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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline 5-week, 8-week, and up to 12-week intervention
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Memory
Cognitive Function
Overall Cognitive Function
+1 more
Secondary outcome measures
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.

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterOTHER
1,048 Previous Clinical Trials
1,053,709 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,020,859 Total Patients Enrolled
University of North Texas Health Science CenterLead Sponsor
39 Previous Clinical Trials
20,106 Total Patients Enrolled

Media Library

IHT Treatment (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05495087 — N/A
Mild Cognitive Impairment Research Study Groups: IHT Treatment, Sham-IHT control
Mild Cognitive Impairment Clinical Trial 2023: IHT Treatment Highlights & Side Effects. Trial Name: NCT05495087 — N/A
IHT Treatment (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05495087 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are octogenarians being admitted to participate in this venture?

"The requisite age for entry into this clinical trial lies between 55 and 80 years old."

Answered by AI

Are volunteers being recruited for this experiment?

"Per clinicaltrials.gov, this experiment is actively recruiting participants. The first post was made on February 27th 2023 and the most recent update occurred April 3rd of that same year."

Answered by AI

To what extent has enrollment in this research project been successful?

"Affirmative. Clinicaltrials.gov contains data that proves this clinical trial, initially shared on February 27th 2023, is actively recruiting participants. 66 patients must be signed up at a single medical centre to complete the research project."

Answered by AI

Does my profile meet the qualifications necessary to join this scientific trial?

"This research trial is seeking 66 adults, aged 55 to 80 years old and with mild cognitive impairment. In order for patients to be eligible, they must meet the following criteria: men or women of appropriate age range who have been diagnosed with MCI; consenting to either treatment or sham-treatment control group; multiple visits capability; ability to comfortably breathe moderately hypoxic air through a specialised facemask; chronic conditions such as hypertension, coronary artery disease, diabetes etc.; no history of stroke nor obstructive sleep apnea; arterial oxygen saturation over 95% and cerebral tissue oxygenation above 50% during rest period (if female subject"

Answered by AI

What key goals is this research seeking to achieve?

"This 5-week to 12-week intervention is intended to assess the primary objective of Visual Orientation and Executive Function. Secondary objectives include evaluating Brain Morphology (Thickness of cortical gray matter assessed by brain MRI), Neurotoxic Protein (Blood beta-amyloid assessed by enzyme-linked immunosorbent assay) , and Neuroprotective Protein (Blood erythropoietin assessed by enzyme-linked immunosorbent assay). Each outcome aims at detecting a better result through either increased or decreased concentrations, depending on the measure."

Answered by AI
~30 spots leftby Apr 2025