UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037789
Receipt number R000043096
Scientific Title Comparison between an automatic sleep-staging program via portable 1-channel electroencephalograph versus manual sleep staging by traditional polysomnography
Date of disclosure of the study information 2019/08/24
Last modified on 2023/02/25 10:15:30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Feasibility of an portable electroencephalograph

Acronym

Feasibility of an portable electroencephalograph

Scientific Title

Comparison between an automatic sleep-staging program via portable 1-channel electroencephalograph versus manual sleep staging by traditional polysomnography

Scientific Title:Acronym

Comparison between portable 1-channel electroencephalograph versus traditional polysomnography

Region

Japan


Condition

Condition

patients with sleep disorders and healthy humans

Classification by specialty

Pneumology Psychiatry Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

validation of a portable electroencephalograph (EEG) by comparing with polysomnography (PSG)

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

sleep staging based on the portable EEG and PSG

Key secondary outcomes

duration of each sleep stages


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

Outpatients who had undergone PSG examination at the Sleep Disorders Center of the Shiga University of Medical Science Hospital or healthy humans without any sleep or neuropsychiatric problems.

Key exclusion criteria

Participants had no competent to consent to contract.

Target sample size

45


Research contact person

Name of lead principal investigator

1st name Kenichi
Middle name
Last name Kuriyama

Organization

Shiga University of Medical Science

Division name

Department of Psychiatry

Zip code

520-2192

Address

Seta Tsukinowa-cho, Otsu

TEL

0775482291

Email

kenichik@belle.shiga-med.ac.jp


Public contact

Name of contact person

1st name Kenichi
Middle name
Last name Kuriyama

Organization

Shiga University of Medical Science

Division name

Department of Psychiatry

Zip code

520-2192

Address

Seta Tsukinowa-cho, Otsu

TEL

0775482291

Homepage URL


Email

kenichik@belle.shiga-med.ac.jp


Sponsor or person

Institute

Shiga University of Medical Science

Institute

Department

Personal name



Funding Source

Organization

AMED

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committee of Shiga University of Medical Science

Address

Seta Tsukinowa-cho, Otsu

Tel

0775483576

Email

hqrec@belle.shiga-med.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

滋賀医科大学附属病院


Other administrative information

Date of disclosure of the study information

2019 Year 08 Month 24 Day


Related information

URL releasing protocol

https://link.springer.com/article/10.1007/s41105-022-00421-5

Publication of results

Published


Result

URL related to results and publications

https://link.springer.com/article/10.1007/s41105-022-00421-5

Number of participants that the trial has enrolled

41

Results

Compared with polysomnography, Sleep Scope seemed to overestimate sleep latency by approximately 3 min, but there was no consistent tendency in bias in other sleep parameters. The kappa values ranged from 0.66 to 0.75 for experts' inter-rater polysomnography scores and from 0.62 to 0.67 for Sleep Scope versus polysomnography scores, which indicated sufficient agreement in the determination of sleep stages based on the Landis and Koch criteria.

Results date posted

2023 Year 02 Month 25 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

We recruited 26 adult outpatients aged < 80 years who had undergone PSG at the Sleep Disorders Center of the Shiga University of Medical Science Hospital and 15 healthy adult volunteers without any sleep or neuropsychiatric problems based on a clinical interview and a self-completed questionnaire score of <= 3 on the Athens Insomnia Scale between February 2018 and March 2018.

Participant flow

Participants with neuropsychiatric disorders such as dementia or epilepsy and those who engaged in any type of night-shift work (0:00-5:00) were excluded. Participants with sleep latency (SL) >= 180 min were also excluded to eliminate the effects of inadequate sleep hygiene or possible technical errors of SS and PSG measurements. For all participants, full-night sleep EEG was simultaneously measured using the SS and traditional PSG once during overnight hospitalization.

Adverse events

None

Outcome measures

Polysomnography records were manually scored by three sleep experts. Sleep Scope records were scored using a dedicated auto-staging algorithm. Sleep parameters, including total sleep time, sleep latency, wake after sleep onset, and sleep efficiency, were calculated. The epoch-by-epoch pairwise concordance based on the classification of sleep into five stages (i.e., wake, rapid eye movement, N1, N2, and N3) was also evaluated after validating homogeneity and bias between Sleep Scope and polysomnography.
The Mann-Whitney U test was used to examine differences in ratio of each sleep stage between patient and healthy groups, as well as the difference in the ratio of matches between PSG and Sleep Scope determinations for each expert between patient and healthy groups. Friedman test followed by Wilcoxon signed-rank test with Bonferroni correction was used to compare the means between Sleep Scope and the three PSG-expert measurements among sleep parameters (Total Sleep Time, Sleep Latency, Wake After Sleep Onset, and Sleep Efficiency). Bland-Altman plot analysis was used to evaluate bias between Sleep Scope and each PSG measurement on sleep parameters. For statistical assessment, each mean bias was tested with a one sample t test. Bland-Altman analysis was also separately performed for patient and healthy groups. To evaluate the pairwise concordance in sleep staging between Sleep Scope and PSG data, kappa value and percent agreement were calculated.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2018 Year 01 Month 18 Day

Date of IRB

2018 Year 02 Month 01 Day

Anticipated trial start date

2018 Year 02 Month 01 Day

Last follow-up date

2018 Year 08 Month 31 Day

Date of closure to data entry

2018 Year 09 Month 30 Day

Date trial data considered complete

2018 Year 12 Month 31 Day

Date analysis concluded

2019 Year 12 Month 31 Day


Other

Other related information

We recruited outpatients undergone PSG examination at the Sleep Disorders Center of the Shiga University of Medical Science Hospital. We also recruited healthy participants through an advertisement.


Management information

Registered date

2019 Year 08 Month 24 Day

Last modified on

2023 Year 02 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043096


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name