UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037618 |
|---|---|
| Receipt number | R000042861 |
| Scientific Title | Validation study of sleep score measured by Fitbit (Fitbit, Inc.) |
| Date of disclosure of the study information | 2019/08/08 |
| Last modified on | 2023/09/21 18:26:31 |
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Basic information
Public title
Validation study of sleep score measured by Fitbit (Fitbit, Inc.)
Acronym
Validation study of sleep score measured by Fitbit (Fitbit, Inc.)
Scientific Title
Validation study of sleep score measured by Fitbit (Fitbit, Inc.)
Scientific Title:Acronym
Validation study of sleep score measured by Fitbit (Fitbit, Inc.)
Region
| Japan |
Condition
Condition
Those who are scheduled to undergo the Polysomnography (PSG)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the sleep score measured by Fitbit charge 3 in Japanese adults with the Polysomnography (PSG) to examine the validity of Fibit's sleep score.
Basic objectives2
Others
Basic objectives -Others
Validation study for measurement scale
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Sleep score measured by Polysomnography (PSG)
total sleep time
wake after sleep onset
Rapid Eye Movement(REM) sleep
Non REM sleep N1+N2
Non REM sleep N3
Sleep latency
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Those who are scheduled to undergo Polysomnography (PSG)
2. Suspected breathing disorder such as nighttime snoring or apnea, or those complaining of daytime hypersomnia symptoms
3. Written informed consent for participation in this examination is obtained
Key exclusion criteria
1. Those with nighttime insomnia
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Inoue |
Organization
Yoyogi Sleep Disorder Center
Institute of Neuropsychiatry
Division name
President / Research associate
Zip code
151-0053
Address
5-10-10 SY buildings, Yoyogi, Shibuya-ku, Tokyo
TEL
03-6300-5401
inoue@somnology.com
Public contact
Name of contact person
| 1st name | Mina |
| Middle name | |
| Last name | Kobayashi |
Organization
Yoyogi Sleep Disorder Center / Institute of Neuropsychiatry
Division name
Research Department / Research associate
Zip code
151-0053
Address
5-10-10 SY buildings, Yoyogi, Shibuya-ku, Tokyo
TEL
03-6300-5401
Homepage URL
kobayashi@somnology.com
Sponsor or person
Institute
Institute of Neuropsychiatry
Institute
Department
Personal name
Funding Source
Organization
Foundation for Biomedical Research and Innovation at Kobe
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Translational Research Center for Medical Innovation (TRI)
Foundation for Biomedical Research and Innovation at Kobe
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institute of Neuropsychiatry Ethics Board
Address
91 Bentencho, Shinjyuku-ku, Tokyo
Tel
03-3260-9171
jimukyoku@ionp.or.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
医療法人社団絹和会 睡眠総合ケアクリニック代々木（東京）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | Month | 08 | Day |
Related information
URL releasing protocol
unpublished
Publication of results
Unpublished
Result
URL related to results and publications
unpublished
Number of participants that the trial has enrolled
60
Results
There was well concordance between sleep scores measured with the Fitbit charge 3 and those measured with the conventional polysomnography (PSG) for sleep duration. In addition, there were weak concordance for WASO, REM sleep duration, and shallow+deep sleep duration (Stage N1+N2+N3).
Results date posted
| 2023 | Year | 09 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Age (mean[SD]) : 35.9 [13.8]
Age group: 20-29 y; 50.9%, 30-39 y; 16.4%, 40-49 y: 7.3%, 50-59 y; 20.0%, 60- y; 5.5%
Sex (male): 58.2%
Type of sleep disorder: Sleep apnea syndrome; 36.4%, Non-pathological sleep disorder; 29.1%, Others; 34.5%
Participant flow
Sixty subjects were enrolled and received polysomnography (PSG). Of 60 subjects, 5 were excluded from the validity analysis because of the lack of data measured by the Fitbit device.
Adverse events
Not applicable
Outcome measures
ICC (intraclass correlation coefficients) [Lower 95% confidence interval]
Total sleep time; 0.714 [0.555]
Wake after sleep onset (WASO); 0.342 [0.0959]
Rapid Eye Movement(REM) sleep; 0.535 [0.301]
Non REM sleep N1+N2; 0.115 [-0.141]
Non REM sleep N3; 0.215 [-0.036]
Stage N1+N2+N3; 0.488 [0.239]
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 02 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 04 | Month | 10 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2019 | Year | 08 | Month | 07 | Day |
Last modified on
| 2023 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042861
