UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061827 |
|---|---|
| Receipt number | R000070704 |
| Scientific Title | Health Impact Investigation of Ionless (Hypochlorous Acid Water) Space Spraying |
| Date of disclosure of the study information | 2026/06/08 |
| Last modified on | 2026/06/08 16:11:24 |
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Basic information
Public title
Health Impact Investigation of Ionless (Hypochlorous Acid Water) Space Spraying
Acronym
Health Impact Investigation of Ionless (Hypochlorous Acid Water) Space Spraying
Scientific Title
Health Impact Investigation of Ionless (Hypochlorous Acid Water) Space Spraying
Scientific Title:Acronym
Health Impact Investigation of Ionless (Hypochlorous Acid Water) Space Spraying
Region
| Japan |
Condition
Condition
Adverse events (eye itching, eye redness, sore throat, runny nose, cough, odor of hypochlorous acid solution, stress caused by the sound of the nebulizer)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate whether the use of Ionless (hypochlorous acid water) for space spraying in hospital rooms has any health effects on inpatients.
As background, there have been numerous cases of inpatients contracting COVID-19 within the hospital in addition to their original treatment, resulting in prolonged hospital stays or death due to poor prognosis. Aerosol transmission, one of the primary routes of transmission for COVID-19, occurs when a person inhales viruses suspended in the air. Therefore, as a measure to prevent infection, it is necessary to reduce the concentration of viruses within a given space. To remove the viruses themselves, hypochlorous acid water-based humidifiers and hypochlorous acid water for use in humidifiers are commercially available from multiple manufacturers and are widely used in medical institutions.
In contrast, according to the results of a survey on health hazards conducted by the Japan Poison Information Center, while there have been reports of accidents involving products that claim to disinfect the air using chlorine dioxide (formed by the oxidation of chlorite), there have been no reports of health hazards resulting from the aerial spraying of hypochlorous acid water. However, since hypochlorous acid water is classified as a general merchandise item under the Pharmaceutical and Medical Devices Act, there is a lack of data on the efficacy and safety of its aerial spraying. Therefore, we will conduct a pilot study that could provide preliminary data on its safety in the presence of people.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The observation items on the health observation sheet include itchy eyes, red eyes, sore throat, runny nose, cough, the odor of hypochlorous acid water, and stress caused by the sound of the nebulizer. Staff at the collaborating research institutions will determine the presence or absence of each symptom based on interviews with patients. Prior to the study, the principal investigator will brief the staff on the details of the observation items and confirm that patients are free of all symptoms listed before space spraying begins.
The primary endpoint is to calculate the incidence rate of adverse events from the health observation sheet and to assess safety based on that rate.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Hypochlorous Acid Water Spray Group: Set the spray program settings on the CL Mist L humidifier manufactured by Nipro Corporation so that the effective chlorine concentration in the air reaches 0.02 ppm during the spray period. Based on experiments conducted in patient rooms at the Uchimaru Medical Center, three units each of humidifiers and circulators will be used in four-bed rooms, one unit each in single rooms, and two units each in two-bed rooms. Additionally, the ventilation system in all patient rooms will be set to the low setting. Since the ambient chlorine concentration and indoor humidity are proportional during atomization, the measured indoor humidity value at an effective chlorine concentration of 0.02 ppm is set and verified through daily humidity measurements on the indoor environment check sheet. The humidification time is set for 12 hours, from 8:00 AM to 8:00 PM. This will be conducted for 30 days. Co-investigator Mikio Takahashi will measure and verify the effective chlorine concentration once a week starting from the first day of atomization.
Interventions/Control_2
Tap Water Spray Group (Placebo) Since the effective chlorine concentration in tap water is below the detection limit, the humidity conditions will be set to match those of the hypochlorous acid water group at an effective chlorine concentration of 0.02 ppm. The humidification period is set for 12 hours, from 8:00 a.m. to 8:00 p.m. The experiment will be conducted for 30 days. The spraying conditions are the same as those for the hypochlorous acid spray group.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The study population consists of patients hospitalized at Uguisu-juku Onsen Hospital during the enrollment period who are capable of communicating, understand the study protocol, and have expressed a willingness to participate (proxy signing of the informed consent form is permitted). Patients must not exhibit any of the following symptoms: itchy eyes, red eyes, sore throat, runny nose, or cough.
Key exclusion criteria
Patients whom the principal investigator has determined to be unsuitable as study participants.
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | SHIMOOKI |
Organization
Iwate Medical University
Division name
Department of General Practice
Zip code
020-0021
Address
1-2-1 Chuo-dori, Morioka City, Iwate Prefecture
TEL
019-613-6111
osashimo@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Mikio |
| Middle name | |
| Last name | TAKAHASHI |
Organization
Iwate Medical University
Division name
Department of General Practice
Zip code
020-0021
Address
1-2-1 Chuo-dori, Morioka City, Iwate Prefecture
TEL
019-613-6111
Homepage URL
mitakaha@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Iwate Medical University
Address
1-2-1 Chuo-dori, Morioka City, Iwate Prefecture
Tel
019-613-6111
mitakaha@iwate-med.ac.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 | 06 | Month | 08 | Day |
Related information
URL releasing protocol
https://iwate-med.bvits.com/rinri/Apply/show.aspx?TYPE=4&ID=2745
Publication of results
Published
Result
URL related to results and publications
https://iwate-med.bvits.com/rinri/Apply/show.aspx?TYPE=4&ID=2745
Number of participants that the trial has enrolled
32
Results
There were no adverse events in either the ion-free hypochlorous acid water group or the tap water group, and the 95percent confidence intervals were 0from13.0 percent for the ion-free hypochlorous acid water group and 0from22.0percent for the tap water group.
Results date posted
| 2026 | Year | 06 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The study population consists of patients hospitalized at Uguisu-juku Onsen Hospital during the enrollment period who are capable of communicating, understand the study protocol, and have expressed a willingness to participate (proxy signing of the informed consent form is permitted). Patients must not exhibit any of the following symptoms: itchy eyes, red eyes, sore throat, runny nose, or cough.
Participant flow
Staff at the collaborating research institutions will determine the presence or absence of symptoms for each item based on interviews with patients. Prior to the study, the principal investigator will brief the staff on the details of the observation items and confirm that patients are free of all observed symptoms before spatial nebulization begins.
The primary endpoint is to confirm safety by assessing the incidence of adverse events based on the health observation sheet.
Adverse events
There were no adverse events in either the ion-free hypochlorous acid water group or the tap water group, and the 95percent confidence intervals were 0from13.0 percent for the ion-free hypochlorous acid water group and 0from22.0 percent for the tap water group.percent
Outcome measures
The observation items on the health observation sheet include itchy eyes, red eyes, sore throat, runny nose, cough, the smell of hypochlorous acid water, and stress caused by the sound of the nebulizer.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 09 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 06 | Month | 08 | Day |
Last modified on
| 2026 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070704
