Intermittent HypoxiaNCT05898685
Effect of a Single Session of Intermittent Hypoxia on Hematological Variables
A study testing Intermittent hypoxia and Intermittent normoxia in people with Intermittent Hypoxia, run by University of Texas at Austin at 1 site in United States.
Trial summary
The purpose of the study is to determine the effect of a single exposure of intermittent hypoxia on erythropoietin levels and hemoglobin mass in young adults, older adults and patients with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Intermittent Hypoxia
- What is being tested?
- Intermittent hypoxia and Intermittent normoxia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2019to 1 Apr 2023
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged 18 to 80 years old
- Adults with type 2 diabetes aged 30 to 80 years old
Who cannot join
- Have high blood pressure (above 140/90 mmHg)
- Are smokers
- Are pregnant
- Have a history of cardiovascular disease, diabetes or lung disease
- Are taking more than one antihypertensive medication
- Are taking insulin or more than one antihypertensive medication
- Have poorly controlled diabetes: HbA1c levels ˃ 9%
- Have been previously diagnosed with diabetic complications (nephropathy, neuropathy, retinopathy) by their family doctor
Trial locations and contacts
1 site in 1 country.
United States1 site
The Unviersity of Texas at Austin
Austin, Texas, 78712
About this study
The purpose of the study is to determine the effect of a single exposure of intermittent hypoxia on erythropoietin levels and hemoglobin mass in young adults, older adults and patients with type 2 diabetes.
Read the detailed description
Cardiorespiratory fitness, assessed by measuring maximal oxygen consumption (VO2max), has a potential to predict cardiovascular disease and mortality risk to a greater extent than smoking, hypertension, type 2 diabetes or high cholesterol levels. Oxygen transport from the lungs to the exercising muscles is achieved through the binding of oxygen to hemoglobin, an iron-containing protein in the red blood cell. Therefore, hemoglobin mass represents the oxygen-carrying capacity of the blood and strongly correlates with VO2max. Patients with type 2 diabetes have serious impairments in cardiorespiratory fitness, as observed through a 20% lower VO2max than individuals matched for age, weight and physical activity levels. The investigators previously showed that a lower hemoglobin mass limits oxygen-carrying capacity and contributes to the lower VO2max in patients with type 2 diabetes. Thus, interventions that can increase hemoglobin mass should result in improved oxygen-carrying capacity and VO2max in patients with type 2 diabetes. While the majority of patients with type 2 diabetes are aware of their need to perform exercise to improve their VO2max, less than 1/3 of patients meet recommended levels of physical activity. There is therefore an urgent need to develop alternative interventions that improve VO2max, as even minimal improvements in VO2max significantly decrease mortality risk in unfit individuals.
Hypoxia deprives the body of adequate oxygen supply at the tissue level which stimulates the release of erythropoietin (EPO), the peptide hormone regulating red blood cell production, in order to restore oxygen supply to the tissues. Following a rise in EPO levels, it takes 5-6 days for a newly created reticulocyte to mature into a red blood cell, and to observe an increased hemoglobin mass. Increases in EPO levels have been observed to reach maximum values approximately 2-3 h after continuous hypoxic exposure lasting between 90 minutes and 3 hours. It has consequently been suggested that intermittent hypoxia, consisting of alternating few minutes of breathing hypoxic air with few minutes of breathing normoxic air, would provide a stimulus sufficient to stimulate an increase in EPO levels and hematological variables. Only one study measured both EPO levels and hematological changes in responses to intermittent hypoxia. Elite distance runners completed 4 weeks of intermittent hypoxia consisting of 5:5-minutes hypoxia-to-normoxia ratio for 70 min, 5 times/week. The fraction of inspired oxygen gradually declined from 0.12 to 0.10%. The authors did not observe any increase in EPO levels or hemoglobin concentration. However, there were several methodological limitations that could explain these findings. First, hemoglobin concentration is dependent on plasma volume and is therefore greatly influenced by hydration status, and correlates only to a modest extent with red blood cell mass. On the other hand, hemoglobin mass is reported in grams and is a more direct measure of oxygen-carrying capacity. Second, EPO measurements were performed at the same time of day to minimize any circadian variability in EPO levels, which likely prevented the detection of a rise in EPO within the first few hours following the exposure to intermittent hypoxia. Therefore, the purpose of the present study is to determine the effect of a single exposure of intermittent hypoxia on EPO levels and hemoglobin mass in healthy individuals. The cardiovascular and ventilatory responses to a single exposure of intermittent hypoxia will also be determined. If intermittent hypoxia improves oxygen-carrying capacity, the next step will be to apply this intervention to patients with type 2 diabetes.
- Conditions
- Intermittent Hypoxia
- Being tested
- Intermittent hypoxia, Intermittent normoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent hypoxiaBehavioural
The intermittent hypoxia protocol will consist of eight 4-minute hypoxic cycles (arterial oxygen saturation of 80%) interspersed with normoxic cycles to resaturation.
Intermittent normoxiaBehavioural
The intermittent normoxia protocol will consist of eight 4-minute normoxic cycles (compressed air) interspersed with 1-minute normoxic cycles (room air)
| Study group | Role | What they receive |
|---|---|---|
| Intermittent hypoxia | Experimental | The intermittent hypoxia protocol will consist of eight 4-minute hypoxic cycles (arterial oxygen saturation of 80%) interspersed with normoxic cycles to resaturation. Receives: Behavioral: Intermittent hypoxia |
| Intermittent normoxia | Sham comparator | The intermittent normoxia protocol will consist of eight 4-minute normoxic cycles (compressed air) interspersed with 1-minute normoxic cycles (room air). Receives: Behavioral: Intermittent normoxia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in erythropoietin levels
Hormone that regulates red blood cell production
Measured: Measured before and 4.5 hours after intermittent hypoxia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start16 Apr 2019
- Primary completion20 Nov 2022
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intermittent HypoxiaStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sophie Lalande, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05898685
- Sponsor's protocol ID
- 2017-09-0015
- Status last verified
- Jun 2023
- First submitted
- 29 May 2023
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wojan F, Stray-Gundersen S, Zhao J, Lalande S. Impaired erythropoietin response to hypoxia in type 2 diabetes. Acta Diabetol. 2024 Jul;61(7):925-932. doi: 10.1007/s00592-024-02269-2. Epub 2024 Apr 4.
PubMed 38570345
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Single Session of Intermittent Hypoxia on Hematological Variables
- ClinicalTrials.gov ID
- NCT05898685
- Acronym / sponsor ID
- 2017-09-0015
- Conditions
- Intermittent Hypoxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 20 Nov 2022 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 12 Jun 2023 (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.
The purpose of the study is to determine the effect of a single exposure of intermittent hypoxia on erythropoietin levels and hemoglobin mass in young adults, older adults and patients with type 2 diabetes.
Detailed description
Cardiorespiratory fitness, assessed by measuring maximal oxygen consumption (VO2max), has a potential to predict cardiovascular disease and mortality risk to a greater extent than smoking, hypertension, type 2 diabetes or high cholesterol levels. Oxygen transport from the lungs to the exercising muscles is achieved through the binding of oxygen to hemoglobin, an iron-containing protein in the red blood cell. Therefore, hemoglobin mass represents the oxygen-carrying capacity of the blood and strongly correlates with VO2max. Patients with type 2 diabetes have serious impairments in cardiorespiratory fitness, as observed through a 20% lower VO2max than individuals matched for age, weight and physical activity levels. The investigators previously showed that a lower hemoglobin mass limits oxygen-carrying capacity and contributes to the lower VO2max in patients with type 2 diabetes. Thus, interventions that can increase hemoglobin mass should result in improved oxygen-carrying capacity and VO2max in patients with type 2 diabetes. While the majority of patients with type 2 diabetes are aware of their need to perform exercise to improve their VO2max, less than 1/3 of patients meet recommended levels of physical activity. There is therefore an urgent need to develop alternative interventions that improve VO2max, as even minimal improvements in VO2max significantly decrease mortality risk in unfit individuals.
Hypoxia deprives the body of adequate oxygen supply at the tissue level which stimulates the release of erythropoietin (EPO), the peptide hormone regulating red blood cell production, in order to restore oxygen supply to the tissues. Following a rise in EPO levels, it takes 5-6 days for a newly created reticulocyte to mature into a red blood cell, and to observe an increased hemoglobin mass. Increases in EPO levels have been observed to reach maximum values approximately 2-3 h after continuous hypoxic exposure lasting between 90 minutes and 3 hours. It has consequently been suggested that intermittent hypoxia, consisting of alternating few minutes of breathing hypoxic air with few minutes of breathing normoxic air, would provide a stimulus sufficient to stimulate an increase in EPO levels and hematological variables. Only one study measured both EPO levels and hematological changes in responses to intermittent hypoxia. Elite distance runners completed 4 weeks of intermittent hypoxia consisting of 5:5-minutes hypoxia-to-normoxia ratio for 70 min, 5 times/week. The fraction of inspired oxygen gradually declined from 0.12 to 0.10%. The authors did not observe any increase in EPO levels or hemoglobin concentration. However, there were several methodological limitations that could explain these findings. First, hemoglobin concentration is dependent on plasma volume and is therefore greatly influenced by hydration status, and correlates only to a modest extent with red blood cell mass. On the other hand, hemoglobin mass is reported in grams and is a more direct measure of oxygen-carrying capacity. Second, EPO measurements were performed at the same time of day to minimize any circadian variability in EPO levels, which likely prevented the detection of a rise in EPO within the first few hours following the exposure to intermittent hypoxia. Therefore, the purpose of the present study is to determine the effect of a single exposure of intermittent hypoxia on EPO levels and hemoglobin mass in healthy individuals. The cardiovascular and ventilatory responses to a single exposure of intermittent hypoxia will also be determined. If intermittent hypoxia improves oxygen-carrying capacity, the next step will be to apply this intervention to patients with type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent hypoxia | Experimental | Behavioral: Intermittent hypoxiaThe intermittent hypoxia protocol will consist of eight 4-minute hypoxic cycles (arterial oxygen saturation of 80%) interspersed with normoxic cycles to resaturation. |
| Intermittent normoxia | Sham comparator | Behavioral: Intermittent normoxiaThe intermittent normoxia protocol will consist of eight 4-minute normoxic cycles (compressed air) interspersed with 1-minute normoxic cycles (room air). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women aged 18 to 80 years old
- Adults with type 2 diabetes aged 30 to 80 years old
Key exclusion criteria (8 listed)
- Have high blood pressure (above 140/90 mmHg)
- Are smokers
- Are pregnant
- Have a history of cardiovascular disease, diabetes or lung disease
- Are taking more than one antihypertensive medication
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 hypoxiaThe intermittent hypoxia protocol will consist of eight 4-minute hypoxic cycles (arterial oxygen saturation of 80%) interspersed with normoxic cycles to resaturation. | Behavioural | Intermittent hypoxia |
| Intermittent normoxiaThe intermittent normoxia protocol will consist of eight 4-minute normoxic cycles (compressed air) interspersed with 1-minute normoxic cycles (room air) | Behavioural | Intermittent normoxia |
Primary outcome
Change in erythropoietin levels
Time frame: Measured before and 4.5 hours after intermittent hypoxia
Hormone that regulates red blood cell production
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 12 Jun 2023.
- Derived from this study: PubMed 38570345Wojan F, Stray-Gundersen S, Zhao J, Lalande S. Impaired erythropoietin response to hypoxia in type 2 diabetes. Acta Diabetol. 2024 Jul;61(7):925-932. doi: 10.1007/s00592-024-02269-2. Epub 2024 Apr 4.
- Individual participant dataSharing planned: No
Related trials for Intermittent Hypoxia
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
Recruiting
Influence of Intermittent Hypoxia on Loop Gain in Healthy Subjects
Intermittent Hypoxia, Healthy Volunteers
Not yet recruiting
Safety and Efficacy of Carotid Artery Stenting Combined With Intermittent Hypoxia Intervention in Patients With Severe Internal Carotid Artery Stenosis
Internal Carotid Artery Stenosis
Recruiting
Brain Connectivity and Corticospinal Excitability in Response to Moderate Hypoxia
Normoxia, Intermittent Moderate Hypoxia
Recruiting
BioFLO for Respiratory Recovery in SCI
Spinal Cord Injuries
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 and Intermittent normoxia in people with Intermittent Hypoxia, run by University of Texas at Austin at 1 site in United States.
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 2 inclusion and 8 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 12 Jun 2023. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Change in erythropoietin levels (time frame: Measured before and 4.5 hours after intermittent hypoxia). 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 NCT05898685, which also lists 1 linked publication.
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 12 Jun 2023.