UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056163 |
|---|---|
| Receipt number | R000064173 |
| Scientific Title | Research for Indoor Environmental Conditions of Noise and Sleep Quality for Healthy Aging in Place |
| Date of disclosure of the study information | 2024/11/15 |
| Last modified on | 2024/11/15 10:43:39 |
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Basic information
Public title
Research for Indoor Environmental Conditions of Noise and Sleep Quality for Healthy Aging in Place
Acronym
Research for Indoor Environmental Conditions of Noise and Sleep Quality
Scientific Title
Research for Indoor Environmental Conditions of Noise and Sleep Quality for Healthy Aging in Place
Scientific Title:Acronym
Research for Indoor Environmental Conditions of Noise and Sleep Quality
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This research project will conduct a sleep experiment on healthy research participants through an experiment on the presentation of noise stimuli under a nocturnal sleep environment. In addition to comparisons within the research participants (during normal sleep and in the experimental environment), comparisons among research participants (e.g., differences in sleep habits, differences in individual characteristics such as noise sensitivity, etc.) will be conducted to elucidate the effects of noise and to explore factors that improve wellbeing.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effects of noise presentation during sleep on sleep efficiency and sleep state
Key secondary outcomes
Data of auditory thresholds
Sleep evaluation data excluding sleep efficiency
Sleep habit data from wearable devices
Measurement data (number of steps, activity, heart rate, calories burned) by wearable device
Sleep evaluation data by sleep condition
Experimental environment data (sound)
Experimental environment data (temperature and humidity)
Stimulus presentation data upon waking up
Questionnaire response data (age, gender, living environment, noise sensitivity, personality, insomnia)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Noise is presented at time intervals when the research participants are sleeping.
Sound, light, and wind stimuli are presented to the research participants when they wake up.
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
I. Persons who are able to obtain free and voluntary written consent to participate in the research from the person concerned.
II. Over 60 years of age
III. Persons who are able to cooperate in the sleep experiment
IV. Those who can participate in all experimental conditions (consecutive days of the week)
V. Those who are not in the habit of using information and communication terminals (PCs, smartphones, tablets) until just before bedtime on a daily basis.
Key exclusion criteria
I. Patients with sleep disorders (e.g., sleep apnea syndrome, nocturia)
II. Health disorders that can impact sleep (e.g., chronic pain)
III. Complete hearing loses
IV. Primary psychiatric disorders aside from anxiety disorders (e.g., schizophrenia)
V. Those who have a smoking habit and/or excessive drinking habit
VI. Recent trans-meridian travel (participants will be required to wait 3 days for each jet lag hour before entering the study);
VII. Shift-work involving overnight shifts on more than 3 occasions within the last 60-days prior to entry into the study
VIII. Change in use of medication that affect sleep, circadian rhythms, or alertness in the last month (e.g., hypnotics, benzodiazepines, neuroleptics, melatonin)
IX. Persons suffering from depression
X. participants not stabilized (less than 2 months) on lithium or melatoninergic agents
XI. Participant have difficulty participating consecutively
XII. Participant do not have the habit of wearing nightclothes to bed
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Chikai |
Organization
National Institute of Advanced Industrial Science and Technology (AIST)
Division name
Human Informatics and Interaction Research Institute
Zip code
305-8566
Address
Higashi 1-1-1, Tsukuba, Ibaraki
TEL
050-3521-2559
M-NRC-experiment-ml@aist.go.jp
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Chikai |
Organization
National Institute of Advanced Industrial Science and Technology (AIST)
Division name
Human Informatics and Interaction Research Institute
Zip code
305-8566
Address
Higashi 1-1-1, Tsukuba, Ibaraki
TEL
050-3521-2559
Homepage URL
M-NRC-experiment-ml@aist.go.jp
Sponsor or person
Institute
National Institute of Advanced Industrial Science and Technology (AIST)
Institute
Department
Personal name
Funding Source
Organization
National Research Councli Canada (NRC)
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Canada
Other related organizations
Co-sponsor
National Research Councli Canada (NRC)
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institute of Advanced Industrial Science and Technology Research Ethics Board
Address
Higashi 1-1-1, Tsukuba, Ibaraki
Tel
029-861-2120
safe-life-ml@aist.go.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2024-128
Org. issuing International ID_1
National Research Council Research Ethics Board
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 | 11 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 02 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 11 | Month | 15 | Day |
Last modified on
| 2024 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064173
