Intermittent Hypoxia-initiated Plasticity in Humans: A Multi-pronged Therapeutic Approach to Treat Sleep Apnea and Overlapping Co-morbidities

Part of paid clinical trials in Detroit, Michigan.

Sponsor
VA Office of Research and Development
Study ID
NCT05558501
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Obstructive Sleep Apnea

Eligibility Criteria

Sex
ALL
Age
30 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Mild Intermittent Hypoxia — OTHER
    The MIH protocol will be comprised of a 20-minute baseline period followed by exposure to twelve two-minute episodes of hypoxia \[partial pressure of end-tidal oxygen (PETO2)= 50 mmHg\]. Each episode will be interspersed with a 2-minute recovery period under normoxic conditions. The final episode will be followed by a 30-minute end-recovery period. The partial pressure of end-tidal carbon dioxide (PETCO2) will be sustained 2 mmHg above baseline values for the last ten minutes of baseline and throughout the remainder of the protocol. To rapidly induce a PETO2 of 50 mmHg participants will inspire a gas mixture comprised of 8 % oxygen and 92 % nitrogen from a non-diffusible bag. To maintain PETO2 (i.e. 50 mmHg) and PETCO2 (i.e. 2 mmHg above baseline) at the desired levels supplemental oxygen and carbon dioxide will be added to the inspiratory line from the output of a flow meter device that receives inputs from tanks of 100 % oxygen and 100 % carbon dioxide.
  • Sham MIH — OTHER
    During "sham MIH" the participants will be exposed to compressed air (the equivalent of room air).

Study Details

The prevalence of obstructive sleep apnea (OSA) is high in the United States and is a major health concern. This disorder is linked to numerous heart, blood vessel and nervous system abnormalities, along with increased tiredness while performing exercise likely because of a reduced blood supply to skeletal muscles. The gold standard treatment of OSA with continuous positive airway pressure (CPAP) in many cases does not lead to significant improvements in health outcomes because the recommended number of hours of treatment per night is often not achieved. Thus, development of novel treatments to eliminate apnea and lessen the occurrence of associated health conditions is important. The investigators will address this mandate by determining if repeated exposure to mild intermittent hypoxia (MIH) reduces heart and blood vessel dysfunction and tiredness/ fatigue experienced while exercise performance. The investigators propose that exposure to MIH has a multipart effect. MIH directly targets heart and blood vessel associated conditions, while simultaneously increasing upper airway stability and improving sleep quality. These modifications may serve to directly decrease breathing episodes and may also serve to improve usage of CPAP. Independent of its effect, MIH may serve as an adjunctive therapy which provides another path to reducing heart and blood vessel abnormalities that might ultimately result in improvements in exercise capacity and reverse performance fatigue in individuals with OSA.

Key Dates

Start date
Jan 1, 2023
Status verified
Dec 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

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

Arms

  • Experimental: Mild Intermittent Hypoxia (MIH)
    This arm of the protocol will receive mild intermittent hypoxia (8% oxygen) with end-tidal carbon dioxide maintained 2 millimeters of mercury above baseline, while in the laboratory.
  • Sham Comparator: Sham Mild Intermittent Hypoxia (Sham MIH)
    This arm of the protocol will receive sham MIH (the equivalent of room air), while in the laboratory.

Primary Outcome Measure

Change in Blood Pressure [ Time Frame: Change at 15 days, 4 and 8- weeks following treatment compared to baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
John D. Dingell VA Medical Center, Detroit, MIDetroitMichigan48201-1916
Edi Levi, MD
[email protected]
313-576-4451
Erin Olgren, PhD MS
[email protected]
(313) 576-4448
Jason H Mateika, PhD MS BS (PRINCIPAL_INVESTIGATOR)

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By research site
John D. Dingell VA Medical Center, Detroit, MI· Detroit, MI

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