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NCT06250452
Effect of Halotherapy in Children With Asthma
Phase 1 trial testing Halotherapy (Salt Therapy) in Therapy, Oxygen Inhalation in 70 participants. Completed in 1 June 2024.
1 May 2024
Quick facts
| Lead sponsor | Igdir University |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | supportive care |
| Enrollment | 70 |
| Start date | 6 March 2024 |
| Primary completion | 1 May 2024 |
| Estimated completion | 1 June 2024 |
| Sites | 2 locations across Turkey (Türkiye) |
Drugs / interventions tested
- Halotherapy (Salt Therapy)
Conditions studied
- Therapy, Oxygen Inhalation — all drugs for Therapy, Oxygen Inhalation →
Sponsor
Igdir University
Who can join
Adults 4 to 10, any sex, with Therapy, Oxygen Inhalation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06250452 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Igdir University
- Last refreshed: 2 August 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06250452.
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