score on a scale. 21 items with an overall score ranging from 0 to 84. Higher scores indicates a negative outcome.

  10. The Ullanlinna Narcolepsy Scale

    Time frame: Baseline

    Score on a scale. 11 item with a total score ranging 0-44. Higher total score equals a negative outcome.

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Registry information

Official study title

Idiopathic Hypersomnia - a Retrospective Characterization Study

Acronym: IDAHO

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 9, 2021
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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