Idiopathic Hypersomnia (IDAHO)

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:

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.

Study Overview

• Status: Completed
• Conditions: Hypersomnia, Idiopathic
• Intervention / Treatment: Other: Polysomnography

• Study Type: Observational
• Enrollment (Actual): 69

Contacts and Locations

Study Locations

• Sweden
  • Uppsala, Sweden, 75185
    • Uppsala University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Idiopathic hypersomnia; Observation	Other: Polysomnography; Reviewing collected data; Other Names: Questionnaires; Multiple sleep latency test; Register data

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Polysomnography	Spectral analyses	Baseline
Multiple sleep latency test	Sleep latency and REM latency	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbidity	Diagnoses	1 week
Sick leave	Percent	1 week
Pharmacotherapy	Type and dosage	1 week
Epworth Sleepiness Scale	Score on a scale with a total score of 0 to 24. Higher values means more severe problems.	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.	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.	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.	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.	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.	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.	Baseline

Collaborators and Investigators

• Sponsor: Uppsala University
• Investigators: Study Chair: Rolf Karlsten, PhD, Uppsala University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: November 26, 2021
• First Submitted That Met QC Criteria: November 26, 2021
• First Posted (Actual): December 9, 2021

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disorders of Excessive Somnolence; Idiopathic Hypersomnia
• Other Study ID Numbers: 2021-03458

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No