Intermittent Hypoxia for Aging

Overseen By Darren Casey, PHD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Darren P Casey

Disqualifiers: Cardiovascular events, Hypertension, Sleep apnea, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how intermittent hypoxia (short periods of low oxygen) might enhance brain and blood vessel health in older adults. It includes participants with and without type 2 diabetes, testing two intermittent hypoxia methods, Intermittent Hypoxia 1 (IH1) and Intermittent Hypoxia 2 (IH2), against a placebo treatment of normal oxygen levels. Suitable candidates for this trial are individuals aged 60 to 85, either with type 2 diabetes diagnosed over a year ago or non-diabetic adults in the same age range. The trial aims to determine if intermittent hypoxia can offer a new approach to improving health for those aging or managing diabetes. As an unphased trial, participants contribute to pioneering research that may lead to innovative health solutions for aging and diabetes management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team to understand any specific requirements.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that intermittent hypoxia, which involves short periods of lower oxygen levels, is usually well-tolerated and might benefit older adults. Studies have found that this treatment can enhance quality of life, mental abilities, and physical health. Some research even suggests it could help with issues like increased body fat and weaker bones.

However, very low oxygen levels can harm the brain. The key is to carefully control the extent and duration of oxygen reduction. Current studies suggest that short cycles of reduced oxygen are safe for most people. While more research is needed to fully understand any possible risks, existing evidence supports its safety and potential benefits for older adults. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about intermittent hypoxia (IH) techniques because they offer a novel approach to addressing aging, distinct from current methods like dietary supplements or exercise regimens. Unlike traditional treatments that focus on adding nutrients or physical activity, IH involves exposing the body to cycles of low oxygen levels followed by normal oxygen, which may trigger beneficial physiological responses. This technique could potentially enhance cellular resilience and improve overall health without the need for continuous medication or invasive procedures. By exploring IH, scientists hope to uncover a natural, non-invasive way to promote healthy aging.

What evidence suggests that this trial's treatments could be effective for improving cerebrovascular health in older adults?

This trial will compare two different intermittent hypoxia treatments with a sham normoxia control. Research suggests that short periods of low oxygen, known as intermittent hypoxia (IH), might address aging issues like increased body fat and weaker bones. Studies have shown that IH can enhance health and performance. This treatment involves brief exposure to low oxygen, which may benefit brain health and combat age-related diseases. Although insufficient oxygen can be harmful, controlled IH might improve brain blood flow. These early findings are promising, but further research is needed to confirm its benefits for older adults. ^{3 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for older adults aged 60-85 with Type 2 diabetes who can consent to the study and score at least 26 on a cognitive test called MoCA. It's not specified, but typically people with certain health conditions or taking conflicting medications might be excluded.

Inclusion Criteria

I am willing to sign and understand the consent form for this study.

I have been diagnosed with Type 2 diabetes.

I scored 26 or higher on the MoCA cognitive test.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intermittent hypoxia or normoxia over 50 minutes, with 5 cycles of normoxia/hypoxia

8 weeks

Weekly visits for treatment sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Intermittent Hypoxia 1 (IH1)
• Intermittent Hypoxia 2 (IH2)
• SHAM - normoxia

Trial Overview The study is testing two levels of intermittent hypoxia (IH1 and IH2) against a placebo (SHAM-normoxia) to see if they improve brain health in older adults with Type 2 diabetes. Participants are randomly assigned to one of these treatments.

How Is the Trial Designed?

Group I: Intermittent Hypoxia 2 Experimental Treatment 1 Intervention

Participants will receive intermittent hypoxia (5 cycles of normoxia/hypoxia over 50 minutes).

Group II: Intermittent Hypoxia 1 Experimental Treatment 1 Intervention

Participants will receive intermittent hypoxia (5 cycles of normoxia/hypoxia over 50 minutes).

Group III: Normoxia Placebo Group 1 Intervention

Participants will receive normoxia over 50 minutes.

Who Is Running the Clinical Trial?

Darren P Casey

Lead Sponsor

Trials

2

Recruited

80+

American Diabetes Association

Collaborator

Trials

148

Recruited

102,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9103404/

Intermittent Hypoxia as a Therapeutic Tool to Improve ... The intermittent hypoxia might be a useful therapeutic tool to deal with problems associated with aging, such as the increase in body fat, the loss of bone ...

2. frontiersin.org frontiersin.org/journals/aging-neuroscience/articles/10.3389/fnagi.2022.878278/full

Effects of Intermittent Hypoxia in Training Regimes and in ... This review aims to systematically summarize the available studies on the effects of IHNT, IHHT, and OSA on aging and age-related diseases.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1568163721000908

Hypoxia and brain aging: Neurodegeneration or ... Hypoxia is a central factor in brain aging and the development of age-related neurological diseases. Severe hypoxia is detrimental to the brain.

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/mco2.786

Hypoxia and aging: molecular mechanisms, diseases, and ... This review explores the interconnected roles of hypoxia in aging, highlighting how hypoxic conditions exacerbate cellular damage, promote ...

5. nature.com nature.com/articles/s12276-019-0233-3

Hypoxia and aging | Experimental & Molecular Medicine When the oxygen demand exceeds its supply, the oxygen levels in local tissues or the whole body decrease (termed hypoxia), leading to a metabolic crisis.

6. link.springer.com link.springer.com/article/10.1007/s40520-023-02655-w

Effects of intermittent hypoxia and whole-body vibration ... Strength training under intermittent hypoxic conditions has been shown to have therapeutic effects on individual's health.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9168371/

Effects of Intermittent Hypoxia in Training Regimes and in ... IHHT and IHNT provide positive effects on several age-related parameters including quality of life, cognitive and physical functions, plasma level of glucose ...