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IHT for Mild Cognitive Impairment

N/A

Recruiting

Research Sponsored by University of North Texas Health Science Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to breathe moderately hypoxic air via an air-cushioned, disposable facemask

Adult men and women ages 55 to 79 years old who have been diagnosed with MCI

Must not have

Have severe head injury or traumatic brain injury, stroke (hemorrhagic and/or ischemic)

Currently have COVID-19

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline 5-week, 8-week, and up to 12-week intervention

Summary

This trial will test whether a breathing program can help improve mild memory loss.

Who is the study for?

This trial is for adults aged 55-79 with mild cognitive impairment (MCI). Participants must be depression-free, post-menopausal if female, have certain stable chronic conditions, and able to visit the lab. Exclusions include major upcoming surgery, current severe illnesses like uncontrolled hypertension or diabetes, recent high-altitude living, metal implants, or claustrophobia to facemasks.

What is being tested?

The study tests intermittent hypoxia training (IHT) versus a sham control over 12 weeks to see if it's safe and effective for improving memory in people with MCI. Participants will breathe moderately hypoxic air through a mask and are randomly assigned to either the treatment or placebo group.

What are the potential side effects?

Potential side effects of IHT may include discomfort from wearing a facemask and reactions to breathing hypoxic air such as dizziness or headaches. Since this is an early-phase trial assessing safety, detailed side effect profiles will be determined during the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can breathe through a special mask with less oxygen.

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I am between 55 and 79 years old and have been diagnosed with mild cognitive impairment.

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I am a woman and have gone through menopause.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a severe head or brain injury, or a stroke.

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I currently have COVID-19.

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I do not have uncontrolled chronic conditions like high blood pressure or diabetes.

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I am expecting to undergo major surgery or receive a transplant.

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I cannot go to the lab by myself.

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I am not willing to sign consent for a double-blinded trial.

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I have been diagnosed with depression recently.

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I have been diagnosed with Alzheimer's dementia or struggle with daily tasks due to my condition, and my mental exams show advanced impairment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline 5-week, 8-week, and up to 12-week intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline 5-week, 8-week, and up to 12-week intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline 5-week, 8-week, and up to 12-week intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Memory

Cognitive Function

Overall Cognitive Function

+1 more

Secondary study objectives

Brain Morphology

Cerebral Vascular Function

Neuroprotective Protein

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: IHT TreatmentExperimental Treatment1 Intervention

Exposures to hypoxic air (10% O2) up to 5 min intermittent with up to 5 min recovery (breathing room air) per session, 3 sessions/week, up to 12 weeks.

Group II: Sham-IHT controlPlacebo Group1 Intervention

Exposures to normoxic air (21% O2) up to 5 min intermittent with up to 5 min recovery (breathing room air) per session, 3 sessions/week, up to 12 weeks.

0 / 11Eligibility criteria met