UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054885 |
|---|---|
| Receipt number | R000058182 |
| Scientific Title | A comparison of sleep apnea parameters between two different combinations of polysomnography equipment and analysis center |
| Date of disclosure of the study information | 2024/07/18 |
| Last modified on | 2024/07/23 15:14:45 |
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Basic information
Public title
A comparison of sleep apnea parameters between two different combinations of polysomnography equipment and analysis center
Acronym
Uniformity of PSG analyses
Scientific Title
A comparison of sleep apnea parameters between two different combinations of polysomnography equipment and analysis center
Scientific Title:Acronym
Uniformity of PSG analyses
Region
| Japan |
Condition
Condition
sleep apnea syndrome
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Polysomnography (PSG) is known as the gold standard to make a diagnosis and severity of sleep apnea syndrome. The national health assurance permits to use nasal positive airway therapy when apnea hypopnea index (AHI) is equal to or higher than 20 times/h using PSG or 40 times/h using simplified PSG in Japan. Analysis of PSG is usually performed by a polysomnographer authorized by Japanese Society of Sleep Research. However, scoring variability between polysomnography technologists in different sleep laboratories has been reported, and recently new equipment for PSG study are also developed. Although reproducibility of scorings by different polysomnographers has been confirmed in a few scoring companies, inter-variabilities among different companies or different equipment are yet to be done. Therefore, the major outcome is uniformity of AHIs obtained by different equipment and different scoring companies.
Basic objectives2
Others
Basic objectives -Others
When AHIs obtained by different equipment and different scoring companies are significantly differ, some parameters obtained by PSG are set as description variables.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
They include body mass index (BMI), apnea index (AI), total sleep time (TST) WASO arousal index (arousals), sleep latency (SL), total recording time (TRT), percentage of stage 3 sleep (N3), supine time (Tsup), not-supine time (Tnsup), AHI at supine posture (AHIsup), AHI at not-supine time (AHInsup), and 3% oxygen desaturation index (ODI3).
Key secondary outcomes
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Tho patients, who were suspected to be suffering from sleep apnea syndrome, and were examined with PSGs Alice or NoxA1 system.
Key exclusion criteria
The patients who refused to be a participant.
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | Tetsuri |
| Middle name | |
| Last name | Kondo |
Organization
Shonan Fujisawa Tokushukai Hospital
Division name
Department of Respiratory Medicine
Zip code
251-0041
Address
1-5-1 Kandai Tsujido, Fujisawa, Kanagawa
TEL
+81466351177
tetsuri@ctmc.jp
Public contact
Name of contact person
| 1st name | Tetsuri |
| Middle name | |
| Last name | Kondo |
Organization
Shonan Fujisawa Tokushukai Hospital
Division name
Department of Respiratory Medicine
Zip code
251-0041
Address
1-5-1 Kandai Tsujido, Fujisawa, Kanagawa
TEL
0466351177
Homepage URL
tetsuri@ctmc.jp
Sponsor or person
Institute
Shonan Fujisawa Tokushukai Hospital
Institute
Department
Personal name
Tetsuri Kondo
Funding Source
Organization
not required
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Tokushukai Group Ethics Committee
Address
Tokyodo Chiyoda Bldg. 15F, 1-3-1, Kudan-minami, Chiyoda-ku, Tokyo 102-0074, Japan
Tel
03-3263-4801
mirai-ec1@mirai-iryo.com
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
| 2024 | Year | 07 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
528
Results
The difference in AHI between Group A (Alice+Phillips) and Group N (Nox+Teijin) was significant. In multiple correlation analysis, the prediction equation was established for two indices in both groups, ODI and arousal response (AIx), with a greater contribution from AIx in group A and from ODI in group N. ODIs are objective changes, but AIx is largely dependent on the analyst's subjectivity, so it is assumed that the evaluation of AIx influenced the difference in AHI.
Results date posted
| 2024 | Year | 07 | Month | 05 | Day |
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The 47th Annual meeting of Japanese Society of Sleep Research
The 48th Annual meeting of Japanese Society of Sleep Research
Management information
Registered date
| 2024 | Year | 07 | Month | 05 | Day |
Last modified on
| 2024 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058182
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