Idiopathic Hypersomnia

NCT05150977 | Completed

• 1 other identifier: 2021-03458
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 1

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. 1.Are there subgroups within the IH-group, that can be retrospectively characterized out of data from polysomnography, PSG and MSLT.
2. 2.What are the relationships between IH, and possible IH subgroups, and morbidity, mortality, and sick leave, using retrospective register data?
3. 3.What is the natural course of IH, and possible IH subgroups, assessed with questionnaires that measures daytime sleepiness, depression, and insomnia?
4. 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.

Conditions

Hypersomnia, Idiopathic

Outcome Measures

Primary Outcomes (2)

• Polysomnography

  Spectral analyses

  Baseline

• Multiple sleep latency test

  Sleep latency and REM latency

  Baseline

Secondary Outcomes (10)

• Morbidity

  1 week

• Sick leave

  1 week

• Pharmacotherapy

  1 week

• Epworth Sleepiness Scale

  Baseline

• Sleep Problem Acceptance Questionnaire

  1 week

Study Arms (1)

Idiopathic hypersomnia

Observation

Other: Polysomnography

Interventions

Polysomnography OTHER

Reviewing collected data

Also known as: Multiple sleep latency test, Questionnaires, Register data

Idiopathic hypersomnia

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

Uppsala University

Uppsala, 75185, Sweden

Location

MeSH Terms

Conditions

Idiopathic Hypersomnia

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Disorders of Excessive Somnolence; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Rolf Karlsten, PhD

  Uppsala University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2021
• First Posted: December 9, 2021
• Study Start: December 1, 2021
• Primary Completion: June 30, 2023
• Study Completion: December 31, 2023
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

SE (1)