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

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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

patients with sleep disorders and healthy humans

Classification by specialty

Pneumology Psychiatry Adult

Classification by malignancy

Others

Genomic information

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

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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

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