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IHT for Mild Cognitive Impairment

ConditionsMild Cognitive ImpairmentMemory Impairment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-79
SponsorUniversity of North Texas Health Science Center

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • IHT Treatment

    Device

    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 Control

    Other intervention

    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.

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: IHT TreatmentExperimental treatment 1 intervention
Group B: Sham-IHT controlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Change from baseline after 12-week interventions
2

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.

Time frame
Change from baseline after 12-week interventions with IHT or sham-IHT
3

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.

Time frame
Change from baseline after 12-week interventions
4

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.

Time frame
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.

Time frame
before vs after up to 12-week intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of North Texas Health Science Center

Lead sponsor

University of Texas Southwestern Medical Center

Collaborator

National Institute on Aging (NIA)

Collaborator

Source ClinicalTrials.gov
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