Obesity(IHHTOP)NCT06451601
Intermittent Hypoxia-hyperoxia Therapy in Obese Patients (IHHTOP)
A study testing Intermittent hypoxia-hyperoxia therapy in people with Obesity, run by Balnear and Rehabilitation Sanatorium Techirghiol at 1 site in Romania.
Trial summary
Obesity represents the excessive or abnormal accumulation of adipose tissue in the body, which affects health through its association with the risk of developing diabetes mellitus, cardiovascular and pulmonary diseases and hypertension. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Obesity
- What is being tested?
- Intermittent hypoxia-hyperoxia therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteRomania
- Study dates
- 1 Apr 2024to 15 May 2024
- Phase
- Interventional
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with BMI >30 kg/m2
- aged between 40-75 years
- patients to sign the informed consent form
- patients to be compensated and to have medical treatment for associated pathologies
Who cannot join
- BMI <30 kg/m2
- age under 40 or over 75 years
- refusal to sign the informed consent form
- patients presenting contraindications to intermittent hypoxia-hyperoxia therapy
- patients presenting contraindications to complex medical rehabilitation treatment
Trial locations and contacts
1 site in 1 country.
Romania1 site
Balneal and Rehabilitation Sanatorium Techirghio
Techirghiol, Constanța County, 906100
About this study
Official title: The Metabolic and Respiratory Effects of Intermittent Hypoxia-hyperoxia Therapy in Obese Patients Within the Complex Management of Medical Rehabilitation
Obesity represents the excessive or abnormal accumulation of adipose tissue in the body, which affects health through its association with the risk of developing diabetes mellitus, cardiovascular and pulmonary diseases and hypertension.
Obesity can cause significant respiratory changes, so obese patients present pulmonary complications more frequently than individuals with normal weight.
Read more
Intermittent hypoxia (IH) represents the alternation between repeated episodes of hypoxia interspersed with normoxic episodes. Intermittent hypoxia-hyperoxia is the therapy that uses hyperoxic intervals instead of normoxic ones between hypoxic breathing sessions.
This study aimed to evaluate the effectiveness of intermittent hypoxia-hyperoxia therapy among obese patients, focusing on metabolic and respiratory effects. The study aimed to determine if this method could bring benefits in managing or alleviating the complications associated with obesity.
A total of 70 obese patients will be recruited and randomized to either the IHHT group or the control group. The intervention group will receive IHHT while the control group will not receive this therapy.
All patients will be assessed at baseline and after 2 weeks of treatment using a variety of clinical and functional measures. The study's results will be used to determine whether IHHT benefits the patients who follow it.
This study is designed to contribute to the existing body of knowledge on treating obese patients. The results of the study will be of interest to clinicians, researchers, and patients.
Read the detailed description
The study was a prospective, randomized controlled, unicentric study conducted at the Balneal and Rehabilitation Sanatorium Techirghiol (BRST) in Romania. A total of 70 obese patients (BMI > 30 kg/m2) were enrolled in the study. The patients were randomly assigned to either the IHHT group or the control group.
Patients in the intervention group received intermittent hypoxia-hyperoxia therapy and patients in the control group did not receive this therapy. Simultaneously with the intermittent hypoxia-hyperoxia therapy, the patients benefited from complex balneo-physical-kinetic treatment which included hydrokinetotherapy and hydrothermotherapy using specific natural environmental factors: sapropelic mud and salt water from Lake Techirghiol, electrotherapy, massage therapy and kinetotherapy.
The 35 patients in the IHHT group underwent intermittent hypoxia-hyperoxia therapy using the CellOxy Device. During the hypoxic phases, patients received concentrations of 9-16% O2, while during the hyperoxic phases, approximately 35% O2 was administered.
During both testing and actual therapy sessions, patients remained in a comfortable position, lying on a bed. Initially, patients performed hypoxic tests 1 and 2, to determine the optimal oxygen level and to be included in a typology (type I, II, or III). Based on the obtained data, the device automatically calculated and planned personalized IHHT sessions for each patient.
Starting from the following day, patients in the IHHT group were subjected to intermittent hypoxia-hyperoxia as follows: hypoxia with 9-16% O2 for 5-7 minutes, followed by exposure to hyperoxia with ~35% O2 for 2-5 minutes. During the sessions, both SpO2 and heart rate were constantly monitored using the device's built-in pulse oximeter.
In total, patients in the IHHT group performed 9 sessions of hypoxic-hyperoxic therapy: testing on the first day (hypoxic tests 1 and 2), followed by 4 days of sessions in the first week, 2 days of rest on the weekend and then another 5 days of sessions in the second week.
The initial assessment of patients consisted of a comprehensive medical examination, which identified their comorbidities, family history, verification of medication for associated pathologies and behavioral factors (smoking, alcohol consumption, psychosocial stress).
All patients underwent the following measurements: resting blood pressure (BP), heart rate (HR), blood oxygen saturation (SpO2), anthropometric data: height (cm), body weight (kg), waist circumference (cm), and hip circumference (cm), BMI calculation, blood sampling (urea, uric acid, creatinine, glucose, total cholesterol, AST, ALT). Regardless of the presence or absence of changes in the analysis results, patients were included in the study. We consider it important to investigate the entire spectrum of the studied patients, including those with evident changes in their analyses and those with normal results, to obtain a comprehensive and representative image of the researched phenomenon. The patients also performed a 6-minute walk test and a spirometry.
After completing the 2 weeks of treatment at the Balneal and Rehabilitation Sanatorium of Techirghiol, the final assessment identified the same parameters as followed initially.
The statistical analysis was performed using IBM SPSS statistics software version 25. Data are presented as mean ± standard deviation (SD) for continuous variables in case of symmetric distributions, median and IQR (Interquartile range IQR = P75-P25) for numerical discrete variables or for continuous variables in case of skewed distributions, or as frequencies and percentages for categorical variables. The normality of the continuous data was estimated with Shapiro-Wilk Tests of Normality. For hypotheses testing: Independent Samples Mann Whitney U test, Related Samples Wilcoxon Signed Rank Test, Chi-Square Test of association, were used depending on the type of analyzed variables. Spearman's correlation coefficient was used as a statistical measure of the strength of a relationship between paired data. The significance level α was set at 0.05. If the test statistic for every conducted test was in the critical region, and the p-value was less than or equal to the significance level, we decided to reject the null hypothesis in favor of the alternative hypothesis.
- Conditions
- Obesity
- Being tested
- Intermittent hypoxia-hyperoxia therapy
- Keywords
- intermittent hypoxia hyperoxia therapy, metabolic effects, respiratory effects, medical rehabilitation
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent hypoxia-hyperoxia therapyDevice
Data on demographics and clinical conditions was gathered. The investigators collect the next features: sex, age, occupation, environment, body mass index, nutritional status, abdominal circumference, hip circumference, smoking, alcohol. Also, the patients performed a 6-minute walking test.
Other Names:
- Hydrokinetotherapy
- Hydrothermotherapy
- Electrotherapy
- Massage therapy
- Kinetotherapy
| Study group | Role | What they receive |
|---|---|---|
| IHHT Group | Experimental | IHHT group with 35 patients: The patients in the IHHT group underwent intermittent hypoxia-hyperoxia therapy using the CellOxy Device.Initially, patients performed hypoxic tests 1 and 2, to determine the optimal oxygen level and to be included in a typology (type I, II, or III).
Starting from the following day, patients in the IHHT group were subjected to intermittent hypoxia-hyperoxia as follows: hypoxia with 9-16% O2 for 5-7 minutes, followed by exposure to hyperoxia with ~35% O2 for 2-5 minutes.
In total, patients in the IHHT group performed 9 sessions of hypoxic-hyperoxic therapy: testing on the first day (hypoxic tests 1 and 2), followed by 4 days of sessions in the first week, 2 days of rest on the weekend and then another 5 days of sessions in the second week. Simultaneously with the intermittent hypoxia-hyperoxia therapy, the patients benefited from complex balneo-physical-kinetic treatment. Receives: Device: Intermittent hypoxia-hyperoxia therapy |
| Control Group | Active comparator | Control group with 35 patients: The control group completed only the comprehensive balneo-physical-kinetic treatment (hydrokinetotherapy and hydrothermotherapy using specific natural environmental factors: sapropelic mud and salt water from Lake Techirghiol, electrotherapy, massage therapy and kinetotherapy), without intermittent hypoxia-hyperoxia therapy, neither real nor simulated. Receives: Device: Intermittent hypoxia-hyperoxia therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic effects
Blood sampling (urea, uric acid, creatinine, glucose, total cholesterol). The Units of Measure for these biomarkers = mg/dL.
Measured: Two measurements, at the beginning of treatment and after 2 weeks of treatment.
Metabolic effects
Blood sampling (AST, ALT). The Units of Measure for these biomarkers = U/L.
Measured: Two measurements, at the beginning of treatment and after 2 weeks of treatment.
Secondary outcomes (2)
Respiratory effects
Spirometry (FVC, FEV1). The Units of Measure = l.
Measured: Two measurements, at the beginning of treatment and after 2 weeks of treatment.
Respiratory effects
Spirometry (FEV1/FVC ). The Units of Measure = %.
Measured: Two measurements, at the beginning of treatment and after 2 weeks of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start1 Apr 2024
- Primary completion6 May 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Balnear and Rehabilitation Sanatorium Techirghiol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena-Valentina Ionescu, Balnear and Rehabilitation Sanatorium Techirghiol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451601
- Sponsor's protocol ID
- AndreeaUzun
- Acronym
- (IHHTOP)
- Status last verified
- Jun 2024
- First submitted
- 24 May 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Chamarthi VS, Daley SF. Comprehensive Assessment and Diagnosis of Metabolic and Biomechanical Complications in Obesity. 2025 Aug 29. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK459357/
PubMed 29083734Lin X, Li H. Obesity: Epidemiology, Pathophysiology, and Therapeutics. Front Endocrinol (Lausanne). 2021 Sep 6;12:706978. doi: 10.3389/fendo.2021.706978. eCollection 2021.
PubMed 34552557Thompson WG, Cook DA, Clark MM, Bardia A, Levine JA. Treatment of obesity. Mayo Clin Proc. 2007 Jan;82(1):93-101; quiz 101-2. doi: 10.4065/82.1.93.
PubMed 17285790Bischoff SC, Schweinlin A. Obesity therapy. Clin Nutr ESPEN. 2020 Aug;38:9-18. doi: 10.1016/j.clnesp.2020.04.013. Epub 2020 May 11.
PubMed 32690184Dixon AE, Peters U. The effect of obesity on lung function. Expert Rev Respir Med. 2018 Sep;12(9):755-767. doi: 10.1080/17476348.2018.1506331. Epub 2018 Aug 14.
PubMed 30056777Collins LC, Hoberty PD, Walker JF, Fletcher EC, Peiris AN. The effect of body fat distribution on pulmonary function tests. Chest. 1995 May;107(5):1298-302. doi: 10.1378/chest.107.5.1298.
PubMed 7750322Hegewald MJ. Impact of obesity on pulmonary function: current understanding and knowledge gaps. Curr Opin Pulm Med. 2021 Mar 1;27(2):132-140. doi: 10.1097/MCP.0000000000000754.
PubMed 33394747Beuther DA, Sutherland ER. Overweight, obesity, and incident asthma: a meta-analysis of prospective epidemiologic studies. Am J Respir Crit Care Med. 2007 Apr 1;175(7):661-6. doi: 10.1164/rccm.200611-1717OC. Epub 2007 Jan 18.
PubMed 17234901Ford ES, Cunningham TJ, Mercado CI. Lung function and metabolic syndrome: Findings of National Health and Nutrition Examination Survey 2007-2010. J Diabetes. 2014 Nov;6(6):603-13. doi: 10.1111/1753-0407.12136.
PubMed 26677470Burtscher M, Gatterer H, Szubski C, Pierantozzi E, Faulhaber M. Effects of interval hypoxia on exercise tolerance: special focus on patients with CAD or COPD. Sleep Breath. 2010 Sep;14(3):209-20. doi: 10.1007/s11325-009-0289-8. Epub 2009 Aug 18.
PubMed 19688232Glazychev OS. [Optimization of clinical application of interval hypoxic training]. Med Tekh. 2013 May-Jun;(3):21-4. No abstract available. Russian.
PubMed 24003497Uzun AB, Iliescu MG, Stanciu LE, Ionescu EV, Ungur RA, Ciortea VM, Irsay L, Motoasca I, Popescu MN, Popa FL, Pazara L, Tofolean DE. Effectiveness of Intermittent Hypoxia-Hyperoxia Therapy in Different Pathologies with Possible Metabolic Implications. Metabolites. 2023 Jan 25;13(2):181. doi: 10.3390/metabo13020181.
PubMed 36837800Glazachev OS, Zvenigorodskaia LA, Dudnik EN, Iartseva LA, Mishchenkova TV, Platonenko AV, Spirina GK. [Interval hypoxic-hyperoxic training in the treatment of the metabolic syndrome]. Eksp Klin Gastroenterol. 2010;(7):51-6. Russian.
PubMed 21033083Costalat G, Lemaitre F, Tobin B, Renshaw G. Intermittent hypoxia revisited: a promising non-pharmaceutical strategy to reduce cardio-metabolic risk factors? Sleep Breath. 2018 Mar;22(1):267-271. doi: 10.1007/s11325-017-1459-8. Epub 2017 Feb 2.
PubMed 28155101Afina AB, Oleg SG, Alexander AB, Ines D, Alexander Yu S, Nikita VV, Denis ST, Daria GG, Zhang Y, Chavdar SP, Dmitriy VG, Elena AS, Irina VK, Philippe Yu K. The Effects of Intermittent Hypoxic-Hyperoxic Exposures on Lipid Profile and Inflammation in Patients With Metabolic Syndrome. Front Cardiovasc Med. 2021 Aug 27;8:700826. doi: 10.3389/fcvm.2021.700826. eCollection 2021.
PubMed 34513946
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Metabolic and Respiratory Effects of Intermittent Hypoxia-hyperoxia Therapy in Obese Patients Within the Complex Management of Medical Rehabilitation
- ClinicalTrials.gov ID
- NCT06451601
- Acronym / sponsor ID
- (IHHTOP) / AndreeaUzun
- Conditions
- Obesity
- Keywords
- intermittent hypoxia hyperoxia therapy, metabolic effects, respiratory effects, medical rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Balnear and Rehabilitation Sanatorium TechirghiolUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 6 May 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 11 Jun 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.
Obesity represents the excessive or abnormal accumulation of adipose tissue in the body, which affects health through its association with the risk of developing diabetes mellitus, cardiovascular and pulmonary diseases and hypertension.
Obesity can cause significant respiratory changes, so obese patients present pulmonary complications more frequently than individuals with normal weight.
Intermittent hypoxia (IH) represents the alternation between repeated episodes of hypoxia interspersed with normoxic episodes. Intermittent hypoxia-hyperoxia is the therapy that uses hyperoxic intervals instead of normoxic ones between hypoxic breathing sessions.
This study aimed to evaluate the effectiveness of intermittent hypoxia-hyperoxia therapy among obese patients, focusing on metabolic and respiratory effects. The study aimed to determine if this method could bring benefits in managing or alleviating the complications associated with obesity.
A total of 70 obese patients will be recruited and randomized to either the IHHT group or the control group. The intervention group will receive IHHT while the control group will not receive this therapy.
All patients will be assessed at baseline and after 2 weeks of treatment using a variety of clinical and functional measures. The study's results will be used to determine whether IHHT benefits the patients who follow it.
This study is designed to contribute to the existing body of knowledge on treating obese patients. The results of the study will be of interest to clinicians, researchers, and patients.
Detailed description
The study was a prospective, randomized controlled, unicentric study conducted at the Balneal and Rehabilitation Sanatorium Techirghiol (BRST) in Romania. A total of 70 obese patients (BMI > 30 kg/m2) were enrolled in the study. The patients were randomly assigned to either the IHHT group or the control group.
Patients in the intervention group received intermittent hypoxia-hyperoxia therapy and patients in the control group did not receive this therapy. Simultaneously with the intermittent hypoxia-hyperoxia therapy, the patients benefited from complex balneo-physical-kinetic treatment which included hydrokinetotherapy and hydrothermotherapy using specific natural environmental factors: sapropelic mud and salt water from Lake Techirghiol, electrotherapy, massage therapy and kinetotherapy.
The 35 patients in the IHHT group underwent intermittent hypoxia-hyperoxia therapy using the CellOxy Device. During the hypoxic phases, patients received concentrations of 9-16% O2, while during the hyperoxic phases, approximately 35% O2 was administered.
During both testing and actual therapy sessions, patients remained in a comfortable position, lying on a bed. Initially, patients performed hypoxic tests 1 and 2, to determine the optimal oxygen level and to be included in a typology (type I, II, or III). Based on the obtained data, the device automatically calculated and planned personalized IHHT sessions for each patient.
Starting from the following day, patients in the IHHT group were subjected to intermittent hypoxia-hyperoxia as follows: hypoxia with 9-16% O2 for 5-7 minutes, followed by exposure to hyperoxia with ~35% O2 for 2-5 minutes. During the sessions, both SpO2 and heart rate were constantly monitored using the device's built-in pulse oximeter.
In total, patients in the IHHT group performed 9 sessions of hypoxic-hyperoxic therapy: testing on the first day (hypoxic tests 1 and 2), followed by 4 days of sessions in the first week, 2 days of rest on the weekend and then another 5 days of sessions in the second week.
The initial assessment of patients consisted of a comprehensive medical examination, which identified their comorbidities, family history, verification of medication for associated pathologies and behavioral factors (smoking, alcohol consumption, psychosocial stress).
All patients underwent the following measurements: resting blood pressure (BP), heart rate (HR), blood oxygen saturation (SpO2), anthropometric data: height (cm), body weight (kg), waist circumference (cm), and hip circumference (cm), BMI calculation, blood sampling (urea, uric acid, creatinine, glucose, total cholesterol, AST, ALT). Regardless of the presence or absence of changes in the analysis results, patients were included in the study. We consider it important to investigate the entire spectrum of the studied patients, including those with evident changes in their analyses and those with normal results, to obtain a comprehensive and representative image of the researched phenomenon. The patients also performed a 6-minute walk test and a spirometry.
After completing the 2 weeks of treatment at the Balneal and Rehabilitation Sanatorium of Techirghiol, the final assessment identified the same parameters as followed initially.
The statistical analysis was performed using IBM SPSS statistics software version 25. Data are presented as mean ± standard deviation (SD) for continuous variables in case of symmetric distributions, median and IQR (Interquartile range IQR = P75-P25) for numerical discrete variables or for continuous variables in case of skewed distributions, or as frequencies and percentages for categorical variables. The normality of the continuous data was estimated with Shapiro-Wilk Tests of Normality. For hypotheses testing: Independent Samples Mann Whitney U test, Related Samples Wilcoxon Signed Rank Test, Chi-Square Test of association, were used depending on the type of analyzed variables. Spearman's correlation coefficient was used as a statistical measure of the strength of a relationship between paired data. The significance level α was set at 0.05. If the test statistic for every conducted test was in the critical region, and the p-value was less than or equal to the significance level, we decided to reject the null hypothesis in favor of the alternative hypothesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IHHT Group | Experimental | Device: Intermittent hypoxia-hyperoxia therapyIHHT group with 35 patients: The patients in the IHHT group underwent intermittent hypoxia-hyperoxia therapy using the CellOxy Device.Initially, patients performed hypoxic tests 1 and 2, to determine the optimal oxygen level and to be included in a typology (type I, II, or III). Starting from the following day, patients in the IHHT group were subjected to intermittent hypoxia-hyperoxia as follows: hypoxia with 9-16% O2 for 5-7 minutes, followed by exposure to hyperoxia with ~35% O2 for 2-5 minutes. In total, patients in the IHHT group performed 9 sessions of hypoxic-hyperoxic therapy: testing on the first day (hypoxic tests 1 and 2), followed by 4 days of sessions in the first week, 2 days of rest on the weekend and then another 5 days of sessions in the second week. Simultaneously with the intermittent hypoxia-hyperoxia therapy, the patients benefited from complex balneo-physical-kinetic treatment. |
| Control Group | Active comparator | Device: Intermittent hypoxia-hyperoxia therapyControl group with 35 patients: The control group completed only the comprehensive balneo-physical-kinetic treatment (hydrokinetotherapy and hydrothermotherapy using specific natural environmental factors: sapropelic mud and salt water from Lake Techirghiol, electrotherapy, massage therapy and kinetotherapy), without intermittent hypoxia-hyperoxia therapy, neither real nor simulated. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with BMI >30 kg/m2
- aged between 40-75 years
- patients to sign the informed consent form
- patients to be compensated and to have medical treatment for associated pathologies
Key exclusion criteria (5 listed)
- BMI <30 kg/m2
- age under 40 or over 75 years
- refusal to sign the informed consent form
- patients presenting contraindications to intermittent hypoxia-hyperoxia therapy
- patients presenting contraindications to complex medical rehabilitation treatment
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 |
|---|---|---|
| Intermittent hypoxia-hyperoxia therapyData on demographics and clinical conditions was gathered. The investigators collect the next features: sex, age, occupation, environment, body mass index, nutritional status, abdominal circumference, hip circumference, smoking, alcohol. Also, the patients performed a 6-minute walking test. Other Names: * Hydrokinetotherapy * Hydrothermotherapy * Electrotherapy * Massage therapy * Kinetotherapy | Device | Control Group, IHHT Group |
Primary outcome
Metabolic effects
Time frame: Two measurements, at the beginning of treatment and after 2 weeks of treatment.
Blood sampling (urea, uric acid, creatinine, glucose, total cholesterol). The Units of Measure for these biomarkers = mg/dL.
Metabolic effects
Time frame: Two measurements, at the beginning of treatment and after 2 weeks of treatment.
Blood sampling (AST, ALT). The Units of Measure for these biomarkers = U/L.
2 secondary outcomes
Respiratory effects
Time frame: Two measurements, at the beginning of treatment and after 2 weeks of treatment.
Respiratory effects
Time frame: Two measurements, at the beginning of treatment and after 2 weeks of treatment.
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 11 Jun 2024.
- Background: PubMed 29083734Chamarthi VS, Daley SF. Comprehensive Assessment and Diagnosis of Metabolic and Biomechanical Complications in Obesity. 2025 Aug 29. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK459357/
- Background: PubMed 34552557Lin X, Li H. Obesity: Epidemiology, Pathophysiology, and Therapeutics. Front Endocrinol (Lausanne). 2021 Sep 6;12:706978. doi: 10.3389/fendo.2021.706978. eCollection 2021.
- Background: PubMed 17285790Thompson WG, Cook DA, Clark MM, Bardia A, Levine JA. Treatment of obesity. Mayo Clin Proc. 2007 Jan;82(1):93-101; quiz 101-2. doi: 10.4065/82.1.93.
- Background: PubMed 32690184Bischoff SC, Schweinlin A. Obesity therapy. Clin Nutr ESPEN. 2020 Aug;38:9-18. doi: 10.1016/j.clnesp.2020.04.013. Epub 2020 May 11.
- Background: PubMed 30056777Dixon AE, Peters U. The effect of obesity on lung function. Expert Rev Respir Med. 2018 Sep;12(9):755-767. doi: 10.1080/17476348.2018.1506331. Epub 2018 Aug 14.
- Background: PubMed 7750322Collins LC, Hoberty PD, Walker JF, Fletcher EC, Peiris AN. The effect of body fat distribution on pulmonary function tests. Chest. 1995 May;107(5):1298-302. doi: 10.1378/chest.107.5.1298.
- Background: PubMed 33394747Hegewald MJ. Impact of obesity on pulmonary function: current understanding and knowledge gaps. Curr Opin Pulm Med. 2021 Mar 1;27(2):132-140. doi: 10.1097/MCP.0000000000000754.
- Background: PubMed 17234901Beuther DA, Sutherland ER. Overweight, obesity, and incident asthma: a meta-analysis of prospective epidemiologic studies. Am J Respir Crit Care Med. 2007 Apr 1;175(7):661-6. doi: 10.1164/rccm.200611-1717OC. Epub 2007 Jan 18.
- Background: PubMed 26677470Ford ES, Cunningham TJ, Mercado CI. Lung function and metabolic syndrome: Findings of National Health and Nutrition Examination Survey 2007-2010. J Diabetes. 2014 Nov;6(6):603-13. doi: 10.1111/1753-0407.12136.
- Background: PubMed 19688232Burtscher M, Gatterer H, Szubski C, Pierantozzi E, Faulhaber M. Effects of interval hypoxia on exercise tolerance: special focus on patients with CAD or COPD. Sleep Breath. 2010 Sep;14(3):209-20. doi: 10.1007/s11325-009-0289-8. Epub 2009 Aug 18.
- Background: PubMed 24003497Glazychev OS. [Optimization of clinical application of interval hypoxic training]. Med Tekh. 2013 May-Jun;(3):21-4. No abstract available. Russian.
- Background: PubMed 36837800Uzun AB, Iliescu MG, Stanciu LE, Ionescu EV, Ungur RA, Ciortea VM, Irsay L, Motoasca I, Popescu MN, Popa FL, Pazara L, Tofolean DE. Effectiveness of Intermittent Hypoxia-Hyperoxia Therapy in Different Pathologies with Possible Metabolic Implications. Metabolites. 2023 Jan 25;13(2):181. doi: 10.3390/metabo13020181.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent hypoxia-hyperoxia therapy in people with Obesity, run by Balnear and Rehabilitation Sanatorium Techirghiol at 1 site in Romania.
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 4 inclusion and 5 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 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. 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.
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?
Metabolic effects (time frame: Two measurements, at the beginning of treatment and after 2 weeks of treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06451601, which also lists 30 linked publications.
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 11 Jun 2024.