UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028063 |
|---|---|
| Receipt number | R000032132 |
| Scientific Title | A study for evaluating the effect of sleep and fatigue using the air conditioner |
| Date of disclosure of the study information | 2017/07/04 |
| Last modified on | 2017/12/03 18:14:26 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study for evaluating the effect of sleep and fatigue using the air conditioner
Acronym
A study for evaluating the effect of sleep and fatigue using the air conditioner
Scientific Title
A study for evaluating the effect of sleep and fatigue using the air conditioner
Scientific Title:Acronym
A study for evaluating the effect of sleep and fatigue using the air conditioner
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare and evaluate the effect for sleep and fatigue using the air conditioner equipped with nanoeX or control device
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Uchida-Kraepelin test
Key secondary outcomes
Purdue Pegboard Test,
OSA sleep inventory MA version, Quality of life assessment,
Fatigue VAS,
Concentration VAS
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Use of air conditioner equipped with nanoeX for 3 consecutive days - washout period of 1 week - use of control device for 3 consecutive days
Interventions/Control_2
use of control device for 3 consecutive days - washout period of 1 week - use of air conditioner equipped with nanoeX for 3 consecutive days
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
| 40 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Male and female aged from 40 to 69
2) Pittsburgh sleep quality index global score is under 6
3) The total score of the Zc of OSA sleep inventory MA version is low
Key exclusion criteria
1) Subjects who routinely use test device
2) Subjects who perform an act for the improvement of the quality of the sleep, the stress, and fatigue
3) Subjects who routinely intake foods that possibly affect sleep, stress, and fatigue
4) Subjects who are unsuitable for the sleep in the group
5) Subjects who needs aromatherapy etc. at bedtime
6) Subjects who wake after sleep onset for nocturia more than twice a week
7) Subjects who drink more than once a week
8) Subjects who smoke
9) Night and day shift worker or manual laborer
10) Subjects who have a disease under treatment or are judged to that medical treatment are necessary by the doctor
11) Subjects who have under treatment or a history of sleep apnea syndrome or is strongly suspected of sleep apnea syndrome
12) Subjects who have had a diagnosis of chronic fatigue syndrome
13) Subjects who have under treatment or a history of serious disease (e.g., diabetes, liver disease, kidney disease, or heart disease) and disease to affect the adrenal cortical hormone secretion
14) Subjects who have any discomfort in the wrist or arm
15) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire and other questionnaires
16) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
17) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study
18) Subjects who intend to become pregnant or lactating
19) Subjects judged as unsuitable for the current study by the investigator
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirona Miura |
Organization
Higashi shinjyuku Clinic
Division name
Director
Zip code
Address
1-11-3 Okubo Shinjuku-ku Tokyo
TEL
03-6233-8581
koike@meiseikai-cl.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Nakagawa |
Organization
TTC Co.,Ltd.
Division name
Clinical Research Planning Department
Zip code
Address
Seibu Shinkin Bank Ebisu Bldg., 1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL
03-5459-5329
Homepage URL
t.nakagawa@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
Appliances company
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
Address
Tel
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
| 2017 | Year | 07 | Month | 04 | 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
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 04 | Day |
Last modified on
| 2017 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032132
