IHT for Mild Cognitive Impairment (NCT05495087) | Clinical Trial Compass
RecruitingNot Applicable
IHT for Mild Cognitive Impairment
United States66 participantsStarted 2023-02-27
Plain-language 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).
Who can participate
Age range55 Years – 79 Years
SexALL
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Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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,…
What they're measuring
1
Overall Cognitive Function
Timeframe: Change from baseline after 12-week interventions
2
Attention and Short-term Memory
Timeframe: Change from baseline after 12-week interventions with IHT or sham-IHT
3
Cognitive Function in digit-verbal memory
Timeframe: Change from baseline after 12-week interventions
4
Visual Orientation and Executive Function
Timeframe: Change from baseline after 12-week interventions
Trial details
NCT IDNCT05495087
SponsorUniversity of North Texas Health Science Center