Intermittent Hypoxia for Brain Health in Type 2 Diabetes

This study is looking at whether Intermittent Hypoxia (IH) can improve brain health in older adults, especially those with Type 2 Diabetes. IH involves breathing air with lower oxygen levels for short periods, similar to being at a high altitude. You would be randomly assigned to receive either Intermittent Hypoxia 1 (IH1), Intermittent Hypoxia 2 (IH2), or a sham treatment (normal air). Researchers will measure blood flow to your brain and your thinking abilities to see if IH helps. We are looking for 80 participants aged 60-85, including 30 with Type 2 Diabetes, who score 26 or higher on a memory test (MoCA). The study's status is currently unclear.

Study design
This is a randomized, placebo-controlled study with 80 planned participants. Participants will be assigned to one of three groups: Intermittent Hypoxia 1, Intermittent Hypoxia 2, or SHAM (normal air).
What's involved
You would participate in 3 sessions per week for either 4 or 8 weeks, depending on your assigned group. Researchers will measure your carotid artery function, brain blood flow, and cognitive function at various times throughout the study.
Compensation
Not stated in the trial record.
Follow-up
Your carotid artery function will be measured up to 8 weeks after the start of the study, and cognitive function up to 8 weeks.

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NCT07173543

IH, Brain Health, and T2D

Recruiting
NAAges 60–85Interventional
Darren P Casey
~80 participants
Updated 2026-03-13 on ClinicalTrials.gov
What's tested:Intermittent Hypoxia 1 (IH1)Intermittent Hypoxia 2 (IH2)SHAM - normoxia

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Internal Carotid Artery (ICA) shear-mediated dilation
Measured over Baseline and post 2-,4-,5-,6-, and 8-weeks
+2 more outcomes measured
Type 2 Diabetes
Aging
1 sites across 1 states
Iowa1

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Eligibility criteria

Inclusion

Willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures.
Age is \> or = 60 and \< or = 85 years of age
Documented Type 2 diabetes
Scoring 26 or higher on the MoCA test
Willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures.
Age is \> or = 60 and \< or = 85 years of age
Scoring 26 or higher on the MoCA test

Exclusion

diagnosis of type 2 diabetes \< 1 year prior to enrollment
HbA1c \<6.5% or \>10.0%
body mass index \> 40 kg/m 2
incident cardiovascular events in the last year (heart attack, stroke)
symptomatic coronary artery disease and/or heart failure
uncontrolled hypertension
obstructive sleep apnea
pulmonary disease
dementia
renal impairment with creatinine clearance (eGFR) of \<60 ml/min
smoking or history of smoking within past one year
Diagnosis of diabetes (Type 1 or Type 2)
body mass index \> 40 kg/m2
incident cardiovascular events in the last year (heart attack, stroke)
symptomatic coronary artery disease and/or heart failure
uncontrolled hypertension
obstructive sleep apnea
pulmonary disease
dementia
renal impairment with creatinine clearance (eGFR) of \<60 ml/min
smoking or history of smoking within past one year
  • Internal Carotid Artery (ICA) shear-mediated dilationBaseline and post 2-,4-,5-,6-, and 8-weeks

    ICA dilation (% change) will be determined using Doppler ultrasound in response to acute hypercapnia.

  • Cerebral blood flow responsivenessBaseline and after 50 minutes of IH or SHAM

    Cerebral blood flow will be determined using Doppler ultrasound in response to acute hypoxia.

  • Cognitive function testingBaseline and post 4- and 8-weeks

    Working memory will be assessed using a facial recognition n-back task test