Mild Cognitive ImpairmentNCT05495087
IHT for Mild Cognitive Impairment
A study testing IHT Treatment in people with Mild Cognitive Impairment and Memory Impairment, run by University of North Texas Health Science Center at 1 site in United States.
Trial summary
This phase I clinical trial will examine the safety and efficacy of intermittent hypoxia training (IHT) for up to 12 weeks to treat subjects with mild cognitive impairment (MCI). Read more about this study
- Who is it for?
- Ages 55 to 79 years
- Conditions the study is for
- Mild Cognitive Impairment, Memory Impairment
- What is being tested?
- IHT Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2023to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult men and women ages 55 to 79 years old who have been diagnosed with MCI.
- Must be willing to be assigned to either group: treatment or sham-treatment control.
- Able to pay multiple visits to the lab for the proposed assessments.
- Able to breathe moderately hypoxic air via an air-cushioned, disposable facemask.
- To have controlled stabilized chronic conditions of at least 6 months duration, such as hypertension, coronary artery disease, diabetes or metabolic disease, chronic bronchitis, degenerative osteoporosis or arthritis and/or other aging-related chronic conditions.
- Must be depression-free at the time of enrollment.
- Must have arterial oxygen saturation at or above 95% and cerebral tissue oxygenation at or above 50% at rest.
- Woman subject must be post-menopausal.
Who cannot join
- Unwilling to sign a written consent to participate in this double-blinded placebo-controlled phase I trial.
- Diagnosed with AD-dementia or have impaired independent daily functioning; with MMSE <20 and/or CDR ≥1.
- Unable to visit the lab independently.
- Claustrophobic to facemask and hyper-reactive to hypoxia exposure.
- Expecting any major surgery or transplant.
- Have un-controlled chronic conditions including systolic-diastolic pressures over 150/90 mmHg with medications, diabetes, chronic renal failure (based on the medical history questionnaire), recurrent chest pain, seizures or epilepsies, moderate to severe carotid stenosis or calcification, brain aneurysm, uncontrolled allergic rhinitis, pulmonary fibrosis, emphysema, cancer, infectious disease, atrial fibrillation, regular pre-mature ventricular contractions, myocardial ischemia or infarct, 2nd or 3rd degree atrio-ventricular blockade.
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- Have severe head injury or traumatic brain injury, stroke (hemorrhagic and/or ischemic).
- Have currently diagnosed depression.
- Currently have COVID-19.
- Have any metallic implants or who are claustrophobic.
- Currently participating in any interventional study and/or have been previously exposed to hypoxia, such as residing more than two months at altitudes above 5000 ft. within the past 3 years or previously participated in a hypoxia training study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of North Texas Health Science Center
Fort Worth, Texas, 76107
Xiangrong Shi, PhD, 8177352689, xiangrong.shi@unthsc.edu
About this study
Official title: Intermittent Hypoxia Training: A Novel Therapy for Mild Cognitive Impairment
This phase I clinical trial will examine the safety and efficacy of intermittent hypoxia training (IHT) for up to 12 weeks to treat subjects with mild cognitive impairment (MCI).
Read the detailed description
Volunteer subjects 55-79 years age will sign an informed consent and complete a medical history form. The number of recruited minority subjects will be targeted to approximate the ethnic/racial demographics of the general population in Fort Worth-Dallas area. After they pass the physical screening, all subjects must have an orientation visit in the lab to ensure the ability to tolerate wearing a face masker and breathing hypoxia air up to 5 minutes. In addition, they must undergo a series of cognitive assessments including clinical dementia rating to be determined to have MCI. Only the subjects who have been diagnosed with MCI are eligible to enroll to the study. Up to 66 MCI subjects will be recruited and assigned to two groups: intervention group to have intermittent hypoxia training (IHT) or control group with sham-IHT. The subjects in IHT group will breathe 10% O2 up to 5-min periods alternated with 5-min recovery on room air, repeated for 8 cycles per session, 3 sessions/week up to 12 weeks. The subjects in sham-IHT group will breathe 21% O2 and room air, each 5 min per cycle, for 8 cycles per session, 3 sessions/week for 12 weeks. Before and after 12-week interventions, the subjects' cognitive performances (including short-term memory, concentration ability, visuospatial orientation, and executive function), cardiovascular function during mental, physical and physiological challenges, blood plasma EPO, BDNF, and beta-amyloid proteins, carotid arterial morphology and function, brain MRI will be assessed and compared. In addition, the subjects' short-term memory, concentration ability, visuospatial orientation, and executive function in both groups will be assessed after 5-week and 8-week interventions to determine the IHT effect of a dose-response on the cognitive functions.
- Conditions
- Mild Cognitive Impairment, Memory Impairment
- Being tested
- IHT Treatment, Sham-IHT Control
- Keywords
- intermittent hypoxia training or preconditioning
- Medical subject headings
- Cognitive Dysfunction, Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IHT TreatmentDevice
IHT Treatment: IH exposure to 10% O2 for up to 5 min, interspersed with breathing room air recovery for up to 5 min, with up to 8 cycles/session, 3 sessions/week, for up to 12 weeks.
Sham-IHT ControlOther
Sham-IHT Control: Exposure to 21% O2 for up to 5 min, interspersed with breathing room air recovery for up to 5 min, with up to 8 cycles/session, 3 sessions/week, for up to 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| IHT Treatment | Experimental | 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. Receives: Device: IHT Treatment |
| Sham-IHT control | Placebo comparator | 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. Receives: Other: Sham-IHT Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Cognitive Function
Change in scores or points (from 0 to 30) in Mini-mental State Examination. Higher scores indicate better testing performance or function.
Measured: Change from baseline after 12-week interventions
Attention and Short-term Memory
Change in scores or points in California-Verbal Learning Test - 2nd edition (CVLT-II), and Brief Visuospatial Memory Test - Revised (BVMT-R). Immediate Free-Recall (FR) and delay FR for word-verbal memory and visuospatial memory.
Measured: Change from baseline after 12-week interventions with IHT or sham-IHT
Cognitive Function in digit-verbal memory
Change in scores or points in Digit-Span test - Forward, backward and sequence. Digit-Span recalls test attention and short-term memory. More correct recalls indicate better testing performance and function in digit-verbal memory.
Measured: Change from baseline after 12-week interventions
Visual Orientation and Executive Function
Change in time to complete Trail-making tests. Less time (in sec) to complete the tests indicates better performance and function in executive function, attention and processing speed.
Measured: Change from baseline after 12-week interventions
Secondary outcomes (1)
Brain Morphology
Cortical volume assessed by brain MRI scans. Increased cerebral cortical gray matter indicates a better outcome.
Measured: before vs after up to 12-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start27 Feb 2023
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies 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
- Model description
- IHT vs Sham-IHT Control
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Texas Health Science Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas Southwestern Medical Center, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Xiangrong Shi, University of North Texas Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05495087
- Sponsor's protocol ID
- R01AG076675
- Other IDs
- R01AG076675
- Status last verified
- Apr 2026
- First submitted
- 13 Jul 2022
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Hypoxia Training: A Novel Therapy for Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT05495087
- Acronym / sponsor ID
- R01AG076675
- Conditions
- Mild Cognitive Impairment, Memory Impairment
- Keywords
- intermittent hypoxia training or preconditioning
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- University of North Texas Health Science CenterUniversity, hospital or other
- Collaborators
- University of Texas Southwestern Medical Center, National Institute on Aging (NIA)
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 10 Aug 2022 (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.
This phase I clinical trial will examine the safety and efficacy of intermittent hypoxia training (IHT) for up to 12 weeks to treat subjects with mild cognitive impairment (MCI).
Detailed description
Volunteer subjects 55-79 years age will sign an informed consent and complete a medical history form. The number of recruited minority subjects will be targeted to approximate the ethnic/racial demographics of the general population in Fort Worth-Dallas area. After they pass the physical screening, all subjects must have an orientation visit in the lab to ensure the ability to tolerate wearing a face masker and breathing hypoxia air up to 5 minutes. In addition, they must undergo a series of cognitive assessments including clinical dementia rating to be determined to have MCI. Only the subjects who have been diagnosed with MCI are eligible to enroll to the study. Up to 66 MCI subjects will be recruited and assigned to two groups: intervention group to have intermittent hypoxia training (IHT) or control group with sham-IHT. The subjects in IHT group will breathe 10% O2 up to 5-min periods alternated with 5-min recovery on room air, repeated for 8 cycles per session, 3 sessions/week up to 12 weeks. The subjects in sham-IHT group will breathe 21% O2 and room air, each 5 min per cycle, for 8 cycles per session, 3 sessions/week for 12 weeks. Before and after 12-week interventions, the subjects' cognitive performances (including short-term memory, concentration ability, visuospatial orientation, and executive function), cardiovascular function during mental, physical and physiological challenges, blood plasma EPO, BDNF, and beta-amyloid proteins, carotid arterial morphology and function, brain MRI will be assessed and compared. In addition, the subjects' short-term memory, concentration ability, visuospatial orientation, and executive function in both groups will be assessed after 5-week and 8-week interventions to determine the IHT effect of a dose-response on the cognitive functions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- IHT vs Sham-IHT Control
| Arm | Type | Receives |
|---|---|---|
| IHT Treatment | Experimental | Device: IHT TreatmentExposures 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. |
| Sham-IHT control | Placebo comparator | Other: Sham-IHT ControlExposures 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. |
Who may qualify
- Ages
- 55 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adult men and women ages 55 to 79 years old who have been diagnosed with MCI.
- Must be willing to be assigned to either group: treatment or sham-treatment control.
- Able to pay multiple visits to the lab for the proposed assessments.
- Able to breathe moderately hypoxic air via an air-cushioned, disposable facemask.
- To have controlled stabilized chronic conditions of at least 6 months duration, such as hypertension, coronary artery disease, diabetes or metabolic disease, chronic bronchitis, degenerative osteoporosis or arthritis and/or other aging-related chronic conditions.
Key exclusion criteria (11 listed)
- Unwilling to sign a written consent to participate in this double-blinded placebo-controlled phase I trial.
- Diagnosed with AD-dementia or have impaired independent daily functioning; with MMSE <20 and/or CDR ≥1.
- Unable to visit the lab independently.
- Claustrophobic to facemask and hyper-reactive to hypoxia exposure.
- Expecting any major surgery or transplant.
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 |
|---|---|---|
| IHT TreatmentIHT Treatment: IH exposure to 10% O2 for up to 5 min, interspersed with breathing room air recovery for up to 5 min, with up to 8 cycles/session, 3 sessions/week, for up to 12 weeks. | Device | IHT Treatment |
| Sham-IHT ControlSham-IHT Control: Exposure to 21% O2 for up to 5 min, interspersed with breathing room air recovery for up to 5 min, with up to 8 cycles/session, 3 sessions/week, for up to 12 weeks. | Other | Sham-IHT control |
Primary outcome
Overall Cognitive Function
Time frame: Change from baseline after 12-week interventions
Change in scores or points (from 0 to 30) in Mini-mental State Examination. Higher scores indicate better testing performance or function.
Attention and Short-term Memory
Time frame: Change from baseline after 12-week interventions with IHT or sham-IHT
Change in scores or points in California-Verbal Learning Test - 2nd edition (CVLT-II), and Brief Visuospatial Memory Test - Revised (BVMT-R). Immediate Free-Recall (FR) and delay FR for word-verbal memory and visuospatial memory.
Cognitive Function in digit-verbal memory
Time frame: Change from baseline after 12-week interventions
Change in scores or points in Digit-Span test - Forward, backward and sequence. Digit-Span recalls test attention and short-term memory. More correct recalls indicate better testing performance and function in digit-verbal memory.
Visual Orientation and Executive Function
Time frame: Change from baseline after 12-week interventions
Change in time to complete Trail-making tests. Less time (in sec) to complete the tests indicates better performance and function in executive function, attention and processing speed.
1 secondary outcome
Brain Morphology
Time frame: before vs after up to 12-week intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IHT Treatment in people with Mild Cognitive Impairment and Memory Impairment, run by University of North Texas Health Science Center 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 8 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 29 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiangrong Shi, PhD (817-735-2073, xiangrong.shi@unthsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Cognitive Function (time frame: Change from baseline after 12-week interventions). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2026.