UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063308 |
|---|---|
| Receipt number | R000072466 |
| Scientific Title | Verification of equivalence between the home PSG device Nightgraf and polysomnography in patients with sleep-related breathing disorders |
| Date of disclosure of the study information | 2026/10/16 |
| Last modified on | 2026/10/16 11:00:55 |
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Basic information
Public title
A study comparing the home sleep test device Nightgraf with overnight in-hospital polysomnography in people with suspected sleep apnea
Acronym
Nightgraf vs PSG comparison study
Scientific Title
Verification of equivalence between the home PSG device Nightgraf and polysomnography in patients with sleep-related breathing disorders
Scientific Title:Acronym
Nightgraf-PSG simultaneous recording study
Region
| Japan |
Condition
Condition
Sleep-related breathing disorders (including suspected obstructive sleep apnea)
Classification by specialty
| Pneumology | Laboratory medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the equivalence of sleep stage scoring, arousal events and respiratory events between the home PSG device Nightgraf and polysomnography (PSG) recorded simultaneously in patients with sleep-related breathing disorders, and to develop a deep neural network-based automatic scoring program for sleep stages, arousals and respiratory events specific to Nightgraf.
Basic objectives2
Others
Basic objectives -Others
Agreement between a home EEG-based sleep device and standard polysomnography
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Agreement of Nightgraf sleep stage scoring with PSG as reference (epoch-by-epoch accuracy and Cohen's kappa for 30-second epochs), agreement of the arousal index, and agreement of Nightgraf respiratory indices (3% ODI and 2-3% desaturation with arousal) with PSG-derived AHI and RDI. Total sleep time, sleep latency, sleep efficiency, sleep stage proportions, ArI, AHI and ODI are assessed by intraclass correlation coefficients and Bland-Altman analysis, and severity classification by AHI and ODI is assessed by ROC analysis. For the automatic scoring program, agreement with visual scoring by clinical laboratory technologists is assessed.
Key secondary outcomes
Correlation between subjective sleep assessment (interview and questionnaires including PSQI and ESS) and the severity of sleep disorders such as sleep apnea-hypopnea assessed by PSG
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Aged 18 years or older at the time of consent 2) Suspected of having sleep-related breathing disorders, including obstructive sleep apnea, based on out-of-center sleep testing (OCST), pulse oximetry, interview, physical findings or clinical symptoms 3) Able to undergo simultaneous recording with PSG and Nightgraf 4) Provided written informed consent to participate in this study
Key exclusion criteria
1) Younger than 18 years 2) Difficulty wearing the Nightgraf electrodes or sensors due to skin disease, allergy, injury or other reasons 3) Judged ineligible by the principal investigator or sub-investigators for any other reason
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Yoshimine |
Organization
Shunkai Social Medical Corporation Inoue Hospital
Division name
Sleep Center
Zip code
850-0045
Address
6-12 Takara-machi, Nagasaki-shi, Nagasaki, Japan
TEL
095-844-1281
info@shunkaikai.jp
Public contact
Name of contact person
| 1st name | Shuji |
| Middle name | |
| Last name | Nakamura |
Organization
S'UIMIN Inc.
Division name
Business Division
Zip code
151-0061
Address
Hatsudai Center Building 817, 1-51-1 Hatsudai, Shibuya-ku, Tokyo, Japan
TEL
03-6276-3662
Homepage URL
biz-cro@suimin.co.jp
Sponsor or person
Institute
Shunkai Social Medical Corporation Inoue Hospital
Institute
Department
Personal name
Funding Source
Organization
S'UIMIN Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation Association Sapporo Yurinokai Hospital
Address
11-186 Yurigahara, Kita-ku, Sapporo, Hokkaido
Tel
011-771-1501
info@yurinokai.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is an observational study. Patients with suspected obstructive sleep apnea who are scheduled for diagnostic PSG at the Sleep Center of Inoue Hospital are invited, and those who provide written informed consent are enrolled. On the night of PSG, Nightgraf (forehead and chin electrodes, nasal cannula, abdominal sensor and SpO2 sensor) is attached together with the PSG sensors and both are recorded simultaneously overnight. Main observation items are patient characteristics, PSG and Nightgraf recording data, sleep questionnaires (PSQI, ESS and an S'UIMIN original questionnaire), periodic limb movement index, purpose of PSG, final clinical diagnosis and adverse events.
Management information
Registered date
| 2026 | Year | 10 | Month | 16 | Day |
Last modified on
| 2026 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072466
