IHT for Mild Cognitive Impairment

Part of paid clinical trials in Fort Worth, Texas.

Sponsor
University of North Texas Health Science Center
Study ID
NCT05495087
Status
Recruiting
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Conditions

  • Memory Impairment
  • Mild Cognitive Impairment

Eligibility Criteria

Sex
ALL
Age
55 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • 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
    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 Details

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).

Key Dates

Start date
Feb 27, 2023
Status verified
Apr 2026
Primary completion
Apr 30, 2026
Completion
Apr 30, 2026

Study Design

Enrollment
66 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IHT Treatment
    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.
  • Placebo Comparator: Sham-IHT control
    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.

Primary Outcome Measure

Overall Cognitive Function [ Time Frame: Change from baseline after 12-week interventions ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North Texas Health Science CenterFort WorthTexas76107
Xiangrong Shi, PhD
[email protected]
8177352689

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By research site
University of North Texas Health Science Center· Fort Worth, TX

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