Therapy, Oxygen InhalationPhase 1NCT06250452
Effect of Halotherapy in Children With Asthma
A Phase 1 study testing Halotherapy (Salt Therapy) in people with Therapy, Oxygen Inhalation, run by Igdir University at 2 sites in Turkey (Türkiye).
Trial summary
Introduction: Asthma is a chronic respiratory disease that can affect all age groups and is characterized by episodic and reversible wheezing, shortness of breath, chest tightness and cough attacks. Read more about this study
- Who is it for?
- Ages 4 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Therapy, Oxygen Inhalation
- What is being tested?
- Halotherapy (Salt Therapy)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 6 Mar 2024to 1 Jun 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Asthma diagnosis
- Being a child between the ages of 4-10
- Volunteering to participate in research
Who cannot join
- Under 4 years of age and over 10 years of age
- Any other chronic disease
- not agree to participate in the research
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Eda Gülbetekin
Iğdır, Iğdır, 76000
Eda Gülbetekin
Iğdır, 76000
About this study
Official title: Effect of Halotherapy (Salt Therapy) on Oxygen Saturation (SPO2), Asthma Symptoms and Treatment Need in Children With Asthma
Introduction: Asthma is a chronic respiratory disease that can affect all age groups and is characterized by episodic and reversible wheezing, shortness of breath, chest tightness and cough attacks. According to a 2016 report by the United States Department of Disease Control and Prevention (CDC), the prevalence of asthma was 9.6% in children aged 5-11 and 10.5% in children aged 12-17. It has been shown that the prevalence of asthma under the age of 18, which concerns all childhoods, is 8.3%.
Purpose: The aim of the study is to determine the effect of salt therapy rooms on the oxygen saturation, asthma symptoms and treatment needs of children with asthma.
Material Method: The research was planned as an experimental study with experimental and control groups. Participants to be included in the study will be children between the ages of 4-10, diagnosed with asthma and without any other chronic diseases, who volunteer to participate. "Personal Information Form", "SPO2 measurements", "Asthma Symptom and Treatment Need Scoring / Daily Follow-up Form" and "Informed Voluntary Consent Form" will be used to collect data. The sample of the research was calculated using the GPower computer program. With power analysis, t-test in independent groups with a large effect size at α = 0.05 (d = 0.8) and in the calculation made to have a power of 95% of the study, it was found that a total of 70 children, 35 children in the control group and experimental groups, should be included. . "Personal Information Form", SPO2 measurement and Asthma Symptom and Treatment Need Scoring / Daily Follow-up Form" will be applied to the children in the experimental group before they are taken to the salt therapy room. The same procedure will be applied to the children in the control group. In the study planned to be carried out for 6 weeks, it is recommended that children repeat the session for 10 minutes daily, the first 5 sessions every day and the other 5 weeks once a week.
Read the detailed description
"Salt therapy," known as halotherapy, is a treatment method performed in salt chambers lined with salt crystals that are pumped with salt-laden air and is used to combat respiratory diseases, skin conditions, mental fatigue and stress. The word Halos means salt in Greek. This practice is also performed in naturally occurring salt mines or caves in Eastern European countries, which is called "speleotherapy" or "cave salt therapy".
Salt has been used for thousands of years in different parts of the world due to its therapeutic effect, and was first applied for therapeutic purposes by Polish Feliks Bockowski. Although salt mine workers in Poland lack basic needs such as nutrition and have difficult working conditions, their general health has led researchers to study and observe in the salt field. In this observation, it was determined that mine workers were less likely to catch colds or any respiratory system diseases. Salt mines were thought to have health benefits, and salt caves in Eastern Europe and Poland became popular.
The research was planned as an experimental study with experimental and control groups. Participants to be included in the study will be children between the ages of 4-10, diagnosed with asthma and without any other chronic diseases, who volunteer to participate. "Personal Information Form", "SPO2 measurements", "Asthma Symptom and Treatment Need Scoring / Daily Follow-up Form" and "Informed Voluntary Consent Form" will be used to collect data. The sample of the research was calculated using the GPower computer program. With power analysis, t-test in independent groups with a large effect size at α = 0.05 (d = 0.8) and in the calculation made to have a power of 95% of the study, it was found that a total of 70 children, 35 children in the control group and experimental groups, should be included. . "Personal Information Form", SPO2 measurement and Asthma Symptom and Treatment Need Scoring / Daily Follow-up Form" will be applied to the children in the experimental group before they are taken to the salt therapy room. The same procedure will be applied to the children in the control group. In the study planned to be carried out for 6 weeks, it is recommended that children repeat the session for 10 minutes daily, the first 5 sessions every day and the other 5 weeks once a week.
- Conditions
- Therapy, Oxygen Inhalation
- Being tested
- Halotherapy (Salt Therapy)
- Keywords
- Halotherapy, Oxygen Saturation, Asthma, Children with Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Halotherapy (Salt Therapy)Combination product
"Personal Information Form", SPO2 measurement and Asthma Symptom and Treatment Need Scoring / Daily Follow-up Form" will be applied to the children in the experimental group before they are taken to the salt therapy room. Scales and SPO2 measurement will be performed before, during and after therapy. The same procedure will be applied to the children in the control group, but no therapy will be applied. In the study planned to be carried out for 6 weeks, it is recommended that children repeat the session for 10 minutes daily, the first 5 sessions every day and the other 5 weeks once a week.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | "Personal Information Form", SPO2 measurement and Asthma Symptom and Treatment Need Scoring / Daily Follow-up Form" will be applied to the children in the experimental group before they are taken to the salt therapy room. Receives: Combination Product: Halotherapy (Salt Therapy) |
| Control Group | Experimental | The same procedure will be applied to the children in the control group. In the study planned to be carried out for 6 weeks, it is recommended that children repeat the session for 10 minutes daily, the first 5 sessions every day and the other 5 weeks once a week. Receives: Combination Product: Halotherapy (Salt Therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen Saturation (SPO2)
Oxygen saturation is a very important measure of how well the lungs are working.
Measured: for 6 weeks, children were given 10-minute daily sessions, the first 5 sessions every day, the other 5 weeks, once a week.
Secondary outcomes (1)
Asthma Symptom and Treatment Need Scoring
All patients were given a form to record their asthma symptoms at the beginning and end of the study. Daily symptoms (cough, wheezing, shortness of breath) were scored using the scoring system. In this scoring, symptom-free status was scored as 0, mild symptoms as 1, moderate symptoms as 2, and severe symptoms as 3.
Measured: for 6 weeks, children were given 10-minute daily sessions, the first 5 sessions every day, the other 5 weeks, once a week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start6 Mar 2024
- Primary completion1 May 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Therapy, Oxygen InhalationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Igdir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eda Gulbetekin, Igdir University
- Investigators
- Eda Gülbetekin, PhD, Principal investigator, Igdir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250452
- Sponsor's protocol ID
- Eda1
- Status last verified
- Aug 2024
- First submitted
- 23 Jan 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Halotherapy (Salt Therapy) on Oxygen Saturation (SPO2), Asthma Symptoms and Treatment Need in Children With Asthma
- ClinicalTrials.gov ID
- NCT06250452
- Acronym / sponsor ID
- Eda1
- Conditions
- Therapy, Oxygen Inhalation
- Keywords
- Halotherapy, Oxygen Saturation, Asthma, Children with Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Igdir UniversityUniversity, hospital or other
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction: Asthma is a chronic respiratory disease that can affect all age groups and is characterized by episodic and reversible wheezing, shortness of breath, chest tightness and cough attacks. According to a 2016 report by the United States Department of Disease Control and Prevention (CDC), the prevalence of asthma was 9.6% in children aged 5-11 and 10.5% in children aged 12-17. It has been shown that the prevalence of asthma under the age of 18, which concerns all childhoods, is 8.3%.
Purpose: The aim of the study is to determine the effect of salt therapy rooms on the oxygen saturation, asthma symptoms and treatment needs of children with asthma.
Material Method: The research was planned as an experimental study with experimental and control groups. Participants to be included in the study will be children between the ages of 4-10, diagnosed with asthma and without any other chronic diseases, who volunteer to participate. "Personal Information Form", "SPO2 measurements", "Asthma Symptom and Treatment Need Scoring / Daily Follow-up Form" and "Informed Voluntary Consent Form" will be used to collect data. The sample of the research was calculated using the GPower computer program. With power analysis, t-test in independent groups with a large effect size at α = 0.05 (d = 0.8) and in the calculation made to have a power of 95% of the study, it was found that a total of 70 children, 35 children in the control group and experimental groups, should be included. . "Personal Information Form", SPO2 measurement and Asthma Symptom and Treatment Need Scoring / Daily Follow-up Form" will be applied to the children in the experimental group before they are taken to the salt therapy room. The same procedure will be applied to the children in the control group. In the study planned to be carried out for 6 weeks, it is recommended that children repeat the session for 10 minutes daily, the first 5 sessions every day and the other 5 weeks once a week.
Detailed description
"Salt therapy," known as halotherapy, is a treatment method performed in salt chambers lined with salt crystals that are pumped with salt-laden air and is used to combat respiratory diseases, skin conditions, mental fatigue and stress. The word Halos means salt in Greek. This practice is also performed in naturally occurring salt mines or caves in Eastern European countries, which is called "speleotherapy" or "cave salt therapy".
Salt has been used for thousands of years in different parts of the world due to its therapeutic effect, and was first applied for therapeutic purposes by Polish Feliks Bockowski. Although salt mine workers in Poland lack basic needs such as nutrition and have difficult working conditions, their general health has led researchers to study and observe in the salt field. In this observation, it was determined that mine workers were less likely to catch colds or any respiratory system diseases. Salt mines were thought to have health benefits, and salt caves in Eastern Europe and Poland became popular.
The research was planned as an experimental study with experimental and control groups. Participants to be included in the study will be children between the ages of 4-10, diagnosed with asthma and without any other chronic diseases, who volunteer to participate. "Personal Information Form", "SPO2 measurements", "Asthma Symptom and Treatment Need Scoring / Daily Follow-up Form" and "Informed Voluntary Consent Form" will be used to collect data. The sample of the research was calculated using the GPower computer program. With power analysis, t-test in independent groups with a large effect size at α = 0.05 (d = 0.8) and in the calculation made to have a power of 95% of the study, it was found that a total of 70 children, 35 children in the control group and experimental groups, should be included. . "Personal Information Form", SPO2 measurement and Asthma Symptom and Treatment Need Scoring / Daily Follow-up Form" will be applied to the children in the experimental group before they are taken to the salt therapy room. The same procedure will be applied to the children in the control group. In the study planned to be carried out for 6 weeks, it is recommended that children repeat the session for 10 minutes daily, the first 5 sessions every day and the other 5 weeks once a week.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Combination Product: Halotherapy (Salt Therapy)"Personal Information Form", SPO2 measurement and Asthma Symptom and Treatment Need Scoring / Daily Follow-up Form" will be applied to the children in the experimental group before they are taken to the salt therapy room. |
| Control Group | Experimental | Combination Product: Halotherapy (Salt Therapy)The same procedure will be applied to the children in the control group. In the study planned to be carried out for 6 weeks, it is recommended that children repeat the session for 10 minutes daily, the first 5 sessions every day and the other 5 weeks once a week. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Asthma diagnosis
- Being a child between the ages of 4-10
- Volunteering to participate in research
Key exclusion criteria (3 listed)
- Under 4 years of age and over 10 years of age
- Any other chronic disease
- not agree to participate in the research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Halotherapy (Salt Therapy)"Personal Information Form", SPO2 measurement and Asthma Symptom and Treatment Need Scoring / Daily Follow-up Form" will be applied to the children in the experimental group before they are taken to the salt therapy room. Scales and SPO2 measurement will be performed before, during and after therapy. The same procedure will be applied to the children in the control group, but no therapy will be applied. In the study planned to be carried out for 6 weeks, it is recommended that children repeat the session for 10 minutes daily, the first 5 sessions every day and the other 5 weeks once a week. | Combination product | Control Group, experimental group |
Primary outcome
Oxygen Saturation (SPO2)
Time frame: for 6 weeks, children were given 10-minute daily sessions, the first 5 sessions every day, the other 5 weeks, once a week.
Oxygen saturation is a very important measure of how well the lungs are working.
1 secondary outcome
Asthma Symptom and Treatment Need Scoring
Time frame: for 6 weeks, children were given 10-minute daily sessions, the first 5 sessions every day, the other 5 weeks, once a week.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eda Gülbetekin, PhD principal investigator
Igdir University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Halotherapy (Salt Therapy) in people with Therapy, Oxygen Inhalation, run by Igdir University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen Saturation (SPO2) (time frame: for 6 weeks, children were given 10-minute daily sessions, the first 5 sessions every day, the other 5 weeks, once a week.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024.