RecruitingNot ApplicableNCT03736382

Mild Intermittent Hypoxia and Its Multipronged Effect on Sleep Apnea

Mild Intermittent Hypoxia and CPAP: A Multi-pronged Approach to Treat Sleep Apnea in Intact and Spinal Cord Injured Humans


Sponsor

Wayne State University

Enrollment

40 participants

Start Date

Nov 15, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

Mild intermittent hypoxia (IH) initiates sustained increases in chest wall and upper airway muscle activity in humans. This sustained increase is a form of respiratory plasticity known as long-term facilitation (LTF). Repeated daily exposure to mild IH that leads to the initiation of LTF of upper airway muscle activity could lead to increased stability of the upper airway. In line with PI's laboratory's mandate to develop innovative therapies to treat sleep apnea, this increased stability could ultimately reduce the continuous positive airway pressure (CPAP) required to treat obstructive sleep apnea (OSA) and improve compliance with this gold standard treatment. Improved compliance could ultimately serve to mitigate those comorbidities linked to sleep apnea. Moreover, in addition to improving CPAP compliance numerous studies indicate that mild IH has many direct beneficial effects on cardiovascular, neurocognitive and metabolic function. Thus, mild IH could serve as a multipronged therapeutic approach to treat sleep apnea. In accordance with this postulation, our proposal will determine if repeated daily exposure to mild IH serves as an adjunct therapy coupled with CPAP to mitigate associated co-morbidities via its direct effects on a variety of cardiovascular, metabolic and neurocognitive measures and indirectly by improving CPAP compliance. Modifications in autonomic (i.e. sympathetic nervous system activity) and cardiovascular (i.e. blood pressure) function will be the primary outcome measures coupled to secondary measures of metabolic and neurocognitive outcomes.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria9

  • Body mass index < 40 kg/m\^2.
  • to 60 years old.
  • Newly diagnosed sleep apnea (i.e. apnea/hypopnea index < 100 events per hour - average nocturnal oxygen saturation > 85 %) that has not been treated.
  • Diagnosed with prehypertension or Stage 1 hypertension as categorized by the American Heart Association
  • Not pregnant.
  • Normal lung function.
  • Minimal alcohol consumption (i.e. no more than the equivalent of a glass of wine/day)
  • A typical sleep/wake schedule (i.e. participants will not be night shift workers or have recently travelled across time zones).
  • For spinal cord injured participants (Aim-2): incomplete spinal cord lesions at C3 or below and above T12 (greater than 36 mos. post-SCI) without joint contractures but with signs of voluntary ankle, knee and hip movements and the ability to ambulate at least one step without human assistance.

Exclusion Criteria4

  • Any disease other than high blood pressure and sleep apnea.
  • Medications for high blood pressure and sleep promoting supplements including melatonin
  • Current effective CPAP usage (greater than 4 hours per night).
  • Night Shift workers or recently traveled across time zones.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERMild intermittent hypoxia

Participants will be exposed to twelve two minute episodes of mild intermittent hypoxia 5 days a week for 3 weeks.

OTHERSham protocol

Participants will be exposed to twelve two minute episodes of sham mild intermittent hypoxia (i.e. room air) 5 days a week for 3 weeks.

OTHERContinuous positive airway pressure (CPAP)

All participants will be treated with CPAP each night for a duration of 3 weeks.


Locations(2)

John D Dingell VA Medical Center

Detroit, Michigan, United States

Wayne State University

Detroit, Michigan, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03736382


Related Trials