A Multi-Signal Based Monitoring System for CNS Hypersomnias

NCT05443373 | Unknown DMC

• 1 other identifier: 201902163A3
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 2

Brief Summary

This is a retrospective and prospective cohort study. There are 600 subjects (age 9-45) will be collected.The purposes of this study are as follows:(1) The main purpose is to use Multi-Signal Based Monitoring System to link with brain image data and perform cross-comparison to find out possible pathological mechanisms of these CNS hypersomnias.(2) Use the Multi-Signal Based Monitoring System to link with brain image data and perform cross-comparison to further screen out these clinically significant biomarkers for CNS hypersomnias, and to find ideal and accurate physiological biomarkers that can monitor the course of the disease.(3) Utilize these precisely monitored biomarkers to track changes in the biomarkers and the long-term course of these CNS hypersomnias, and evaluate the treatment effect and prognosis.(4) Use computer machine learning and other algorithms to analyze and construct a variety of faster and more accurate prediction models for these CNS hypersomnias, thereby achieving the goal of preventive medicine.

Conditions

Hypersomnia

Keywords

Sleep

Outcome Measures

Primary Outcomes (5)

• Polysomnography (PSG)

  Change in sleep latency (SL, mins) based on PSG during the study.

  Once a year until the study is completed (up to 3 years)

• Multiple sleep latency test (MSLT)

  Change in Change in sleep latency (SL, mins) based on MSLT during the study.

  Once a year until the study is completed (up to 3 years)

• HLA TYPING

  The investigators will use sequence-specific primer - polymerase chain reaction (SSP-PCR) to detect HLA-DQB1 and reverse sequence-specific oligonucleotide probes (SSOPs) to detect HLA-DQA1,and also use Sequencing Based Typing (SBT) and reverse sequence specific oligonucleotide (rSSO) to detect HLA-DRB and HLA-DQB in the lab.

  baseline

• Actigraphy

  Change in sleep latency (mins) based on actigraphy during the study.

  Once a year until the study is completed (up to 3 years)

• PET/MRI

  Positron Emission Tomography is a fusion of PET and MRI imaging techniques that can show the spread of diseased cells in soft tissue. The PET/MRI system can scan various parts of the patient and collect PET and MRI images separately for early diagnosis.

  through study completion, an average of 1 year

Secondary Outcomes (13)

• Conners' Continuous Performance Test (CPT)

  Once a year until the study is completed (up to 3 years)

• Wisconsin Card Sorting Test (WCST)

  Once a year until the study is completed (up to 3 years)

• Epworth Sleepoiness Scale (ESS)

  Once a year until the study is completed (up to 3 years)

• Pediatric Daytime Sleepiness Scale (PDSS)

  Once a year until the study is completed (up to 3 years)

• Short Form-36 (SF-36)

  Once a year until the study is completed (up to 3 years)

Study Arms (5)

experimental group (narcolepsy Type 1)

experimental group (narcolepsy Type 1, 300 subjects)

experimental group (narcolepsy Type 2)

experimental group (narcolepsy Type 2, 100 subjects)

experimental group (KLS)

experimental group (KLS, 100 subjects)

experimental group (IH)

experimental group (IH,50 subjects)

healthy control group

healthy control group (age and gender matched healthy subjects,50 subjects)

Eligibility Criteria

• Age: 9 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

9-45 years old subjects with narcolepsy , Kleine-Levin syndrome or Idiopathic Hypersomnia

You may qualify if:

• Patients with narcolepsy , Kleine-Levin syndrome(KLS) or Idiopathic Hypersomnia (IH) diagnosed by a physician who meet the ICSD-3 diagnostic criteria
• Age: 9-45 years old
• Those who agree to participate in this research and can sign the consent form.

You may not qualify if:

• Patients with epilepsy, head trauma and severe organic brain disease.
• Patients with severe Obstructive Sleep Apnea (OSA) and severe Periodic Limb Movement Disorder (PLMD) who have not received treatment.
• People with narcolepsy due to other physical and brain diseases.
• Those who cannot cooperate with the brain imaging examination and neurocognitive function test.
• Exclude those who have had brain surgery for brain tumor hemangioma, or those who have cerebral blood vessel metal clips.
• Exclude current pacemakers.
• Excluded those who had implanted artificial heart metal valve.
• Those who underwent surgery within the last 3 months were excluded.
• rule out claustrophobia
• Those who are unwilling to participate in this research or are unwilling to fill in the consent form.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (2)

Chang Gung Memorial Hospital, Linkou

Taoyuan, 333423, Taiwan

RECRUITING

Chang Gung Memorial Hospital

Taoyuan District, 333423, Taiwan

RECRUITING

Related Publications (17)

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  PMID: 843779 RESULT

• Anderson KN, Pilsworth S, Sharples LD, Smith IE, Shneerson JM. Idiopathic hypersomnia: a study of 77 cases. Sleep. 2007 Oct;30(10):1274-81. doi: 10.1093/sleep/30.10.1274.

  PMID: 17969461 RESULT

• Arnulf I, Rico TJ, Mignot E. Diagnosis, disease course, and management of patients with Kleine-Levin syndrome. Lancet Neurol. 2012 Oct;11(10):918-28. doi: 10.1016/S1474-4422(12)70187-4.

  PMID: 22995695 RESULT

• Ali M, Auger RR, Slocumb NL, Morgenthaler TI. Idiopathic hypersomnia: clinical features and response to treatment. J Clin Sleep Med. 2009 Dec 15;5(6):562-8.

  PMID: 20465024 RESULT

• Bassetti C, Aldrich MS. Idiopathic hypersomnia. A series of 42 patients. Brain. 1997 Aug;120 ( Pt 8):1423-35. doi: 10.1093/brain/120.8.1423.

  PMID: 9278632 RESULT

• Brankack J, Kukushka VI, Vyssotski AL, Draguhn A. EEG gamma frequency and sleep-wake scoring in mice: comparing two types of supervised classifiers. Brain Res. 2010 Mar 31;1322:59-71. doi: 10.1016/j.brainres.2010.01.069. Epub 2010 Feb 1.

  PMID: 20123089 RESULT

• CRITCHLEY M. Periodic hypersomnia and megaphagia in adolescent males. Brain. 1962 Dec;85:627-56. doi: 10.1093/brain/85.4.627. No abstract available.

  PMID: 14023898 RESULT

• Engstrom M, Hallbook T, Szakacs A, Karlsson T, Landtblom AM. Functional magnetic resonance imaging in narcolepsy and the kleine-levin syndrome. Front Neurol. 2014 Jun 25;5:105. doi: 10.3389/fneur.2014.00105. eCollection 2014.

  PMID: 25009530 RESULT

• Fraiwan L, Lweesy K, Khasawneh N, Wenz H, Dickhaus H. Automated sleep stage identification system based on time-frequency analysis of a single EEG channel and random forest classifier. Comput Methods Programs Biomed. 2012 Oct;108(1):10-9. doi: 10.1016/j.cmpb.2011.11.005. Epub 2011 Dec 16.

  PMID: 22178068 RESULT

• Frenette E, Kushida CA. Primary hypersomnias of central origin. Semin Neurol. 2009 Sep;29(4):354-67. doi: 10.1055/s-0029-1237114. Epub 2009 Sep 9.

  PMID: 19742411 RESULT

• Grimaldi D, Pierangeli G, Barletta G, Terlizzi R, Plazzi G, Cevoli S, Franceschini C, Montagna P, Cortelli P. Spectral analysis of heart rate variability reveals an enhanced sympathetic activity in narcolepsy with cataplexy. Clin Neurophysiol. 2010 Jul;121(7):1142-7. doi: 10.1016/j.clinph.2010.01.028. Epub 2010 Feb 23.

  PMID: 20181520 RESULT

• Grosse-Wentrup M, Liefhold C, Gramann K, Buss M. Beamforming in noninvasive brain-computer interfaces. IEEE Trans Biomed Eng. 2009 Apr;56(4):1209-19. doi: 10.1109/TBME.2008.2009768.

  PMID: 19423426 RESULT

• Guilleminault C, Lopes MC, Hagen CC, da Rosa A. The cyclic alternating pattern demonstrates increased sleep instability and correlates with fatigue and sleepiness in adults with upper airway resistance syndrome. Sleep. 2007 May;30(5):641-7. doi: 10.1093/sleep/30.5.641.

  PMID: 17552380 RESULT

• Hadjiyannakis K, Ogilvie RD, Alloway CE, Shapiro C. FFT analysis of EEG during stage 2-to-REM transitions in narcoleptic patients and normal sleepers. Electroencephalogr Clin Neurophysiol. 1997 Nov;103(5):543-53. doi: 10.1016/s0013-4694(97)00064-3.

  PMID: 9402885 RESULT

• Jaussent I, Morin CM, Ivers H, Dauvilliers Y. Incidence, worsening and risk factors of daytime sleepiness in a population-based 5-year longitudinal study. Sci Rep. 2017 May 2;7(1):1372. doi: 10.1038/s41598-017-01547-0.

  PMID: 28465612 RESULT

• Kanbayashi T, Kodama T, Kondo H, Satoh S, Inoue Y, Chiba S, Shimizu T, Nishino S. CSF histamine contents in narcolepsy, idiopathic hypersomnia and obstructive sleep apnea syndrome. Sleep. 2009 Feb;32(2):181-7. doi: 10.1093/sleep/32.2.181.

  PMID: 19238805 RESULT

• Pike M, Stores G. Kleine-Levin syndrome: a cause of diagnostic confusion. Arch Dis Child. 1994 Oct;71(4):355-7. doi: 10.1136/adc.71.4.355.

  PMID: 7979534 RESULT

MeSH Terms

Conditions

Disorders of Excessive Somnolence

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Yu-Shu Huang, PhD

  Principal Investigator

  STUDY DIRECTOR

Central Study Contacts

Yu-Shu Huang, PhD

CONTACT

+886 3 3281200; yushuhuang1212@gmail.com

Study Design

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

Study Record Dates

• First Submitted: May 30, 2022
• First Posted: July 5, 2022
• Study Start: June 4, 2020
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: July 5, 2022

Record last verified: 2022-05

Locations

TW (2)